AUA Annual Meeting 2014

ORLANDO – A single prostate specific antigen level measurement before age 60 years in the setting of opportunistic screening predicted lethal prostate cancer in later life, according to findings from a nested case-control study involving Physicians’ Health Study participants.

The findings, which confirm prior observations that midlife PSA levels predict subsequent development of lethal prostate cancer in an unscreened population – and which extend the findings to a cohort where opportunistic screening occurs, could have implications for reducing unnecessary screening, biopsy, and treatment, Dr. Mark A. Preston reported at the annual meeting of the American Urological Association.

Of 14,916 men from the randomized, controlled Physicians’ Health Study who submitted a blood specimen prior to enrollment, 234 with total PSA levels available prior to age 60 years had prostate cancer diagnosed between 1983 and 1993, and 711 served as age-matched controls.

As of follow-up through 2012, metastatic or fatal disease had developed in 60 case patients.

"We went on to ask three main clinical questions about how [midlife PSA] might be clinically relevant," Dr. Preston, who is a urologist at Massachusetts General Hospital, Boston, said during a press briefing at the meeting.

The first question was whether baseline PSA predicts lethal cancer.

The median PSA levels at three age groups evaluated in the study (40-50 years, 50-55 years, and 55-60 years) were 0.68 ng/mL, 0.88 ng/mL, and 0.96 ng/mL, respectively, he said.

Using men with a PSA below the median as a reference group, the risk of lethal prostate cancer for those with PSA above the 75th percentile was "quite significant," with those aged 40-50 years having a sixfold increased risk, those aged 50-55 years having a fourfold increased risk, and those aged 55-60 having a 10-fold increased risk, he noted.

"This was even more significant for those with PSA above the 90th percentile," he said.

The next question was whether those with a very low PSA before age 60 years could forego further PSA testing.

Compared with men with a PSA above the median, those with PSA below the 25th percentile had a very low risk of lethal prostate cancer (odds ratio, 1.6), he said.

The third question was whether men with one very low PSA level measurement between ages 40-50 years could forego any further PSA testing.

"The numbers were small, but what we did find was that there were still men who had a PSA level at that very low level who still went on to die from prostate cancer at some point," he said, noting that this likely means that one PSA measurement is inadequate.

That one PSA, however, may be useful for risk stratification, allowing for a longer interval between testing for those with such low risk.

Early PSA was found in this study to have very good predictive value for lethal prostate cancer, with an area under the curve of about 0.80 for all of the age groups, he said.

"We concluded that a single baseline PSA among men at midlife strongly predicts the subsequent development of lethal prostate cancer in a U.S. population subject to opportunistic PSA screening, and also that there was no lower limit of PSA baseline at which no men developed lethal prostate cancer," he said.

The findings are notable, given the current controversy over the usefulness of PSA screening.

"The reason these data are so important – and this dovetails with a lot of other data that are out there – is that we’re trying to make a more sensible screening strategy for men," according to Dr. Scott E. Eggener, director of translational and outcomes research, section of urology at the University of Chicago, who moderated the press briefing.

This is very similar to how colonoscopy is used, he said, explaining that patients get a baseline colonoscopy and the findings determine the interval needed for follow-up.

"We’ve never done that in PSA screening for prostate cancer. It has always started at a certain age, everyone is treated the same way, it’s done once a year (at least in the United States)," he said.

The current data, when considered in light of other similar studies, are very compelling in that they demonstrate the need for a more individualized, tailored approach to screening based on factors such as race, family history, age, and baseline PSA.

"These data suggest that baseline PSA is an incredibly powerful predictor of events that are maybe destined to happen 10 or 20 years down the road, and we need to incorporate that in our thinking about screening," Dr. Eggener said.

Dr. Preston reported having no disclosures. Dr. Eggener has been a consultant, adviser, lecturer, investigator, and/or proctor for Genomic Health, Intuitive Surgical Janssen Pharmaceuticals, and Myriad Genetics.

ORLANDO – A single prostate specific antigen level measurement before age 60 years in the setting of opportunistic screening predicted lethal prostate cancer in later life, according to findings from a nested case-control study involving Physicians’ Health Study participants.

The findings, which confirm prior observations that midlife PSA levels predict subsequent development of lethal prostate cancer in an unscreened population – and which extend the findings to a cohort where opportunistic screening occurs, could have implications for reducing unnecessary screening, biopsy, and treatment, Dr. Mark A. Preston reported at the annual meeting of the American Urological Association.

