Genitourinary Cancer

Adjuvant radiotherapy after radical prostatectomy provided no meaningful benefit in patients with prostate cancer but increased the risk for urinary and bowel morbidity, compared with men followed with observation alone, according to the latest results from the phase 3 RADICALS-RT trial.

The new findings showed no difference in the rate of 10-year freedom from distant metastases or overall survival in patients who received adjuvant radiotherapy vs. those who underwent observation with salvage radiotherapy if their disease progressed and provided further confirmation of earlier results reported in The Lancet in 2020.

Observation with early salvage radiotherapy in cases of biochemical failure should be the standard of care, concluded study coauthor Noel Clarke, MBBS, who presented the results at the annual meeting of the European Society for Medical Oncology.

Invited discussant and session cochair Shahneed Sandhu, MBBS, said that the findings definitively confirm the value of observation with salvage radiotherapy over adjuvant radiotherapy in this patient population.

“The approach of early salvage radiotherapy spared morbidity [from] radiation in the vast majority of patients, and further bowel and bladder toxicity is reduced in the setting of salvage radiotherapy,” said Dr. Sandhu, an associate professor and consultant medical oncologist at Peter MacCallum Cancer Centre, Victoria, Australia.

The aim of the RADICALS-RT study was to clarify the optimal timing for radiotherapy after radical prostatectomy in men with prostate cancer, which previously had been uncertain.

In the study, 697 patients were randomly assigned to adjuvant radiotherapy and 699 to observation with salvage radiotherapy. Participants had undergone radical prostatectomy; had a postoperative prostate-specific antigen (PSA) level ≤ 0.2 ng/mL; and at least one risk factor for cancer relapse, including pathologic T-stage III or IV, Gleason score of 7-10, positive margins, or preoperative PSA ≥ 10 ng/mL.

Patients in the observation arm received salvage radiotherapy if they experienced two consecutive PSA increases ≥ 0.1 ng/mL or three consecutive rises.

Overall, the investigators found similar rates of 10-year freedom from distant metastases in both arms: 93% in the adjuvant radiotherapy group vs. 90% in the observation group (hazard ratio, 0.68; P = .095). The 10-year overall survival rates were similar as well: 88% in the adjuvant radiotherapy group and 87% in the observation group (HR, 0.98; P = .92).

However, self-reported urinary and fecal incontinence rates at 1 year were significantly higher in the adjuvant radiotherapy group vs. the observation group, 60% of whom had not received salvage radiotherapy at that time.

Secondary outcome measures, including biochemical progression-free survival and time to further hormone therapy, were also similar in the treatment and observation arms.

Overall, the trial results “support the use of early salvage radiotherapy for PSA failure after radical prostatectomy rather than early adjuvant intervention, “ concluded Dr. Clarke, a professor and consultant urologist at the Christie Hospital and Salford Royal Hospital, Manchester, England.

And when biochemical recurrence does occur, Dr. Sandhu noted that prostate-specific membrane antigen PET is increasingly used in practice to help “define the extent of disease” and “tailor radiation fields.”

Dr. Clarke reported serving on advisory boards for Janssen, Astellas, and Bayer. Dr. Sandhu reported receiving research grant support and/or serving as a consultant or adviser for Advanced Accelerator Application (a Novartis company), AstraZeneca, Merck Sharp and Dohme, Roche/Genentech, Amgen, Pfizer, Merck Serono, Bristol-Myers Squibb, Novartis, Janssen, and Sehnwa.

A version of this article first appeared on Medscape.com.

Adjuvant radiotherapy after radical prostatectomy provided no meaningful benefit in patients with prostate cancer but increased the risk for urinary and bowel morbidity, compared with men followed with observation alone, according to the latest results from the phase 3 RADICALS-RT trial.

The new findings showed no difference in the rate of 10-year freedom from distant metastases or overall survival in patients who received adjuvant radiotherapy vs. those who underwent observation with salvage radiotherapy if their disease progressed and provided further confirmation of earlier results reported in The Lancet in 2020.

Observation with early salvage radiotherapy in cases of biochemical failure should be the standard of care, concluded study coauthor Noel Clarke, MBBS, who presented the results at the annual meeting of the European Society for Medical Oncology.

Invited discussant and session cochair Shahneed Sandhu, MBBS, said that the findings definitively confirm the value of observation with salvage radiotherapy over adjuvant radiotherapy in this patient population.

“The approach of early salvage radiotherapy spared morbidity [from] radiation in the vast majority of patients, and further bowel and bladder toxicity is reduced in the setting of salvage radiotherapy,” said Dr. Sandhu, an associate professor and consultant medical oncologist at Peter MacCallum Cancer Centre, Victoria, Australia.

The aim of the RADICALS-RT study was to clarify the optimal timing for radiotherapy after radical prostatectomy in men with prostate cancer, which previously had been uncertain.

In the study, 697 patients were randomly assigned to adjuvant radiotherapy and 699 to observation with salvage radiotherapy. Participants had undergone radical prostatectomy; had a postoperative prostate-specific antigen (PSA) level ≤ 0.2 ng/mL; and at least one risk factor for cancer relapse, including pathologic T-stage III or IV, Gleason score of 7-10, positive margins, or preoperative PSA ≥ 10 ng/mL.

Patients in the observation arm received salvage radiotherapy if they experienced two consecutive PSA increases ≥ 0.1 ng/mL or three consecutive rises.

Overall, the investigators found similar rates of 10-year freedom from distant metastases in both arms: 93% in the adjuvant radiotherapy group vs. 90% in the observation group (hazard ratio, 0.68; P = .095). The 10-year overall survival rates were similar as well: 88% in the adjuvant radiotherapy group and 87% in the observation group (HR, 0.98; P = .92).

However, self-reported urinary and fecal incontinence rates at 1 year were significantly higher in the adjuvant radiotherapy group vs. the observation group, 60% of whom had not received salvage radiotherapy at that time.

Secondary outcome measures, including biochemical progression-free survival and time to further hormone therapy, were also similar in the treatment and observation arms.

Overall, the trial results “support the use of early salvage radiotherapy for PSA failure after radical prostatectomy rather than early adjuvant intervention, “ concluded Dr. Clarke, a professor and consultant urologist at the Christie Hospital and Salford Royal Hospital, Manchester, England.

And when biochemical recurrence does occur, Dr. Sandhu noted that prostate-specific membrane antigen PET is increasingly used in practice to help “define the extent of disease” and “tailor radiation fields.”

Dr. Clarke reported serving on advisory boards for Janssen, Astellas, and Bayer. Dr. Sandhu reported receiving research grant support and/or serving as a consultant or adviser for Advanced Accelerator Application (a Novartis company), AstraZeneca, Merck Sharp and Dohme, Roche/Genentech, Amgen, Pfizer, Merck Serono, Bristol-Myers Squibb, Novartis, Janssen, and Sehnwa.

A version of this article first appeared on Medscape.com.

Adjuvant radiotherapy after radical prostatectomy provided no meaningful benefit in patients with prostate cancer but increased the risk for urinary and bowel morbidity, compared with men followed with observation alone, according to the latest results from the phase 3 RADICALS-RT trial.

The new findings showed no difference in the rate of 10-year freedom from distant metastases or overall survival in patients who received adjuvant radiotherapy vs. those who underwent observation with salvage radiotherapy if their disease progressed and provided further confirmation of earlier results reported in The Lancet in 2020.

Observation with early salvage radiotherapy in cases of biochemical failure should be the standard of care, concluded study coauthor Noel Clarke, MBBS, who presented the results at the annual meeting of the European Society for Medical Oncology.

Invited discussant and session cochair Shahneed Sandhu, MBBS, said that the findings definitively confirm the value of observation with salvage radiotherapy over adjuvant radiotherapy in this patient population.

“The approach of early salvage radiotherapy spared morbidity [from] radiation in the vast majority of patients, and further bowel and bladder toxicity is reduced in the setting of salvage radiotherapy,” said Dr. Sandhu, an associate professor and consultant medical oncologist at Peter MacCallum Cancer Centre, Victoria, Australia.

The aim of the RADICALS-RT study was to clarify the optimal timing for radiotherapy after radical prostatectomy in men with prostate cancer, which previously had been uncertain.

In the study, 697 patients were randomly assigned to adjuvant radiotherapy and 699 to observation with salvage radiotherapy. Participants had undergone radical prostatectomy; had a postoperative prostate-specific antigen (PSA) level ≤ 0.2 ng/mL; and at least one risk factor for cancer relapse, including pathologic T-stage III or IV, Gleason score of 7-10, positive margins, or preoperative PSA ≥ 10 ng/mL.

Patients in the observation arm received salvage radiotherapy if they experienced two consecutive PSA increases ≥ 0.1 ng/mL or three consecutive rises.

Overall, the investigators found similar rates of 10-year freedom from distant metastases in both arms: 93% in the adjuvant radiotherapy group vs. 90% in the observation group (hazard ratio, 0.68; P = .095). The 10-year overall survival rates were similar as well: 88% in the adjuvant radiotherapy group and 87% in the observation group (HR, 0.98; P = .92).

However, self-reported urinary and fecal incontinence rates at 1 year were significantly higher in the adjuvant radiotherapy group vs. the observation group, 60% of whom had not received salvage radiotherapy at that time.

Secondary outcome measures, including biochemical progression-free survival and time to further hormone therapy, were also similar in the treatment and observation arms.

Overall, the trial results “support the use of early salvage radiotherapy for PSA failure after radical prostatectomy rather than early adjuvant intervention, “ concluded Dr. Clarke, a professor and consultant urologist at the Christie Hospital and Salford Royal Hospital, Manchester, England.

And when biochemical recurrence does occur, Dr. Sandhu noted that prostate-specific membrane antigen PET is increasingly used in practice to help “define the extent of disease” and “tailor radiation fields.”

Dr. Clarke reported serving on advisory boards for Janssen, Astellas, and Bayer. Dr. Sandhu reported receiving research grant support and/or serving as a consultant or adviser for Advanced Accelerator Application (a Novartis company), AstraZeneca, Merck Sharp and Dohme, Roche/Genentech, Amgen, Pfizer, Merck Serono, Bristol-Myers Squibb, Novartis, Janssen, and Sehnwa.

A version of this article first appeared on Medscape.com.