Of 14,916 men from the randomized, controlled Physicians’ Health Study who submitted a blood specimen prior to enrollment, 234 with total PSA levels available prior to age 60 years had prostate cancer diagnosed between 1983 and 1993, and 711 served as age-matched controls.

As of follow-up through 2012, metastatic or fatal disease had developed in 60 case patients.

"We went on to ask three main clinical questions about how [midlife PSA] might be clinically relevant," Dr. Preston, who is a urologist at Massachusetts General Hospital, Boston, said during a press briefing at the meeting.

The first question was whether baseline PSA predicts lethal cancer.

The median PSA levels at three age groups evaluated in the study (40-50 years, 50-55 years, and 55-60 years) were 0.68 ng/mL, 0.88 ng/mL, and 0.96 ng/mL, respectively, he said.

Using men with a PSA below the median as a reference group, the risk of lethal prostate cancer for those with PSA above the 75th percentile was "quite significant," with those aged 40-50 years having a sixfold increased risk, those aged 50-55 years having a fourfold increased risk, and those aged 55-60 having a 10-fold increased risk, he noted.

"This was even more significant for those with PSA above the 90th percentile," he said.

The next question was whether those with a very low PSA before age 60 years could forego further PSA testing.

Compared with men with a PSA above the median, those with PSA below the 25th percentile had a very low risk of lethal prostate cancer (odds ratio, 1.6), he said.

The third question was whether men with one very low PSA level measurement between ages 40-50 years could forego any further PSA testing.

"The numbers were small, but what we did find was that there were still men who had a PSA level at that very low level who still went on to die from prostate cancer at some point," he said, noting that this likely means that one PSA measurement is inadequate.

That one PSA, however, may be useful for risk stratification, allowing for a longer interval between testing for those with such low risk.

Early PSA was found in this study to have very good predictive value for lethal prostate cancer, with an area under the curve of about 0.80 for all of the age groups, he said.

"We concluded that a single baseline PSA among men at midlife strongly predicts the subsequent development of lethal prostate cancer in a U.S. population subject to opportunistic PSA screening, and also that there was no lower limit of PSA baseline at which no men developed lethal prostate cancer," he said.

The findings are notable, given the current controversy over the usefulness of PSA screening.

"The reason these data are so important – and this dovetails with a lot of other data that are out there – is that we’re trying to make a more sensible screening strategy for men," according to Dr. Scott E. Eggener, director of translational and outcomes research, section of urology at the University of Chicago, who moderated the press briefing.

This is very similar to how colonoscopy is used, he said, explaining that patients get a baseline colonoscopy and the findings determine the interval needed for follow-up.

"We’ve never done that in PSA screening for prostate cancer. It has always started at a certain age, everyone is treated the same way, it’s done once a year (at least in the United States)," he said.

The current data, when considered in light of other similar studies, are very compelling in that they demonstrate the need for a more individualized, tailored approach to screening based on factors such as race, family history, age, and baseline PSA.

"These data suggest that baseline PSA is an incredibly powerful predictor of events that are maybe destined to happen 10 or 20 years down the road, and we need to incorporate that in our thinking about screening," Dr. Eggener said.

Dr. Preston reported having no disclosures. Dr. Eggener has been a consultant, adviser, lecturer, investigator, and/or proctor for Genomic Health, Intuitive Surgical Janssen Pharmaceuticals, and Myriad Genetics.

ORLANDO – A single prostate specific antigen level measurement before age 60 years in the setting of opportunistic screening predicted lethal prostate cancer in later life, according to findings from a nested case-control study involving Physicians’ Health Study participants.

The findings, which confirm prior observations that midlife PSA levels predict subsequent development of lethal prostate cancer in an unscreened population – and which extend the findings to a cohort where opportunistic screening occurs, could have implications for reducing unnecessary screening, biopsy, and treatment, Dr. Mark A. Preston reported at the annual meeting of the American Urological Association.

Of 14,916 men from the randomized, controlled Physicians’ Health Study who submitted a blood specimen prior to enrollment, 234 with total PSA levels available prior to age 60 years had prostate cancer diagnosed between 1983 and 1993, and 711 served as age-matched controls.

As of follow-up through 2012, metastatic or fatal disease had developed in 60 case patients.

"We went on to ask three main clinical questions about how [midlife PSA] might be clinically relevant," Dr. Preston, who is a urologist at Massachusetts General Hospital, Boston, said during a press briefing at the meeting.