TOPLINE:

Adoption of doublet therapy – androgen deprivation therapy (ADT) combined with either docetaxel or an androgen receptor pathway inhibitor – has led to a clinically meaningful increase in long-term survival in men with de novo metastatic castration-sensitive prostate cancer, Swedish registry data show.

METHODOLOGY:

• The use of doublet therapy has increased significantly in Sweden in recent years given the growing body of evidence demonstrating that doublet therapy improves survival in individuals with de novo metastatic castration-sensitive prostate cancer.
• Investigators wanted to see whether the increasing use of doublet therapy in this patient population has improved survival when taking various other factors into consideration.
• The analysis, which included 11,382 men diagnosed with metastatic castration-sensitive prostate cancer in Sweden from 2008-2020 and registered in the country’s National Prostate Cancer Register, explored the use of doublet therapy over time and its association with survival, adjusting for age, comorbidities, and cancer characteristics.
• The researchers estimated average 5-year and 10-year survival over time using a survival model.

TAKEAWAY:

• During the study period, patients exhibited a shift toward less advanced prostate cancer, with median prostate-specific antigen (PSA) levels at diagnosis decreasing from 145 to 107 ng/mL in men with metastatic disease.
• Upfront treatment with doublet therapy in these men simultaneously increased from 1% in 2016 to 44% in 2020.
• Adjusted 5-year overall survival increased from 26% between 2008-2012 to 35% in the period 2017-2020; in the 5 years following diagnosis, patients’ mean survival increased by about 6 months between 2008-2012 and 2017-2020.
• The percentage of patients still alive at 10 years doubled from 9% in 2008 to 18% in 2020. Improvements were greater in men younger than 80 years old.

IN PRACTICE:

“A clinically meaningful increase in long-term survival was observed in men diagnosed with de novo [metastatic castration-sensitive prostate cancer] between 2008 and 2020 in Sweden. We argue that the main reason for this improvement was the increased upfront use of doublet therapy,” the authors concluded.

SOURCE:

The study, with first author Christian Corsini, MD, of Uppsala (Sweden) University, was published online in JAMA Network Open.

LIMITATIONS:

Although there were no substantial changes in the diagnostic workup, unmeasured and unknown changes over the years may have affected survival.  The researchers lacked information on PSA levels during follow-up, and therefore could not assess progression-free survival. Some upfront docetaxel use was not captured before 2017.

DISCLOSURES:

The study received funding from the Swedish Cancer Society and Region Uppsala. The authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

TOPLINE:

Adoption of doublet therapy – androgen deprivation therapy (ADT) combined with either docetaxel or an androgen receptor pathway inhibitor – has led to a clinically meaningful increase in long-term survival in men with de novo metastatic castration-sensitive prostate cancer, Swedish registry data show.

METHODOLOGY:

• The use of doublet therapy has increased significantly in Sweden in recent years given the growing body of evidence demonstrating that doublet therapy improves survival in individuals with de novo metastatic castration-sensitive prostate cancer.
• Investigators wanted to see whether the increasing use of doublet therapy in this patient population has improved survival when taking various other factors into consideration.
• The analysis, which included 11,382 men diagnosed with metastatic castration-sensitive prostate cancer in Sweden from 2008-2020 and registered in the country’s National Prostate Cancer Register, explored the use of doublet therapy over time and its association with survival, adjusting for age, comorbidities, and cancer characteristics.
• The researchers estimated average 5-year and 10-year survival over time using a survival model.

TAKEAWAY:

• During the study period, patients exhibited a shift toward less advanced prostate cancer, with median prostate-specific antigen (PSA) levels at diagnosis decreasing from 145 to 107 ng/mL in men with metastatic disease.
• Upfront treatment with doublet therapy in these men simultaneously increased from 1% in 2016 to 44% in 2020.
• Adjusted 5-year overall survival increased from 26% between 2008-2012 to 35% in the period 2017-2020; in the 5 years following diagnosis, patients’ mean survival increased by about 6 months between 2008-2012 and 2017-2020.
• The percentage of patients still alive at 10 years doubled from 9% in 2008 to 18% in 2020. Improvements were greater in men younger than 80 years old.

IN PRACTICE:

“A clinically meaningful increase in long-term survival was observed in men diagnosed with de novo [metastatic castration-sensitive prostate cancer] between 2008 and 2020 in Sweden. We argue that the main reason for this improvement was the increased upfront use of doublet therapy,” the authors concluded.

SOURCE:

The study, with first author Christian Corsini, MD, of Uppsala (Sweden) University, was published online in JAMA Network Open.

LIMITATIONS:

Although there were no substantial changes in the diagnostic workup, unmeasured and unknown changes over the years may have affected survival.  The researchers lacked information on PSA levels during follow-up, and therefore could not assess progression-free survival. Some upfront docetaxel use was not captured before 2017.

DISCLOSURES:

The study received funding from the Swedish Cancer Society and Region Uppsala. The authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

TOPLINE:

Adoption of doublet therapy – androgen deprivation therapy (ADT) combined with either docetaxel or an androgen receptor pathway inhibitor – has led to a clinically meaningful increase in long-term survival in men with de novo metastatic castration-sensitive prostate cancer, Swedish registry data show.

METHODOLOGY:

• The use of doublet therapy has increased significantly in Sweden in recent years given the growing body of evidence demonstrating that doublet therapy improves survival in individuals with de novo metastatic castration-sensitive prostate cancer.
• Investigators wanted to see whether the increasing use of doublet therapy in this patient population has improved survival when taking various other factors into consideration.
• The analysis, which included 11,382 men diagnosed with metastatic castration-sensitive prostate cancer in Sweden from 2008-2020 and registered in the country’s National Prostate Cancer Register, explored the use of doublet therapy over time and its association with survival, adjusting for age, comorbidities, and cancer characteristics.
• The researchers estimated average 5-year and 10-year survival over time using a survival model.

TAKEAWAY:

• During the study period, patients exhibited a shift toward less advanced prostate cancer, with median prostate-specific antigen (PSA) levels at diagnosis decreasing from 145 to 107 ng/mL in men with metastatic disease.
• Upfront treatment with doublet therapy in these men simultaneously increased from 1% in 2016 to 44% in 2020.
• Adjusted 5-year overall survival increased from 26% between 2008-2012 to 35% in the period 2017-2020; in the 5 years following diagnosis, patients’ mean survival increased by about 6 months between 2008-2012 and 2017-2020.
• The percentage of patients still alive at 10 years doubled from 9% in 2008 to 18% in 2020. Improvements were greater in men younger than 80 years old.

IN PRACTICE:

“A clinically meaningful increase in long-term survival was observed in men diagnosed with de novo [metastatic castration-sensitive prostate cancer] between 2008 and 2020 in Sweden. We argue that the main reason for this improvement was the increased upfront use of doublet therapy,” the authors concluded.

SOURCE:

The study, with first author Christian Corsini, MD, of Uppsala (Sweden) University, was published online in JAMA Network Open.

LIMITATIONS:

Although there were no substantial changes in the diagnostic workup, unmeasured and unknown changes over the years may have affected survival.  The researchers lacked information on PSA levels during follow-up, and therefore could not assess progression-free survival. Some upfront docetaxel use was not captured before 2017.

DISCLOSURES:

The study received funding from the Swedish Cancer Society and Region Uppsala. The authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

SAN DIEGO – With just five fractions of stereotactic body radiation therapy (SBRT), men with low- or intermediate-risk prostate cancer can have 5-year disease control as good as that provided by conventional external-beam radiation therapy delivered at higher doses in 20-39 fractions, according to new data from the phase 3 randomized PACE-B trial.

Overall, the 5-year event-free survival rates were 95.8% among patients who received SBRT and 94.6% among those who had conventional radiation. The incidence of adverse events was also low in both groups, with no significant differences observed between the trial arms.

The similar event-free survival and toxicity profiles in both groups provide more support for SBRT, which treats prostate cancer with larger radiation fractions over a shorter time period.

“I think we can also say now with a high level of confidence that SBRT can be considered a new standard of care for low and favorable intermediate-risk prostate cancer,” said Nicholas van As, MD, MB, from the Royal Marsden NHS Foundation Trust and Institute of Cancer Research in London, who presented efficacy and safety results from the noninferiority trial at the American Society for Radiation Oncology (ASTRO) annual meeting. SBRT is more convenient for patients and more cost-effective for health care providers, Dr. Van As added.

Invited discussant Alejandro Berlin, MD, MSc, from Princess Margaret Cancer Centre and the University of Toronto, agreed “that this should be a standard of care for low and favorable intermediate-risk prostate cancer,” an option already endorsed by relevant guidelines.

But, Dr. Berlin noted, SBRT requires careful attention to technique to achieve the desired results. Further research will be needed to identify and potentially reduce variability among radiation oncology practice regarding margins, dosimetry goals, dose heterogeneity, treatment schedules, and other factors, he said.
 

An international trial

PACE-B is one of three branches of a multi-center collaboration among 37 radiation therapy centers in the United Kingdom, Ireland, and Canada.

In the trial, investigators enrolled 874 patients with T1c or T2c prostate cancer, Gleason score of 3+4 or less, prostate-specific antigen (PSA) level no higher than 20 ng/mL, MRI staging, and no prior androgen deprivation therapy. Investigators then randomly assigned them on a 1:1 basis to receive either conventional radiation (n = 441) or SBRT (n = 433).

At the start of the trial, patients who were assigned to the conventional radiation group received 78 Gy in 39 fractions over 4-8 weeks. However, after results from the CHHiP trial, which showed that a 60-Gy, 20-fraction regimen was not inferior to a 74-Gy, 37-fraction regimen, the PACE-B investigators modified the protocol to 62 Gy delivered in 20 fractions.

Patients assigned to SBRT received 36.25 Gy divided into give fractions delivered over 1-2 weeks, with 40 Gy to the clinical target volume.

The primary outcome was noninferiority of SBRT, measured as whether patients remained free of biochemical clinical failure. Biochemical clinical failure was defined as evidence that the cancer was returning, such as an increase in PSA levels or distant metastases or death from prostate cancer.

At a median follow-up of 73.1 months, 5-year event-free survival rates were 94.6% for patients who received conventional radiation therapy and 95.8% for patients who received SBRT, meeting the prespecified criteria for noninferiority of SBRT (P = .007).

Freedom from biochemical and clinical failure, the trial’s primary endpoint, “was significantly better on both arms than our original power calculation, where we expected control rates of approximately 85%,” Dr. Van As said in an ASTRO plenary session.

Toxicity rates were also low in both study arms. The rate of grade 2 or greater urogenital side effects at 5 years was 5.5% in the SBRT arm and 3.2% in the conventional therapy arm. Grade 2 or greater gastrointestinal side effects occurred in only two patients, one in each study arm.

Given the findings, “I think it’s now imperative that our surgeons discuss this data with their patients before they perform prostatectomies,” Dr. Van As said.

Neha Vapiwala, MD, president-elect of ASTRO who moderated a media briefing where Dr. Van As summarized the PACE-B data, commented that “this study was conducted very rigorously, with excellent quality assurance.”

The study also highlights that clinicians in the United States have considerable catching up to do, said Dr. Vapiwala, from the Hospital of the University of Pennsylvania, Philadelphia.

In the United States, “we are way behind our colleagues on the other side of the pond,” she said. “We are way behind in our uptake of ultra-hypofractionated radiation [such as SBRT], and I do believe that some of that comes from the lack of feeling comfortable with the techniques that are needed and the expertise that is needed.”

PACE-B was funded by Accuray. Dr. Van As disclosed research grants from the company and consulting fees from Varian. Dr. Berlin reported no conflict of interest relevant to the study. Dr. Vapiwala has disclosed a consulting or advisory role with Bayer.

A version of this article first appeared on Medscape.com.

SAN DIEGO – With just five fractions of stereotactic body radiation therapy (SBRT), men with low- or intermediate-risk prostate cancer can have 5-year disease control as good as that provided by conventional external-beam radiation therapy delivered at higher doses in 20-39 fractions, according to new data from the phase 3 randomized PACE-B trial.

Overall, the 5-year event-free survival rates were 95.8% among patients who received SBRT and 94.6% among those who had conventional radiation. The incidence of adverse events was also low in both groups, with no significant differences observed between the trial arms.

The similar event-free survival and toxicity profiles in both groups provide more support for SBRT, which treats prostate cancer with larger radiation fractions over a shorter time period.

“I think we can also say now with a high level of confidence that SBRT can be considered a new standard of care for low and favorable intermediate-risk prostate cancer,” said Nicholas van As, MD, MB, from the Royal Marsden NHS Foundation Trust and Institute of Cancer Research in London, who presented efficacy and safety results from the noninferiority trial at the American Society for Radiation Oncology (ASTRO) annual meeting. SBRT is more convenient for patients and more cost-effective for health care providers, Dr. Van As added.

Invited discussant Alejandro Berlin, MD, MSc, from Princess Margaret Cancer Centre and the University of Toronto, agreed “that this should be a standard of care for low and favorable intermediate-risk prostate cancer,” an option already endorsed by relevant guidelines.

But, Dr. Berlin noted, SBRT requires careful attention to technique to achieve the desired results. Further research will be needed to identify and potentially reduce variability among radiation oncology practice regarding margins, dosimetry goals, dose heterogeneity, treatment schedules, and other factors, he said.
 

An international trial

PACE-B is one of three branches of a multi-center collaboration among 37 radiation therapy centers in the United Kingdom, Ireland, and Canada.

In the trial, investigators enrolled 874 patients with T1c or T2c prostate cancer, Gleason score of 3+4 or less, prostate-specific antigen (PSA) level no higher than 20 ng/mL, MRI staging, and no prior androgen deprivation therapy. Investigators then randomly assigned them on a 1:1 basis to receive either conventional radiation (n = 441) or SBRT (n = 433).

At the start of the trial, patients who were assigned to the conventional radiation group received 78 Gy in 39 fractions over 4-8 weeks. However, after results from the CHHiP trial, which showed that a 60-Gy, 20-fraction regimen was not inferior to a 74-Gy, 37-fraction regimen, the PACE-B investigators modified the protocol to 62 Gy delivered in 20 fractions.

Patients assigned to SBRT received 36.25 Gy divided into give fractions delivered over 1-2 weeks, with 40 Gy to the clinical target volume.

The primary outcome was noninferiority of SBRT, measured as whether patients remained free of biochemical clinical failure. Biochemical clinical failure was defined as evidence that the cancer was returning, such as an increase in PSA levels or distant metastases or death from prostate cancer.

At a median follow-up of 73.1 months, 5-year event-free survival rates were 94.6% for patients who received conventional radiation therapy and 95.8% for patients who received SBRT, meeting the prespecified criteria for noninferiority of SBRT (P = .007).

Freedom from biochemical and clinical failure, the trial’s primary endpoint, “was significantly better on both arms than our original power calculation, where we expected control rates of approximately 85%,” Dr. Van As said in an ASTRO plenary session.

Toxicity rates were also low in both study arms. The rate of grade 2 or greater urogenital side effects at 5 years was 5.5% in the SBRT arm and 3.2% in the conventional therapy arm. Grade 2 or greater gastrointestinal side effects occurred in only two patients, one in each study arm.

Given the findings, “I think it’s now imperative that our surgeons discuss this data with their patients before they perform prostatectomies,” Dr. Van As said.

Neha Vapiwala, MD, president-elect of ASTRO who moderated a media briefing where Dr. Van As summarized the PACE-B data, commented that “this study was conducted very rigorously, with excellent quality assurance.”

The study also highlights that clinicians in the United States have considerable catching up to do, said Dr. Vapiwala, from the Hospital of the University of Pennsylvania, Philadelphia.

In the United States, “we are way behind our colleagues on the other side of the pond,” she said. “We are way behind in our uptake of ultra-hypofractionated radiation [such as SBRT], and I do believe that some of that comes from the lack of feeling comfortable with the techniques that are needed and the expertise that is needed.”

PACE-B was funded by Accuray. Dr. Van As disclosed research grants from the company and consulting fees from Varian. Dr. Berlin reported no conflict of interest relevant to the study. Dr. Vapiwala has disclosed a consulting or advisory role with Bayer.

A version of this article first appeared on Medscape.com.

SAN DIEGO – With just five fractions of stereotactic body radiation therapy (SBRT), men with low- or intermediate-risk prostate cancer can have 5-year disease control as good as that provided by conventional external-beam radiation therapy delivered at higher doses in 20-39 fractions, according to new data from the phase 3 randomized PACE-B trial.

Overall, the 5-year event-free survival rates were 95.8% among patients who received SBRT and 94.6% among those who had conventional radiation. The incidence of adverse events was also low in both groups, with no significant differences observed between the trial arms.

The similar event-free survival and toxicity profiles in both groups provide more support for SBRT, which treats prostate cancer with larger radiation fractions over a shorter time period.

“I think we can also say now with a high level of confidence that SBRT can be considered a new standard of care for low and favorable intermediate-risk prostate cancer,” said Nicholas van As, MD, MB, from the Royal Marsden NHS Foundation Trust and Institute of Cancer Research in London, who presented efficacy and safety results from the noninferiority trial at the American Society for Radiation Oncology (ASTRO) annual meeting. SBRT is more convenient for patients and more cost-effective for health care providers, Dr. Van As added.

Invited discussant Alejandro Berlin, MD, MSc, from Princess Margaret Cancer Centre and the University of Toronto, agreed “that this should be a standard of care for low and favorable intermediate-risk prostate cancer,” an option already endorsed by relevant guidelines.

But, Dr. Berlin noted, SBRT requires careful attention to technique to achieve the desired results. Further research will be needed to identify and potentially reduce variability among radiation oncology practice regarding margins, dosimetry goals, dose heterogeneity, treatment schedules, and other factors, he said.
 

An international trial

PACE-B is one of three branches of a multi-center collaboration among 37 radiation therapy centers in the United Kingdom, Ireland, and Canada.

In the trial, investigators enrolled 874 patients with T1c or T2c prostate cancer, Gleason score of 3+4 or less, prostate-specific antigen (PSA) level no higher than 20 ng/mL, MRI staging, and no prior androgen deprivation therapy. Investigators then randomly assigned them on a 1:1 basis to receive either conventional radiation (n = 441) or SBRT (n = 433).

At the start of the trial, patients who were assigned to the conventional radiation group received 78 Gy in 39 fractions over 4-8 weeks. However, after results from the CHHiP trial, which showed that a 60-Gy, 20-fraction regimen was not inferior to a 74-Gy, 37-fraction regimen, the PACE-B investigators modified the protocol to 62 Gy delivered in 20 fractions.

Patients assigned to SBRT received 36.25 Gy divided into give fractions delivered over 1-2 weeks, with 40 Gy to the clinical target volume.

The primary outcome was noninferiority of SBRT, measured as whether patients remained free of biochemical clinical failure. Biochemical clinical failure was defined as evidence that the cancer was returning, such as an increase in PSA levels or distant metastases or death from prostate cancer.

At a median follow-up of 73.1 months, 5-year event-free survival rates were 94.6% for patients who received conventional radiation therapy and 95.8% for patients who received SBRT, meeting the prespecified criteria for noninferiority of SBRT (P = .007).

Freedom from biochemical and clinical failure, the trial’s primary endpoint, “was significantly better on both arms than our original power calculation, where we expected control rates of approximately 85%,” Dr. Van As said in an ASTRO plenary session.

Toxicity rates were also low in both study arms. The rate of grade 2 or greater urogenital side effects at 5 years was 5.5% in the SBRT arm and 3.2% in the conventional therapy arm. Grade 2 or greater gastrointestinal side effects occurred in only two patients, one in each study arm.

Given the findings, “I think it’s now imperative that our surgeons discuss this data with their patients before they perform prostatectomies,” Dr. Van As said.

Neha Vapiwala, MD, president-elect of ASTRO who moderated a media briefing where Dr. Van As summarized the PACE-B data, commented that “this study was conducted very rigorously, with excellent quality assurance.”

The study also highlights that clinicians in the United States have considerable catching up to do, said Dr. Vapiwala, from the Hospital of the University of Pennsylvania, Philadelphia.

In the United States, “we are way behind our colleagues on the other side of the pond,” she said. “We are way behind in our uptake of ultra-hypofractionated radiation [such as SBRT], and I do believe that some of that comes from the lack of feeling comfortable with the techniques that are needed and the expertise that is needed.”

PACE-B was funded by Accuray. Dr. Van As disclosed research grants from the company and consulting fees from Varian. Dr. Berlin reported no conflict of interest relevant to the study. Dr. Vapiwala has disclosed a consulting or advisory role with Bayer.