The first question was whether baseline PSA predicts lethal cancer.

The median PSA levels at three age groups evaluated in the study (40-50 years, 50-55 years, and 55-60 years) were 0.68 ng/mL, 0.88 ng/mL, and 0.96 ng/mL, respectively, he said.

Using men with a PSA below the median as a reference group, the risk of lethal prostate cancer for those with PSA above the 75th percentile was "quite significant," with those aged 40-50 years having a sixfold increased risk, those aged 50-55 years having a fourfold increased risk, and those aged 55-60 having a 10-fold increased risk, he noted.

"This was even more significant for those with PSA above the 90th percentile," he said.

The next question was whether those with a very low PSA before age 60 years could forego further PSA testing.

Compared with men with a PSA above the median, those with PSA below the 25th percentile had a very low risk of lethal prostate cancer (odds ratio, 1.6), he said.

The third question was whether men with one very low PSA level measurement between ages 40-50 years could forego any further PSA testing.

"The numbers were small, but what we did find was that there were still men who had a PSA level at that very low level who still went on to die from prostate cancer at some point," he said, noting that this likely means that one PSA measurement is inadequate.

That one PSA, however, may be useful for risk stratification, allowing for a longer interval between testing for those with such low risk.

Early PSA was found in this study to have very good predictive value for lethal prostate cancer, with an area under the curve of about 0.80 for all of the age groups, he said.

"We concluded that a single baseline PSA among men at midlife strongly predicts the subsequent development of lethal prostate cancer in a U.S. population subject to opportunistic PSA screening, and also that there was no lower limit of PSA baseline at which no men developed lethal prostate cancer," he said.

The findings are notable, given the current controversy over the usefulness of PSA screening.

"The reason these data are so important – and this dovetails with a lot of other data that are out there – is that we’re trying to make a more sensible screening strategy for men," according to Dr. Scott E. Eggener, director of translational and outcomes research, section of urology at the University of Chicago, who moderated the press briefing.

This is very similar to how colonoscopy is used, he said, explaining that patients get a baseline colonoscopy and the findings determine the interval needed for follow-up.

"We’ve never done that in PSA screening for prostate cancer. It has always started at a certain age, everyone is treated the same way, it’s done once a year (at least in the United States)," he said.

The current data, when considered in light of other similar studies, are very compelling in that they demonstrate the need for a more individualized, tailored approach to screening based on factors such as race, family history, age, and baseline PSA.

"These data suggest that baseline PSA is an incredibly powerful predictor of events that are maybe destined to happen 10 or 20 years down the road, and we need to incorporate that in our thinking about screening," Dr. Eggener said.

Dr. Preston reported having no disclosures. Dr. Eggener has been a consultant, adviser, lecturer, investigator, and/or proctor for Genomic Health, Intuitive Surgical Janssen Pharmaceuticals, and Myriad Genetics.

ORLANDO – Absence of comorbidities, larger remnant kidney volume/body surface area ratio, and larger tumor diameter were significant predictors of mild renal insufficiency following radical nephrectomy, and smaller tumor diameter was a significant predictor of severe renal insufficiency in an analysis of 53 cases.

"This is the first report to identify the remnant kidney volume/body surface area (RKV/BSA) ratio as a promising predictor of post–radical nephrectomy renal functional decline," according to Dr. Takehiro Sejima, a urologist at Tottori University, Yonago, Japan, whose research was featured in an "Outstanding Posters" session at the annual meeting of the American Urological Association.

At a cutoff value of 115, the RKV/BSA ratio had 47.6% sensitivity and 79.2% specificity for predicting mild renal insufficiency using a receiver operating characteristic curve, Dr. Sejima said.

A total of 21 patients categorized as having mild renal insufficiency and 32 patients categorized as having severe renal insufficiency were included in the study. Those with severe renal insufficiency had a significantly greater extent of global glomerulosclerosis, compared with those with mild renal insufficiency. Also, cardiovascular disease events occurred in 11 patients with severe renal insufficiency during up to 122.5 months of follow-up; no cardiovascular disease events occurred in those with mild renal insufficiency, he said.

Estimated glomerular filtration rates were measured preoperatively, and at 6-12 months after radical nephrectomy in 175 patients. Those with a greater than 20% drop in estimated glomerular filtration rates were classified as having mild renal insufficiency, and those with a percentage decline above 40% were classified as having severe renal insufficiency.

"Our results provide physicians and patients with a useful predictor of renal functional outcomes preoperatively. The consideration of post–radical nephrectomy medical management for the prevention of cardiovascular disease, except in mild renal insufficiency patients, should be a future step toward improving the overall survival of post–radical nephrectomy patients," he concluded.

Dr. Sejima reported having no disclosures.

ORLANDO – Absence of comorbidities, larger remnant kidney volume/body surface area ratio, and larger tumor diameter were significant predictors of mild renal insufficiency following radical nephrectomy, and smaller tumor diameter was a significant predictor of severe renal insufficiency in an analysis of 53 cases.

"This is the first report to identify the remnant kidney volume/body surface area (RKV/BSA) ratio as a promising predictor of post–radical nephrectomy renal functional decline," according to Dr. Takehiro Sejima, a urologist at Tottori University, Yonago, Japan, whose research was featured in an "Outstanding Posters" session at the annual meeting of the American Urological Association.

At a cutoff value of 115, the RKV/BSA ratio had 47.6% sensitivity and 79.2% specificity for predicting mild renal insufficiency using a receiver operating characteristic curve, Dr. Sejima said.

A total of 21 patients categorized as having mild renal insufficiency and 32 patients categorized as having severe renal insufficiency were included in the study. Those with severe renal insufficiency had a significantly greater extent of global glomerulosclerosis, compared with those with mild renal insufficiency. Also, cardiovascular disease events occurred in 11 patients with severe renal insufficiency during up to 122.5 months of follow-up; no cardiovascular disease events occurred in those with mild renal insufficiency, he said.

Estimated glomerular filtration rates were measured preoperatively, and at 6-12 months after radical nephrectomy in 175 patients. Those with a greater than 20% drop in estimated glomerular filtration rates were classified as having mild renal insufficiency, and those with a percentage decline above 40% were classified as having severe renal insufficiency.

"Our results provide physicians and patients with a useful predictor of renal functional outcomes preoperatively. The consideration of post–radical nephrectomy medical management for the prevention of cardiovascular disease, except in mild renal insufficiency patients, should be a future step toward improving the overall survival of post–radical nephrectomy patients," he concluded.

Dr. Sejima reported having no disclosures.

ORLANDO – Absence of comorbidities, larger remnant kidney volume/body surface area ratio, and larger tumor diameter were significant predictors of mild renal insufficiency following radical nephrectomy, and smaller tumor diameter was a significant predictor of severe renal insufficiency in an analysis of 53 cases.

"This is the first report to identify the remnant kidney volume/body surface area (RKV/BSA) ratio as a promising predictor of post–radical nephrectomy renal functional decline," according to Dr. Takehiro Sejima, a urologist at Tottori University, Yonago, Japan, whose research was featured in an "Outstanding Posters" session at the annual meeting of the American Urological Association.

At a cutoff value of 115, the RKV/BSA ratio had 47.6% sensitivity and 79.2% specificity for predicting mild renal insufficiency using a receiver operating characteristic curve, Dr. Sejima said.

A total of 21 patients categorized as having mild renal insufficiency and 32 patients categorized as having severe renal insufficiency were included in the study. Those with severe renal insufficiency had a significantly greater extent of global glomerulosclerosis, compared with those with mild renal insufficiency. Also, cardiovascular disease events occurred in 11 patients with severe renal insufficiency during up to 122.5 months of follow-up; no cardiovascular disease events occurred in those with mild renal insufficiency, he said.

Estimated glomerular filtration rates were measured preoperatively, and at 6-12 months after radical nephrectomy in 175 patients. Those with a greater than 20% drop in estimated glomerular filtration rates were classified as having mild renal insufficiency, and those with a percentage decline above 40% were classified as having severe renal insufficiency.

"Our results provide physicians and patients with a useful predictor of renal functional outcomes preoperatively. The consideration of post–radical nephrectomy medical management for the prevention of cardiovascular disease, except in mild renal insufficiency patients, should be a future step toward improving the overall survival of post–radical nephrectomy patients," he concluded.

Dr. Sejima reported having no disclosures.

ORLANDO – Long-term testosterone replacement therapy was not associated with an increased risk of prostate cancer in hypogonadal men in a longitudinal registry study.

Furthermore, long-term use of injectable testosterone undecanoate did not negatively affect voiding function or residual voiding volume, Dr. Ahmad Haider and his associates reported at the annual meeting of the American Urological Association.