A version of this article first appeared on Medscape.com.

INTRODUCTION

Urinary bladder is an extremely rare site of extrapulmonary small cell cancer (EPSCC). Unlike small cell lung cancer (SCLC), there is no clear guideline for prophylactic cranial irradiation (PCI) for EPSCC. In this case report and literature review, we discuss small cell cancer of urinary bladder (SCCUB) and the role of PCI in SCCUB.

CASE PRESENTATION

A 74-year-old male presented with gross hematuria and an unremarkable physical examination. CT showed 1.7 cm right anterolateral bladder wall thickening. Cystoscopy revealed a 2-3 cm high-grade bladder lesion. Pathology from transurethral resection of the tumor was consistent with T1N0M0 small cell carcinoma. MRI brain and FDG-PET showed no extravesical disease. Patient received four cycles of neoadjuvant carboplatin/etoposide per his preference as he wanted to protect his hearing due to his profession followed by radical cystoprostatectomy. Post-op pathology showed clear margins. We decided to forego PCI in favor of interval surveillance with MRI and follow- up images remain negative for distant metastases.

DISCUSSION

EPSCC accounts for 2.5-5% of all SCC, very rare in male genitourinary tract. Treatment approach is derived from SCLC, guided by extent of disease and patient’s functional status. Role of PCI in EPSCC has not been clearly described, and even less evidence is available for SCCUB. From a review of eleven studies in PubMed for the role of PCI in SCCUB or EPSCC, we found that SCCUB has lower incidence of brain metastases than SCLC. One study suggested that SCCUB arises from totipotent cells in the submucosa, unlike Kulchitsky cell origin of SCLC. This difference might explain the difference in their metastatic behavior. With this background, PCI is not routinely recommended for limited- stage SCCUB. There might still be a role for PCI in extensive SCCUB with high metastatic burden. More studies are needed to update the guidelines for the role of PCI for these tumors.

CONCLUSIONS

Per this literature review, PCI is not routinely recommended for SCCUB, likely due to different cells of origin compared to SCLC. Future studies should focus on characterizing differences in their metastatic behavior and updating guidelines for PCI for SCCUB.

INTRODUCTION

Urinary bladder is an extremely rare site of extrapulmonary small cell cancer (EPSCC). Unlike small cell lung cancer (SCLC), there is no clear guideline for prophylactic cranial irradiation (PCI) for EPSCC. In this case report and literature review, we discuss small cell cancer of urinary bladder (SCCUB) and the role of PCI in SCCUB.

CASE PRESENTATION

A 74-year-old male presented with gross hematuria and an unremarkable physical examination. CT showed 1.7 cm right anterolateral bladder wall thickening. Cystoscopy revealed a 2-3 cm high-grade bladder lesion. Pathology from transurethral resection of the tumor was consistent with T1N0M0 small cell carcinoma. MRI brain and FDG-PET showed no extravesical disease. Patient received four cycles of neoadjuvant carboplatin/etoposide per his preference as he wanted to protect his hearing due to his profession followed by radical cystoprostatectomy. Post-op pathology showed clear margins. We decided to forego PCI in favor of interval surveillance with MRI and follow- up images remain negative for distant metastases.

DISCUSSION

EPSCC accounts for 2.5-5% of all SCC, very rare in male genitourinary tract. Treatment approach is derived from SCLC, guided by extent of disease and patient’s functional status. Role of PCI in EPSCC has not been clearly described, and even less evidence is available for SCCUB. From a review of eleven studies in PubMed for the role of PCI in SCCUB or EPSCC, we found that SCCUB has lower incidence of brain metastases than SCLC. One study suggested that SCCUB arises from totipotent cells in the submucosa, unlike Kulchitsky cell origin of SCLC. This difference might explain the difference in their metastatic behavior. With this background, PCI is not routinely recommended for limited- stage SCCUB. There might still be a role for PCI in extensive SCCUB with high metastatic burden. More studies are needed to update the guidelines for the role of PCI for these tumors.

CONCLUSIONS

Per this literature review, PCI is not routinely recommended for SCCUB, likely due to different cells of origin compared to SCLC. Future studies should focus on characterizing differences in their metastatic behavior and updating guidelines for PCI for SCCUB.

INTRODUCTION

Urinary bladder is an extremely rare site of extrapulmonary small cell cancer (EPSCC). Unlike small cell lung cancer (SCLC), there is no clear guideline for prophylactic cranial irradiation (PCI) for EPSCC. In this case report and literature review, we discuss small cell cancer of urinary bladder (SCCUB) and the role of PCI in SCCUB.

CASE PRESENTATION

A 74-year-old male presented with gross hematuria and an unremarkable physical examination. CT showed 1.7 cm right anterolateral bladder wall thickening. Cystoscopy revealed a 2-3 cm high-grade bladder lesion. Pathology from transurethral resection of the tumor was consistent with T1N0M0 small cell carcinoma. MRI brain and FDG-PET showed no extravesical disease. Patient received four cycles of neoadjuvant carboplatin/etoposide per his preference as he wanted to protect his hearing due to his profession followed by radical cystoprostatectomy. Post-op pathology showed clear margins. We decided to forego PCI in favor of interval surveillance with MRI and follow- up images remain negative for distant metastases.

DISCUSSION

EPSCC accounts for 2.5-5% of all SCC, very rare in male genitourinary tract. Treatment approach is derived from SCLC, guided by extent of disease and patient’s functional status. Role of PCI in EPSCC has not been clearly described, and even less evidence is available for SCCUB. From a review of eleven studies in PubMed for the role of PCI in SCCUB or EPSCC, we found that SCCUB has lower incidence of brain metastases than SCLC. One study suggested that SCCUB arises from totipotent cells in the submucosa, unlike Kulchitsky cell origin of SCLC. This difference might explain the difference in their metastatic behavior. With this background, PCI is not routinely recommended for limited- stage SCCUB. There might still be a role for PCI in extensive SCCUB with high metastatic burden. More studies are needed to update the guidelines for the role of PCI for these tumors.

CONCLUSIONS

Per this literature review, PCI is not routinely recommended for SCCUB, likely due to different cells of origin compared to SCLC. Future studies should focus on characterizing differences in their metastatic behavior and updating guidelines for PCI for SCCUB.

INTRODUCTION

Lymphadenopathy in Chronic Lymphocytic Leukemia (CLL) is a very common feature. However, sudden increase in lymphadenopathy or other symptoms like weight loss should be evaluated for possible metastatic malignancy. We describe a CLL patient with diffuse mediastinal lymphadenopathy who was diagnosed with metastatic bladder cancer without a primary bladder tumor mass on imaging.

CASE DESCRIPTION

A 60-year-old man with a 60 pack-year smoking history, alcoholic cirrhosis, and a 5-year history of stage 1 CLL presented with 3 months of progressive shortness of breath; persistent cough; chills; hemoptysis; and a steady weight loss of 35 lbs. Notably, he had no bladder symptoms. Initial labs showed leukocytosis of 35.8k with a lymphocytic predominance. Screening low-dose chest CT was positive for diffuse mediastinal lymphadenopathy. Subsequent PET/CT revealed numerous hypermetabolic lymph nodes in the neck, mediastinum, left hilum, and right periaortic abdominal region. CT Chest, Abdomen, Pelvis revealed progressive lymphadenopathy as seen in prior imaging, stable pulmonary nodules up to 4 mm in size, and splenomegaly. No distant primary sites, including of the bladder, were identified. Mediastinal lymph node biopsy confirmed metastatic poorly differentiated carcinoma with immunohistochemical staining negative for p40, p63, CK20, TTF-1, Napsin A, CDX2, CA19- 9, Calretinin, and D2-40 and positive for CK7, GATA3, Ber-EP4, and Uroplakin, supporting bladder as primary origin. Urology deferred a cystoscopy given his lack of urinary symptoms and positive biopsy and was started on Carboplatin/Gemcitabine for his metastatic disease. He was ineligible for Cisplatin given his cirrhosis and hearing impairment.

DISCUSSION

In patients with CLL, new onset mediastinal lymphadenopathy is concerning for disease progression and possible transformation to a diffuse b-cell lymphoma. However, this symptom has a broad differential, including primary lung carcinomas, sarcomas, and metastatic disease. While our patient’s PET/CT and pan-CT failed to identify a distant primary site, maintaining a low clinical suspicion for metastatic disease and doing a thorough work-up was paramount. Only through immunohistochemical staining were we able to diagnosis this patient with urothelial carcinoma.

CONCLUSIONS

Biopsy with immunohistochemical staining and maintaining a low suspicion for worsening lymphadenopathy can identify unusually presenting urothelial carcinomas in CLL patients.

INTRODUCTION

Lymphadenopathy in Chronic Lymphocytic Leukemia (CLL) is a very common feature. However, sudden increase in lymphadenopathy or other symptoms like weight loss should be evaluated for possible metastatic malignancy. We describe a CLL patient with diffuse mediastinal lymphadenopathy who was diagnosed with metastatic bladder cancer without a primary bladder tumor mass on imaging.

CASE DESCRIPTION

A 60-year-old man with a 60 pack-year smoking history, alcoholic cirrhosis, and a 5-year history of stage 1 CLL presented with 3 months of progressive shortness of breath; persistent cough; chills; hemoptysis; and a steady weight loss of 35 lbs. Notably, he had no bladder symptoms. Initial labs showed leukocytosis of 35.8k with a lymphocytic predominance. Screening low-dose chest CT was positive for diffuse mediastinal lymphadenopathy. Subsequent PET/CT revealed numerous hypermetabolic lymph nodes in the neck, mediastinum, left hilum, and right periaortic abdominal region. CT Chest, Abdomen, Pelvis revealed progressive lymphadenopathy as seen in prior imaging, stable pulmonary nodules up to 4 mm in size, and splenomegaly. No distant primary sites, including of the bladder, were identified. Mediastinal lymph node biopsy confirmed metastatic poorly differentiated carcinoma with immunohistochemical staining negative for p40, p63, CK20, TTF-1, Napsin A, CDX2, CA19- 9, Calretinin, and D2-40 and positive for CK7, GATA3, Ber-EP4, and Uroplakin, supporting bladder as primary origin. Urology deferred a cystoscopy given his lack of urinary symptoms and positive biopsy and was started on Carboplatin/Gemcitabine for his metastatic disease. He was ineligible for Cisplatin given his cirrhosis and hearing impairment.

DISCUSSION

In patients with CLL, new onset mediastinal lymphadenopathy is concerning for disease progression and possible transformation to a diffuse b-cell lymphoma. However, this symptom has a broad differential, including primary lung carcinomas, sarcomas, and metastatic disease. While our patient’s PET/CT and pan-CT failed to identify a distant primary site, maintaining a low clinical suspicion for metastatic disease and doing a thorough work-up was paramount. Only through immunohistochemical staining were we able to diagnosis this patient with urothelial carcinoma.

CONCLUSIONS

Biopsy with immunohistochemical staining and maintaining a low suspicion for worsening lymphadenopathy can identify unusually presenting urothelial carcinomas in CLL patients.

INTRODUCTION

Lymphadenopathy in Chronic Lymphocytic Leukemia (CLL) is a very common feature. However, sudden increase in lymphadenopathy or other symptoms like weight loss should be evaluated for possible metastatic malignancy. We describe a CLL patient with diffuse mediastinal lymphadenopathy who was diagnosed with metastatic bladder cancer without a primary bladder tumor mass on imaging.

CASE DESCRIPTION

A 60-year-old man with a 60 pack-year smoking history, alcoholic cirrhosis, and a 5-year history of stage 1 CLL presented with 3 months of progressive shortness of breath; persistent cough; chills; hemoptysis; and a steady weight loss of 35 lbs. Notably, he had no bladder symptoms. Initial labs showed leukocytosis of 35.8k with a lymphocytic predominance. Screening low-dose chest CT was positive for diffuse mediastinal lymphadenopathy. Subsequent PET/CT revealed numerous hypermetabolic lymph nodes in the neck, mediastinum, left hilum, and right periaortic abdominal region. CT Chest, Abdomen, Pelvis revealed progressive lymphadenopathy as seen in prior imaging, stable pulmonary nodules up to 4 mm in size, and splenomegaly. No distant primary sites, including of the bladder, were identified. Mediastinal lymph node biopsy confirmed metastatic poorly differentiated carcinoma with immunohistochemical staining negative for p40, p63, CK20, TTF-1, Napsin A, CDX2, CA19- 9, Calretinin, and D2-40 and positive for CK7, GATA3, Ber-EP4, and Uroplakin, supporting bladder as primary origin. Urology deferred a cystoscopy given his lack of urinary symptoms and positive biopsy and was started on Carboplatin/Gemcitabine for his metastatic disease. He was ineligible for Cisplatin given his cirrhosis and hearing impairment.

DISCUSSION

In patients with CLL, new onset mediastinal lymphadenopathy is concerning for disease progression and possible transformation to a diffuse b-cell lymphoma. However, this symptom has a broad differential, including primary lung carcinomas, sarcomas, and metastatic disease. While our patient’s PET/CT and pan-CT failed to identify a distant primary site, maintaining a low clinical suspicion for metastatic disease and doing a thorough work-up was paramount. Only through immunohistochemical staining were we able to diagnosis this patient with urothelial carcinoma.

CONCLUSIONS

Biopsy with immunohistochemical staining and maintaining a low suspicion for worsening lymphadenopathy can identify unusually presenting urothelial carcinomas in CLL patients.

Findings from two recent studies could signal a paradigm shift in the way men are screened for prostate cancer.

In the ReIMAGINE study, a group of researchers from the United Kingdom found that half of men with apparently “safe” levels of prostate-specific antigen (PSA) below 3 ng/mL had clinically significant prostate cancers when multiparametric MRI was added to screening. The researchers, whose paper appeared in BMJ Oncology, also found that one in six screened men had a prostate lesion on MRI. 

Meanwhile, a large Swedish population-based study, published in JAMA Network Open, showed that pre-biopsy MRIs combined with PSA testing after adoption of guidelines recommending MRIs led to a decrease in the proportion of men with negative biopsies (28% to 7%) and the number of Gleason score 6 cancers (24% to 6%), while the proportion of Gleason score 7-10 cancers rose from 49% to 86%.

Researchers compared prostate MRI uptake rates in the Jönköping Region in southern Sweden over 9 years – 2011 through 2018 before prostate MRIs were recommended nationally, and 2018-2020 when MRIs became commonly used.

David Robinson, MD, PhD, associate professor at Linköping University and leader of the Swedish study, told this news organization: “MRI is now standard for men before biopsy” in that country. In Sweden, which has a high rate of mortality from prostate cancer – about 50 deaths per 100,000 men vs. 12 and 8 per 100,000 in the United Kingdom and United States, respectively – PSA testing is not routine. “Most men that are diagnosed with prostate cancer have no symptoms. They have asked for a PSA when they have visited their general practitioner,” Dr. Robinson said. “To take a PSA test is not encouraged but it is not discouraged either. It is up to each man to decide.”

PSA screening is not common in the United Kingdom. Caroline Moore, MD, chair of urology at University College London and principal investigator on ReIMAGINE, said only 20% of UK men older than age 50 undergo PSA tests because doctors in the United Kingdom are concerned about the sort of overdiagnosis and overtreatment of prostate cancer that has occurred in the United States since the mid-1990s, when PSA screening was adopted here.

The rate of PSA screening in the United States has declined with controversies over recommendations for screening, though they remain above European rates: 37% in 2019, down from 47% in 2005, according to a 2022 Veterans Administration study published in JAMA Oncology.

In the UK study, Dr. Moore’s hospital-based group asked general practitioners to send letters to 2,096 men aged 50-75 years who had not been diagnosed with prostate cancer, inviting them to undergo prostate health checks combining screening with PSA and 10-minute prostate MRIs.

Of the 457 men who responded to the letters, 303 completed both screening tests. Older White men were more likely to respond, and Black men responded 20% less often.

Of the men who completed screening, 29 (9.6%) were diagnosed with clinically significant cancer and 3 were diagnosed with clinically insignificant cancer, the researchers reported.

Dr. Moore said the PSA and MRI-first approach spared men from biopsies as well as the downsides of active surveillance, which include close monitoring with urology visits and occasional MRIs or biopsies over many years. Biopsies are considered undesirable because of pain and the risk for sepsis and other infections associated with transrectal biopsies.

But urologists in America were less convinced by the international data. William J. Catalona, MD, a urologist at Northwestern University in Chicago, who developed the PSA screening test in the 1990s, said he wasn’t surprised so many men in ReIMAGINE with low PSAs had advanced cancers. “Some of the most aggressive prostate cancers occur in men with a low PSA level – not new news,” he said.

Dr. Catalona also disagreed with the UK researchers’ emphasis on MRIs because the readings often are incorrect. A 2021 study in Prostate Cancer and Prostatic Diseases reported that multiparametric MRI had a false-negative rate of between 10% and 20%.

“MRI alone should not be considered more reliable than PSA. Rather, it should be considered complementary,” he said.

Michael S. Leapman, MD, MHS, associate professor of urology at the Yale Cancer Center, New Haven, Conn., said the UK findings point to a role for MRI as a “triage tool” to help identify men with elevated PSAs who should have a prostate biopsy.

But he said the research to date doesn’t support the use of MRI as a stand-alone test for prostate cancer. “In my opinion, it would have to demonstrate some tangible benefit to patients other than finding a greater number of cancers, such as improvement in cancer control, lower burden from the disease overall, or cancer-specific survival,” he said.

Major U.S. guidelines recommend including MRIs before biopsies. Dr. Leapman also pointed out that 2023 recommendations from the National Comprehensive Cancer Network state that MRI is “strongly recommended if available.” Yet fewer than half of U.S. urologists use MRIs as a screening tool, he said.

“My sense is that MRI is not available everywhere. We have also seen that wait times are too long in some centers, leading physicians and patients to opt for biopsy – particularly in cases with higher suspicion,” he said.

The studies from Sweden and the United Kingdom “demonstrate the strides being made in reducing overdetection of low-grade prostate cancer will increase detection of clinically significant Gleason 3+4 or higher” tumors, Dr. Leapman said. “It is unclear whether such patients in whom their otherwise low-risk disease is recast as ‘intermediate risk’ meaningfully stand to benefit in the long term from this detection.”

Dr. Robinson reported no relevant financial conflicts of interest. The Swedish Cancer Society, the Swedish Research Council, Region Jönköping, Futurum, and Clinical Cancer Research Foundation in Jönköping supported the Swedish study. Members of the ReIMAGINE study team disclosed research support from the United Kingdom’s National Institute of Health Research and various industry/other sources. The Medical Research Council and Cancer Research UK funded the ReIMAGINE study.

A version of this article appeared on Medscape.com.

Findings from two recent studies could signal a paradigm shift in the way men are screened for prostate cancer.

In the ReIMAGINE study, a group of researchers from the United Kingdom found that half of men with apparently “safe” levels of prostate-specific antigen (PSA) below 3 ng/mL had clinically significant prostate cancers when multiparametric MRI was added to screening. The researchers, whose paper appeared in BMJ Oncology, also found that one in six screened men had a prostate lesion on MRI. 

Meanwhile, a large Swedish population-based study, published in JAMA Network Open, showed that pre-biopsy MRIs combined with PSA testing after adoption of guidelines recommending MRIs led to a decrease in the proportion of men with negative biopsies (28% to 7%) and the number of Gleason score 6 cancers (24% to 6%), while the proportion of Gleason score 7-10 cancers rose from 49% to 86%.

Researchers compared prostate MRI uptake rates in the Jönköping Region in southern Sweden over 9 years – 2011 through 2018 before prostate MRIs were recommended nationally, and 2018-2020 when MRIs became commonly used.

David Robinson, MD, PhD, associate professor at Linköping University and leader of the Swedish study, told this news organization: “MRI is now standard for men before biopsy” in that country. In Sweden, which has a high rate of mortality from prostate cancer – about 50 deaths per 100,000 men vs. 12 and 8 per 100,000 in the United Kingdom and United States, respectively – PSA testing is not routine. “Most men that are diagnosed with prostate cancer have no symptoms. They have asked for a PSA when they have visited their general practitioner,” Dr. Robinson said. “To take a PSA test is not encouraged but it is not discouraged either. It is up to each man to decide.”