Of 300 registry participants with a mean age of 57.7 years who were receiving 1,000 mg of parenteral testosterone undecanoate, 5 developed prostate cancer during 6 years of follow-up, for a lower-than-expected incidence rate of 39.4/10,000 patient-years, said Dr. Haider, a urologist in private practice in Bremerhaven, Germany, whose abstract was selected as a "best abstract" at the meeting.

Testosterone levels in the registry participants increased from 9.86 nmol/L to 17 nmol/L during the observation period, and prostate volume increased from 28.34 mL to 30.72 mL. Mean prostate specific antigen levels remained fairly stable over time, increasing from 1.77 ng/mL to 2 ng/mL during follow-up; those who experienced PSA increases of greater than 4 ng/mL were further evaluated for prostate cancer, Dr. Haider said.

Tumor stage among the prostate cancer patients was pT2a in 4 patients, and pT1b in 1 patient. Gleason score was 3+3 in 4 patients, and 3+2 in 1 patient. All of the prostate cancer patients underwent radical prostatectomy.

The mean International Prostate Symptom Score (IPSS) in the registry participants decreased significantly from 6.57 to 4.21, the residual voiding volume decreased significantly from 46.78 ml to 15.85 ml, the International Index of Erectile Function (IIEF) Erectile Function domain increased significantly from 20.01 to 26.11 (out of 30) with a plateau at 36 months, the Aging Males Symptoms scale (AMS) (a quality of life measure) improve significantly from 53.43 to 17.41 within the first 2 years, and weight and waist circumference decreased progressively by 16.8 kg, and 8.94 cm, respectively.

Improvements in lipid pattern, blood pressure, and glucose homeostasis were also observed, Dr. Haider said.

Registry participants were evaluated at baseline, after 6 weeks of therapy, and every 12 weeks thereafter for up to 72 months. Ultrasound measures of prostate volume and residual voiding volume were taken at every visit or every other visit. PSA was measured and the IPSS, IIEF-EF, and AMS questionnaires were administered at every visit.

Treatment adherence was excellent.

The anthropometric and metabolic parameters were assessed because prostatic diseases are closely associated with the metabolic syndrome, Dr. Haider explained.

The findings suggest that ongoing concerns about the safety of long-term testosterone replacement therapy may be unfounded. In this study, the incidence of prostate cancer did not suggest an increased risk, Dr. Haider said.

"Also, long-term treatment with testosterone undecanoate injections did not negatively affect voiding function as measured by IPSS, or residual postvoiding volume. Erectile function was markedly and sustainably improved. Part of these effects may be a result of parallel reduction in body weight and visceral fat measured by waist circumference, and other elements of the metabolic syndrome," Dr. Haider concluded.

This study was partially funded by Bayer Pharma AG.

ORLANDO – Long-term testosterone replacement therapy was not associated with an increased risk of prostate cancer in hypogonadal men in a longitudinal registry study.

Furthermore, long-term use of injectable testosterone undecanoate did not negatively affect voiding function or residual voiding volume, Dr. Ahmad Haider and his associates reported at the annual meeting of the American Urological Association.

Of 300 registry participants with a mean age of 57.7 years who were receiving 1,000 mg of parenteral testosterone undecanoate, 5 developed prostate cancer during 6 years of follow-up, for a lower-than-expected incidence rate of 39.4/10,000 patient-years, said Dr. Haider, a urologist in private practice in Bremerhaven, Germany, whose abstract was selected as a "best abstract" at the meeting.

Testosterone levels in the registry participants increased from 9.86 nmol/L to 17 nmol/L during the observation period, and prostate volume increased from 28.34 mL to 30.72 mL. Mean prostate specific antigen levels remained fairly stable over time, increasing from 1.77 ng/mL to 2 ng/mL during follow-up; those who experienced PSA increases of greater than 4 ng/mL were further evaluated for prostate cancer, Dr. Haider said.

Tumor stage among the prostate cancer patients was pT2a in 4 patients, and pT1b in 1 patient. Gleason score was 3+3 in 4 patients, and 3+2 in 1 patient. All of the prostate cancer patients underwent radical prostatectomy.

The mean International Prostate Symptom Score (IPSS) in the registry participants decreased significantly from 6.57 to 4.21, the residual voiding volume decreased significantly from 46.78 ml to 15.85 ml, the International Index of Erectile Function (IIEF) Erectile Function domain increased significantly from 20.01 to 26.11 (out of 30) with a plateau at 36 months, the Aging Males Symptoms scale (AMS) (a quality of life measure) improve significantly from 53.43 to 17.41 within the first 2 years, and weight and waist circumference decreased progressively by 16.8 kg, and 8.94 cm, respectively.