PSA screening is not common in the United Kingdom. Caroline Moore, MD, chair of urology at University College London and principal investigator on ReIMAGINE, said only 20% of UK men older than age 50 undergo PSA tests because doctors in the United Kingdom are concerned about the sort of overdiagnosis and overtreatment of prostate cancer that has occurred in the United States since the mid-1990s, when PSA screening was adopted here.

The rate of PSA screening in the United States has declined with controversies over recommendations for screening, though they remain above European rates: 37% in 2019, down from 47% in 2005, according to a 2022 Veterans Administration study published in JAMA Oncology.

In the UK study, Dr. Moore’s hospital-based group asked general practitioners to send letters to 2,096 men aged 50-75 years who had not been diagnosed with prostate cancer, inviting them to undergo prostate health checks combining screening with PSA and 10-minute prostate MRIs.

Of the 457 men who responded to the letters, 303 completed both screening tests. Older White men were more likely to respond, and Black men responded 20% less often.

Of the men who completed screening, 29 (9.6%) were diagnosed with clinically significant cancer and 3 were diagnosed with clinically insignificant cancer, the researchers reported.

Dr. Moore said the PSA and MRI-first approach spared men from biopsies as well as the downsides of active surveillance, which include close monitoring with urology visits and occasional MRIs or biopsies over many years. Biopsies are considered undesirable because of pain and the risk for sepsis and other infections associated with transrectal biopsies.

But urologists in America were less convinced by the international data. William J. Catalona, MD, a urologist at Northwestern University in Chicago, who developed the PSA screening test in the 1990s, said he wasn’t surprised so many men in ReIMAGINE with low PSAs had advanced cancers. “Some of the most aggressive prostate cancers occur in men with a low PSA level – not new news,” he said.

Dr. Catalona also disagreed with the UK researchers’ emphasis on MRIs because the readings often are incorrect. A 2021 study in Prostate Cancer and Prostatic Diseases reported that multiparametric MRI had a false-negative rate of between 10% and 20%.

“MRI alone should not be considered more reliable than PSA. Rather, it should be considered complementary,” he said.

Michael S. Leapman, MD, MHS, associate professor of urology at the Yale Cancer Center, New Haven, Conn., said the UK findings point to a role for MRI as a “triage tool” to help identify men with elevated PSAs who should have a prostate biopsy.

But he said the research to date doesn’t support the use of MRI as a stand-alone test for prostate cancer. “In my opinion, it would have to demonstrate some tangible benefit to patients other than finding a greater number of cancers, such as improvement in cancer control, lower burden from the disease overall, or cancer-specific survival,” he said.

Major U.S. guidelines recommend including MRIs before biopsies. Dr. Leapman also pointed out that 2023 recommendations from the National Comprehensive Cancer Network state that MRI is “strongly recommended if available.” Yet fewer than half of U.S. urologists use MRIs as a screening tool, he said.

“My sense is that MRI is not available everywhere. We have also seen that wait times are too long in some centers, leading physicians and patients to opt for biopsy – particularly in cases with higher suspicion,” he said.

The studies from Sweden and the United Kingdom “demonstrate the strides being made in reducing overdetection of low-grade prostate cancer will increase detection of clinically significant Gleason 3+4 or higher” tumors, Dr. Leapman said. “It is unclear whether such patients in whom their otherwise low-risk disease is recast as ‘intermediate risk’ meaningfully stand to benefit in the long term from this detection.”

Dr. Robinson reported no relevant financial conflicts of interest. The Swedish Cancer Society, the Swedish Research Council, Region Jönköping, Futurum, and Clinical Cancer Research Foundation in Jönköping supported the Swedish study. Members of the ReIMAGINE study team disclosed research support from the United Kingdom’s National Institute of Health Research and various industry/other sources. The Medical Research Council and Cancer Research UK funded the ReIMAGINE study.

A version of this article appeared on Medscape.com.

Findings from two recent studies could signal a paradigm shift in the way men are screened for prostate cancer.

In the ReIMAGINE study, a group of researchers from the United Kingdom found that half of men with apparently “safe” levels of prostate-specific antigen (PSA) below 3 ng/mL had clinically significant prostate cancers when multiparametric MRI was added to screening. The researchers, whose paper appeared in BMJ Oncology, also found that one in six screened men had a prostate lesion on MRI. 

Meanwhile, a large Swedish population-based study, published in JAMA Network Open, showed that pre-biopsy MRIs combined with PSA testing after adoption of guidelines recommending MRIs led to a decrease in the proportion of men with negative biopsies (28% to 7%) and the number of Gleason score 6 cancers (24% to 6%), while the proportion of Gleason score 7-10 cancers rose from 49% to 86%.

Researchers compared prostate MRI uptake rates in the Jönköping Region in southern Sweden over 9 years – 2011 through 2018 before prostate MRIs were recommended nationally, and 2018-2020 when MRIs became commonly used.

David Robinson, MD, PhD, associate professor at Linköping University and leader of the Swedish study, told this news organization: “MRI is now standard for men before biopsy” in that country. In Sweden, which has a high rate of mortality from prostate cancer – about 50 deaths per 100,000 men vs. 12 and 8 per 100,000 in the United Kingdom and United States, respectively – PSA testing is not routine. “Most men that are diagnosed with prostate cancer have no symptoms. They have asked for a PSA when they have visited their general practitioner,” Dr. Robinson said. “To take a PSA test is not encouraged but it is not discouraged either. It is up to each man to decide.”

PSA screening is not common in the United Kingdom. Caroline Moore, MD, chair of urology at University College London and principal investigator on ReIMAGINE, said only 20% of UK men older than age 50 undergo PSA tests because doctors in the United Kingdom are concerned about the sort of overdiagnosis and overtreatment of prostate cancer that has occurred in the United States since the mid-1990s, when PSA screening was adopted here.

The rate of PSA screening in the United States has declined with controversies over recommendations for screening, though they remain above European rates: 37% in 2019, down from 47% in 2005, according to a 2022 Veterans Administration study published in JAMA Oncology.

In the UK study, Dr. Moore’s hospital-based group asked general practitioners to send letters to 2,096 men aged 50-75 years who had not been diagnosed with prostate cancer, inviting them to undergo prostate health checks combining screening with PSA and 10-minute prostate MRIs.

Of the 457 men who responded to the letters, 303 completed both screening tests. Older White men were more likely to respond, and Black men responded 20% less often.

Of the men who completed screening, 29 (9.6%) were diagnosed with clinically significant cancer and 3 were diagnosed with clinically insignificant cancer, the researchers reported.

Dr. Moore said the PSA and MRI-first approach spared men from biopsies as well as the downsides of active surveillance, which include close monitoring with urology visits and occasional MRIs or biopsies over many years. Biopsies are considered undesirable because of pain and the risk for sepsis and other infections associated with transrectal biopsies.

But urologists in America were less convinced by the international data. William J. Catalona, MD, a urologist at Northwestern University in Chicago, who developed the PSA screening test in the 1990s, said he wasn’t surprised so many men in ReIMAGINE with low PSAs had advanced cancers. “Some of the most aggressive prostate cancers occur in men with a low PSA level – not new news,” he said.

Dr. Catalona also disagreed with the UK researchers’ emphasis on MRIs because the readings often are incorrect. A 2021 study in Prostate Cancer and Prostatic Diseases reported that multiparametric MRI had a false-negative rate of between 10% and 20%.

“MRI alone should not be considered more reliable than PSA. Rather, it should be considered complementary,” he said.

Michael S. Leapman, MD, MHS, associate professor of urology at the Yale Cancer Center, New Haven, Conn., said the UK findings point to a role for MRI as a “triage tool” to help identify men with elevated PSAs who should have a prostate biopsy.

But he said the research to date doesn’t support the use of MRI as a stand-alone test for prostate cancer. “In my opinion, it would have to demonstrate some tangible benefit to patients other than finding a greater number of cancers, such as improvement in cancer control, lower burden from the disease overall, or cancer-specific survival,” he said.

Major U.S. guidelines recommend including MRIs before biopsies. Dr. Leapman also pointed out that 2023 recommendations from the National Comprehensive Cancer Network state that MRI is “strongly recommended if available.” Yet fewer than half of U.S. urologists use MRIs as a screening tool, he said.

“My sense is that MRI is not available everywhere. We have also seen that wait times are too long in some centers, leading physicians and patients to opt for biopsy – particularly in cases with higher suspicion,” he said.

The studies from Sweden and the United Kingdom “demonstrate the strides being made in reducing overdetection of low-grade prostate cancer will increase detection of clinically significant Gleason 3+4 or higher” tumors, Dr. Leapman said. “It is unclear whether such patients in whom their otherwise low-risk disease is recast as ‘intermediate risk’ meaningfully stand to benefit in the long term from this detection.”

Dr. Robinson reported no relevant financial conflicts of interest. The Swedish Cancer Society, the Swedish Research Council, Region Jönköping, Futurum, and Clinical Cancer Research Foundation in Jönköping supported the Swedish study. Members of the ReIMAGINE study team disclosed research support from the United Kingdom’s National Institute of Health Research and various industry/other sources. The Medical Research Council and Cancer Research UK funded the ReIMAGINE study.

A version of this article appeared on Medscape.com.

PURPOSE

This project aims to describe the demographics of Veterans diagnosed with breast and gynecologic cancers and assess differences compared to the general population.

BACKGROUND

With an increasing number of women Veterans enrolling in the VA, it is crucial for oncologists to be prepared to provide care for VeterS32 • SEPTEMBER 2023 www.mdedge.com/fedprac/avaho NOTES ans diagnosed with breast and gynecologic cancers. Despite the rising incidence of these cancers among Veterans, there is limited characterization of the demographic profile of this population. Understanding the unique characteristics of Veterans with these malignancies, distinct from the general population, is essential for the Veterans Administration (VA) to develop programs and enhance care for these patients.

METHODS/DATA ANALYSIS

Consult records from the VA Corporate Data Warehouse between January 1, 2021, and December 31, 2022, were analyzed to identify Veterans with newly diagnosed breast, uterine, ovarian, cervical, and vulvovaginal cancer. Demographic were evaluated. Data on the general population were obtained data from SEER (Surveillance, Epidemiology, and End Results) 19 database for 2020.

RESULTS

A total of 3,304 Veterans diagnosed with breast cancer and 918 Veterans with gynecologic cancers were identified (uterine, n = 365; cervical, n = 344, ovarian, n = 177; vulvovaginal, n = 32). Veterans were found to be younger than the general population, with a mean age at diagnosis of 59 for Veterans with breast cancer to 63 for non-veterans. Among those with gynecologic cancers, the mean age at diagnosis for Veterans was 55 compared to 61 for non-veterans. Male breast cancer cases were more prevalent among Veterans, accounting for 11% in the VA compared to 1% in SEER. The Veteran cohort also displayed a higher proportion of Black patients, with 30% of breast cancer cases in the VA being Black compared to 12% in SEER.

CONCLUSIONS/IMPLICATIONS

Veterans diagnosed with breast and gynecologic cancers exhibit unique demographic characteristics compared to the general population. They tend to be younger and have a higher representation of Black patients. The incidence of male breast cancer is notably higher among Veterans. As the prevalence of these cancer types continue to rise among Veterans, it is vital for oncologists to be aware of and adequately address the unique health needs of this population. These findings emphasize the importance of tailored strategies and programs to provide optimal care for Veterans with breast and gynecologic cancers.

PURPOSE

This project aims to describe the demographics of Veterans diagnosed with breast and gynecologic cancers and assess differences compared to the general population.

BACKGROUND

With an increasing number of women Veterans enrolling in the VA, it is crucial for oncologists to be prepared to provide care for VeterS32 • SEPTEMBER 2023 www.mdedge.com/fedprac/avaho NOTES ans diagnosed with breast and gynecologic cancers. Despite the rising incidence of these cancers among Veterans, there is limited characterization of the demographic profile of this population. Understanding the unique characteristics of Veterans with these malignancies, distinct from the general population, is essential for the Veterans Administration (VA) to develop programs and enhance care for these patients.

METHODS/DATA ANALYSIS

Consult records from the VA Corporate Data Warehouse between January 1, 2021, and December 31, 2022, were analyzed to identify Veterans with newly diagnosed breast, uterine, ovarian, cervical, and vulvovaginal cancer. Demographic were evaluated. Data on the general population were obtained data from SEER (Surveillance, Epidemiology, and End Results) 19 database for 2020.

RESULTS

A total of 3,304 Veterans diagnosed with breast cancer and 918 Veterans with gynecologic cancers were identified (uterine, n = 365; cervical, n = 344, ovarian, n = 177; vulvovaginal, n = 32). Veterans were found to be younger than the general population, with a mean age at diagnosis of 59 for Veterans with breast cancer to 63 for non-veterans. Among those with gynecologic cancers, the mean age at diagnosis for Veterans was 55 compared to 61 for non-veterans. Male breast cancer cases were more prevalent among Veterans, accounting for 11% in the VA compared to 1% in SEER. The Veteran cohort also displayed a higher proportion of Black patients, with 30% of breast cancer cases in the VA being Black compared to 12% in SEER.

CONCLUSIONS/IMPLICATIONS

Veterans diagnosed with breast and gynecologic cancers exhibit unique demographic characteristics compared to the general population. They tend to be younger and have a higher representation of Black patients. The incidence of male breast cancer is notably higher among Veterans. As the prevalence of these cancer types continue to rise among Veterans, it is vital for oncologists to be aware of and adequately address the unique health needs of this population. These findings emphasize the importance of tailored strategies and programs to provide optimal care for Veterans with breast and gynecologic cancers.

PURPOSE

This project aims to describe the demographics of Veterans diagnosed with breast and gynecologic cancers and assess differences compared to the general population.

BACKGROUND

With an increasing number of women Veterans enrolling in the VA, it is crucial for oncologists to be prepared to provide care for VeterS32 • SEPTEMBER 2023 www.mdedge.com/fedprac/avaho NOTES ans diagnosed with breast and gynecologic cancers. Despite the rising incidence of these cancers among Veterans, there is limited characterization of the demographic profile of this population. Understanding the unique characteristics of Veterans with these malignancies, distinct from the general population, is essential for the Veterans Administration (VA) to develop programs and enhance care for these patients.

METHODS/DATA ANALYSIS

Consult records from the VA Corporate Data Warehouse between January 1, 2021, and December 31, 2022, were analyzed to identify Veterans with newly diagnosed breast, uterine, ovarian, cervical, and vulvovaginal cancer. Demographic were evaluated. Data on the general population were obtained data from SEER (Surveillance, Epidemiology, and End Results) 19 database for 2020.

RESULTS

A total of 3,304 Veterans diagnosed with breast cancer and 918 Veterans with gynecologic cancers were identified (uterine, n = 365; cervical, n = 344, ovarian, n = 177; vulvovaginal, n = 32). Veterans were found to be younger than the general population, with a mean age at diagnosis of 59 for Veterans with breast cancer to 63 for non-veterans. Among those with gynecologic cancers, the mean age at diagnosis for Veterans was 55 compared to 61 for non-veterans. Male breast cancer cases were more prevalent among Veterans, accounting for 11% in the VA compared to 1% in SEER. The Veteran cohort also displayed a higher proportion of Black patients, with 30% of breast cancer cases in the VA being Black compared to 12% in SEER.

CONCLUSIONS/IMPLICATIONS

Veterans diagnosed with breast and gynecologic cancers exhibit unique demographic characteristics compared to the general population. They tend to be younger and have a higher representation of Black patients. The incidence of male breast cancer is notably higher among Veterans. As the prevalence of these cancer types continue to rise among Veterans, it is vital for oncologists to be aware of and adequately address the unique health needs of this population. These findings emphasize the importance of tailored strategies and programs to provide optimal care for Veterans with breast and gynecologic cancers.

OBJECTIVE

UroNav MRI/TRUS biopsy offers a more accurate test result regarding prostate cancer. The goal of the UroNav is to find more transitional zone prostate cancers that a standard mapping biopsy is unable to see. This paper aims to evaluate the utility of UroNav MRI/TRUS biopsy to detect clinically significant transition zone cancers in patients on active surveillance with low volume, low grade cancer.

METHODS

We retrospectively analyzed 268 prostate cancer patients from Minnesota Urology over a threeyear period who underwent a UroNav (MRI/TRUS) biopsy as part of standardized follow up in an active surveillance protocol. All patients underwent both biopsy of MRI PiRAD lesions and a standard mapping biopsy at the time of procedure. Patients with positive PiRAD transition zone and negative mapping biopsies were identified. Kaplan-Meier, Cox Proportional Hazards test, ANOVA and Chi-Square tests were performed. Data was analyzed using IBM SPSS version 27 and statistical significance was set at α=0.05.

RESULTS

Of the 268 patients, 68 (25%) of the patients had a normal standard mapping prostate biopsies. Using UroNav technology cancer was found showing a statistically significant amount of prostate cancer in the transitional zone missed by standard mapping biopsy (P value <0.05) Out of these 68 patients 35 (51.5%) were reported to have a Gleason score ≥7 indicating clinically significant prostate cancer.

CONCLUSIONS

The use of UroNav MRI/TRUS fusion biopsy allowed detection of clinically significant transition zone cancer missed by concurrent standard mapping biopsies in an active surveillance population. This should be continually explored to get a larger sample size to see if the UroNav can also detect missed clinically significant prostate cancer at a high rate.

OBJECTIVE

UroNav MRI/TRUS biopsy offers a more accurate test result regarding prostate cancer. The goal of the UroNav is to find more transitional zone prostate cancers that a standard mapping biopsy is unable to see. This paper aims to evaluate the utility of UroNav MRI/TRUS biopsy to detect clinically significant transition zone cancers in patients on active surveillance with low volume, low grade cancer.

METHODS

We retrospectively analyzed 268 prostate cancer patients from Minnesota Urology over a threeyear period who underwent a UroNav (MRI/TRUS) biopsy as part of standardized follow up in an active surveillance protocol. All patients underwent both biopsy of MRI PiRAD lesions and a standard mapping biopsy at the time of procedure. Patients with positive PiRAD transition zone and negative mapping biopsies were identified. Kaplan-Meier, Cox Proportional Hazards test, ANOVA and Chi-Square tests were performed. Data was analyzed using IBM SPSS version 27 and statistical significance was set at α=0.05.

RESULTS

Of the 268 patients, 68 (25%) of the patients had a normal standard mapping prostate biopsies. Using UroNav technology cancer was found showing a statistically significant amount of prostate cancer in the transitional zone missed by standard mapping biopsy (P value <0.05) Out of these 68 patients 35 (51.5%) were reported to have a Gleason score ≥7 indicating clinically significant prostate cancer.

CONCLUSIONS

The use of UroNav MRI/TRUS fusion biopsy allowed detection of clinically significant transition zone cancer missed by concurrent standard mapping biopsies in an active surveillance population. This should be continually explored to get a larger sample size to see if the UroNav can also detect missed clinically significant prostate cancer at a high rate.

OBJECTIVE

UroNav MRI/TRUS biopsy offers a more accurate test result regarding prostate cancer. The goal of the UroNav is to find more transitional zone prostate cancers that a standard mapping biopsy is unable to see. This paper aims to evaluate the utility of UroNav MRI/TRUS biopsy to detect clinically significant transition zone cancers in patients on active surveillance with low volume, low grade cancer.

METHODS

We retrospectively analyzed 268 prostate cancer patients from Minnesota Urology over a threeyear period who underwent a UroNav (MRI/TRUS) biopsy as part of standardized follow up in an active surveillance protocol. All patients underwent both biopsy of MRI PiRAD lesions and a standard mapping biopsy at the time of procedure. Patients with positive PiRAD transition zone and negative mapping biopsies were identified. Kaplan-Meier, Cox Proportional Hazards test, ANOVA and Chi-Square tests were performed. Data was analyzed using IBM SPSS version 27 and statistical significance was set at α=0.05.

RESULTS

Of the 268 patients, 68 (25%) of the patients had a normal standard mapping prostate biopsies. Using UroNav technology cancer was found showing a statistically significant amount of prostate cancer in the transitional zone missed by standard mapping biopsy (P value <0.05) Out of these 68 patients 35 (51.5%) were reported to have a Gleason score ≥7 indicating clinically significant prostate cancer.

CONCLUSIONS

The use of UroNav MRI/TRUS fusion biopsy allowed detection of clinically significant transition zone cancer missed by concurrent standard mapping biopsies in an active surveillance population. This should be continually explored to get a larger sample size to see if the UroNav can also detect missed clinically significant prostate cancer at a high rate.