Improvements in lipid pattern, blood pressure, and glucose homeostasis were also observed, Dr. Haider said.

Registry participants were evaluated at baseline, after 6 weeks of therapy, and every 12 weeks thereafter for up to 72 months. Ultrasound measures of prostate volume and residual voiding volume were taken at every visit or every other visit. PSA was measured and the IPSS, IIEF-EF, and AMS questionnaires were administered at every visit.

Treatment adherence was excellent.

The anthropometric and metabolic parameters were assessed because prostatic diseases are closely associated with the metabolic syndrome, Dr. Haider explained.

The findings suggest that ongoing concerns about the safety of long-term testosterone replacement therapy may be unfounded. In this study, the incidence of prostate cancer did not suggest an increased risk, Dr. Haider said.

"Also, long-term treatment with testosterone undecanoate injections did not negatively affect voiding function as measured by IPSS, or residual postvoiding volume. Erectile function was markedly and sustainably improved. Part of these effects may be a result of parallel reduction in body weight and visceral fat measured by waist circumference, and other elements of the metabolic syndrome," Dr. Haider concluded.

This study was partially funded by Bayer Pharma AG.

ORLANDO – Long-term testosterone replacement therapy was not associated with an increased risk of prostate cancer in hypogonadal men in a longitudinal registry study.

Furthermore, long-term use of injectable testosterone undecanoate did not negatively affect voiding function or residual voiding volume, Dr. Ahmad Haider and his associates reported at the annual meeting of the American Urological Association.

Of 300 registry participants with a mean age of 57.7 years who were receiving 1,000 mg of parenteral testosterone undecanoate, 5 developed prostate cancer during 6 years of follow-up, for a lower-than-expected incidence rate of 39.4/10,000 patient-years, said Dr. Haider, a urologist in private practice in Bremerhaven, Germany, whose abstract was selected as a "best abstract" at the meeting.

Testosterone levels in the registry participants increased from 9.86 nmol/L to 17 nmol/L during the observation period, and prostate volume increased from 28.34 mL to 30.72 mL. Mean prostate specific antigen levels remained fairly stable over time, increasing from 1.77 ng/mL to 2 ng/mL during follow-up; those who experienced PSA increases of greater than 4 ng/mL were further evaluated for prostate cancer, Dr. Haider said.

Tumor stage among the prostate cancer patients was pT2a in 4 patients, and pT1b in 1 patient. Gleason score was 3+3 in 4 patients, and 3+2 in 1 patient. All of the prostate cancer patients underwent radical prostatectomy.

The mean International Prostate Symptom Score (IPSS) in the registry participants decreased significantly from 6.57 to 4.21, the residual voiding volume decreased significantly from 46.78 ml to 15.85 ml, the International Index of Erectile Function (IIEF) Erectile Function domain increased significantly from 20.01 to 26.11 (out of 30) with a plateau at 36 months, the Aging Males Symptoms scale (AMS) (a quality of life measure) improve significantly from 53.43 to 17.41 within the first 2 years, and weight and waist circumference decreased progressively by 16.8 kg, and 8.94 cm, respectively.

Improvements in lipid pattern, blood pressure, and glucose homeostasis were also observed, Dr. Haider said.

Registry participants were evaluated at baseline, after 6 weeks of therapy, and every 12 weeks thereafter for up to 72 months. Ultrasound measures of prostate volume and residual voiding volume were taken at every visit or every other visit. PSA was measured and the IPSS, IIEF-EF, and AMS questionnaires were administered at every visit.

Treatment adherence was excellent.

The anthropometric and metabolic parameters were assessed because prostatic diseases are closely associated with the metabolic syndrome, Dr. Haider explained.

The findings suggest that ongoing concerns about the safety of long-term testosterone replacement therapy may be unfounded. In this study, the incidence of prostate cancer did not suggest an increased risk, Dr. Haider said.

"Also, long-term treatment with testosterone undecanoate injections did not negatively affect voiding function as measured by IPSS, or residual postvoiding volume. Erectile function was markedly and sustainably improved. Part of these effects may be a result of parallel reduction in body weight and visceral fat measured by waist circumference, and other elements of the metabolic syndrome," Dr. Haider concluded.

This study was partially funded by Bayer Pharma AG.