OBJECTIVE

Transitional zone cancers are not accounted for when using standard prostate biopsy techniques. Using MRI/Transrectal ultrasound fusion biopsy (UroNav) can more accurately diagnose transitional zone prostate cancer. The goal of this study is to evaluate 375 patients with transitional zone only cancer found on a UroNav biopsy MRI/Transrectal ultrasound fusion biopsy over a three-year period to evaluate the clinical significance of their cancer.

METHOD

We retrospectively analyzed 1500 patients that underwent a UroNav biopsy over a 3 year period. 375 of these patients had transitional zone only cancers. The patients with transitional and peripheral zone cancer were analyzed. The PIRAD scores were evaluated and the percent cancer determined for each zone. Clinically significant cancer for each zone was also determined.

RESULTS

Of the 1500 patients with a PIRAD lesion, 25% were located in the transitional zone, 36% in the peripheral zone and 39% in both transitional and peripheral zone. Cancer was detected in 40% of transitional zone only lesions, 44% of peripheral zone only lesions and 38% combined zone lesion. Clinically significant cancer was noted in 26%, 27% and 20%, respectively, for the TZ, PZ and combined zones. Kaplan- Meier, Cox Proportional Hazards test, ANOVA and Chi- Square tests were performed. Data was analyzed using IBM SPSS version 27 and statistical significance was set at α=0.05. PIRAD breakdown for transitional zone only cancers are as follows, PIRAD 3 (52% of patients): 24% cancer, 10% clinically significant PIRAD 4 (34% of patients): 43% cancer, 30% clinically significant PIRAD 5 (14% of patients): 75% cancer, 60% clinically significant

CONCLUSIONS

The use of a UroNav biopsy has been instrumental in detecting clinically significant cancers in the transitional zone that otherwise would have been missed on a standard mapping biopsy.

OBJECTIVE

Transitional zone cancers are not accounted for when using standard prostate biopsy techniques. Using MRI/Transrectal ultrasound fusion biopsy (UroNav) can more accurately diagnose transitional zone prostate cancer. The goal of this study is to evaluate 375 patients with transitional zone only cancer found on a UroNav biopsy MRI/Transrectal ultrasound fusion biopsy over a three-year period to evaluate the clinical significance of their cancer.

METHOD

We retrospectively analyzed 1500 patients that underwent a UroNav biopsy over a 3 year period. 375 of these patients had transitional zone only cancers. The patients with transitional and peripheral zone cancer were analyzed. The PIRAD scores were evaluated and the percent cancer determined for each zone. Clinically significant cancer for each zone was also determined.

RESULTS

Of the 1500 patients with a PIRAD lesion, 25% were located in the transitional zone, 36% in the peripheral zone and 39% in both transitional and peripheral zone. Cancer was detected in 40% of transitional zone only lesions, 44% of peripheral zone only lesions and 38% combined zone lesion. Clinically significant cancer was noted in 26%, 27% and 20%, respectively, for the TZ, PZ and combined zones. Kaplan- Meier, Cox Proportional Hazards test, ANOVA and Chi- Square tests were performed. Data was analyzed using IBM SPSS version 27 and statistical significance was set at α=0.05. PIRAD breakdown for transitional zone only cancers are as follows, PIRAD 3 (52% of patients): 24% cancer, 10% clinically significant PIRAD 4 (34% of patients): 43% cancer, 30% clinically significant PIRAD 5 (14% of patients): 75% cancer, 60% clinically significant

CONCLUSIONS

The use of a UroNav biopsy has been instrumental in detecting clinically significant cancers in the transitional zone that otherwise would have been missed on a standard mapping biopsy.

OBJECTIVE

Transitional zone cancers are not accounted for when using standard prostate biopsy techniques. Using MRI/Transrectal ultrasound fusion biopsy (UroNav) can more accurately diagnose transitional zone prostate cancer. The goal of this study is to evaluate 375 patients with transitional zone only cancer found on a UroNav biopsy MRI/Transrectal ultrasound fusion biopsy over a three-year period to evaluate the clinical significance of their cancer.

METHOD

We retrospectively analyzed 1500 patients that underwent a UroNav biopsy over a 3 year period. 375 of these patients had transitional zone only cancers. The patients with transitional and peripheral zone cancer were analyzed. The PIRAD scores were evaluated and the percent cancer determined for each zone. Clinically significant cancer for each zone was also determined.

RESULTS

Of the 1500 patients with a PIRAD lesion, 25% were located in the transitional zone, 36% in the peripheral zone and 39% in both transitional and peripheral zone. Cancer was detected in 40% of transitional zone only lesions, 44% of peripheral zone only lesions and 38% combined zone lesion. Clinically significant cancer was noted in 26%, 27% and 20%, respectively, for the TZ, PZ and combined zones. Kaplan- Meier, Cox Proportional Hazards test, ANOVA and Chi- Square tests were performed. Data was analyzed using IBM SPSS version 27 and statistical significance was set at α=0.05. PIRAD breakdown for transitional zone only cancers are as follows, PIRAD 3 (52% of patients): 24% cancer, 10% clinically significant PIRAD 4 (34% of patients): 43% cancer, 30% clinically significant PIRAD 5 (14% of patients): 75% cancer, 60% clinically significant

CONCLUSIONS

The use of a UroNav biopsy has been instrumental in detecting clinically significant cancers in the transitional zone that otherwise would have been missed on a standard mapping biopsy.

BACKGROUND

Prostate cancer is one of the most common oncologic diagnoses in VA. Follow-up after radiation treatment involves PSA lab work and a provider visit every 6 months to evaluate for recurrence and longterm side effects. This requires a large amount of VA resources in terms of staff time and can lead to reduced provider access and increased outsourcing costs. If the veteran has in person appointments, this also increases time and travel costs for the veteran.

METHODS

The Cleveland VA Radiation Oncology department has designed a novel Prostate Cancer Tracker to monitor veterans for prostate cancer follow-up. The novel workflow uses a combination of data analysis and sorting techniques along with a dedicated clinical team to triage patients to (1) direct counseling for biochemical recurrence or (2) continued follow-up through the tracker. This process improves resource utilization, efficiently tracks patients, and reduces the risk of a patient lost to follow-up. The program started in August 2022 and has been running in a pilot phase until January 2023. Patient statistics using VA analytics were collected for January 2023 to March 2023.

RESULTS

At the end of March 2023, the tracker contained 250 patients. 56 veterans had their lab work coordinated with PCP labs to avoid unnecessary needle sticks. 50 letters for overdue labs were sent out of which 31 resulted in returning to standard of care follow up. 6 patients were converted from the tracker to in person for counseling regarding biochemical recurrence. The number of in person appointments saved was 80 per month, resulting in better access for providers and savings for veterans for miles driven and veteran’s time. In addition, we have reduced outsourcing costs by re-capturing outsourced veterans back to VA for prostate cancer follow-up.

CONCLUSIONS

The prostate cancer tracker workflow is a novel workflow that has had a successful pilot as a VA iNET seed investee. We plan to expand its use within our department and further quantify improvements for the VA. We are actively looking to expand to other VA sites.

BACKGROUND

Prostate cancer is one of the most common oncologic diagnoses in VA. Follow-up after radiation treatment involves PSA lab work and a provider visit every 6 months to evaluate for recurrence and longterm side effects. This requires a large amount of VA resources in terms of staff time and can lead to reduced provider access and increased outsourcing costs. If the veteran has in person appointments, this also increases time and travel costs for the veteran.

METHODS

The Cleveland VA Radiation Oncology department has designed a novel Prostate Cancer Tracker to monitor veterans for prostate cancer follow-up. The novel workflow uses a combination of data analysis and sorting techniques along with a dedicated clinical team to triage patients to (1) direct counseling for biochemical recurrence or (2) continued follow-up through the tracker. This process improves resource utilization, efficiently tracks patients, and reduces the risk of a patient lost to follow-up. The program started in August 2022 and has been running in a pilot phase until January 2023. Patient statistics using VA analytics were collected for January 2023 to March 2023.

RESULTS

At the end of March 2023, the tracker contained 250 patients. 56 veterans had their lab work coordinated with PCP labs to avoid unnecessary needle sticks. 50 letters for overdue labs were sent out of which 31 resulted in returning to standard of care follow up. 6 patients were converted from the tracker to in person for counseling regarding biochemical recurrence. The number of in person appointments saved was 80 per month, resulting in better access for providers and savings for veterans for miles driven and veteran’s time. In addition, we have reduced outsourcing costs by re-capturing outsourced veterans back to VA for prostate cancer follow-up.

CONCLUSIONS

The prostate cancer tracker workflow is a novel workflow that has had a successful pilot as a VA iNET seed investee. We plan to expand its use within our department and further quantify improvements for the VA. We are actively looking to expand to other VA sites.

BACKGROUND

Prostate cancer is one of the most common oncologic diagnoses in VA. Follow-up after radiation treatment involves PSA lab work and a provider visit every 6 months to evaluate for recurrence and longterm side effects. This requires a large amount of VA resources in terms of staff time and can lead to reduced provider access and increased outsourcing costs. If the veteran has in person appointments, this also increases time and travel costs for the veteran.

METHODS

The Cleveland VA Radiation Oncology department has designed a novel Prostate Cancer Tracker to monitor veterans for prostate cancer follow-up. The novel workflow uses a combination of data analysis and sorting techniques along with a dedicated clinical team to triage patients to (1) direct counseling for biochemical recurrence or (2) continued follow-up through the tracker. This process improves resource utilization, efficiently tracks patients, and reduces the risk of a patient lost to follow-up. The program started in August 2022 and has been running in a pilot phase until January 2023. Patient statistics using VA analytics were collected for January 2023 to March 2023.

RESULTS

At the end of March 2023, the tracker contained 250 patients. 56 veterans had their lab work coordinated with PCP labs to avoid unnecessary needle sticks. 50 letters for overdue labs were sent out of which 31 resulted in returning to standard of care follow up. 6 patients were converted from the tracker to in person for counseling regarding biochemical recurrence. The number of in person appointments saved was 80 per month, resulting in better access for providers and savings for veterans for miles driven and veteran’s time. In addition, we have reduced outsourcing costs by re-capturing outsourced veterans back to VA for prostate cancer follow-up.

CONCLUSIONS

The prostate cancer tracker workflow is a novel workflow that has had a successful pilot as a VA iNET seed investee. We plan to expand its use within our department and further quantify improvements for the VA. We are actively looking to expand to other VA sites.