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Unlabelled: Study Type - Therapy (case series) Level of Evidence 4. What's known on the subject? and What does the study add? Although phosphodiesterase inhibitor use post radical prostatectomy improves potency, little is known about its affects on sexual bother. We found no difference in sexual bother scores between patients who use and do not use phosphodiesterase inhibitors. This suggests that the current definition of potency, inclusive of medication use, is valid with respect to sexual bother., Objective: To determine whether the current definition of potency, inclusive of phosphodiesterase inhibitor (PDEi) use, is valid with respect to sexual bother (SB). This will be assessed by characterizing the effect of PDEi use on SB scores in men who are potent post radical prostatectomy., Patients and Methods: The study population consisted of patients who were potent both before and after radical prostatectomy, with at least 2 years of follow-up. Disease-specific quality of life data were evaluated by the University of California, Los Angeles, Prostate Cancer Index (PCI) survey. The relationships between changes in sexual function (SF) and SB and use of PDEi over time were evaluated by mixed model analysis controlling for age, clinical risk group, marital status, and time of PCI assessment., Results: Of the 246 patients who met the study criteria, 39% reported PDEi use at some point after treatment. PDEi use was not associated with improved SF (P= 0.81). Furthermore, PDEi use was not associated with a change in SB (P= 0.36). Both SF and SB were significantly associated with time of assessment and age, and SF and SB each improved over time. In addition, SB was significantly associated with marital status., Conclusions: In this analysis, there was no difference in SF scores between men who were potent with or without the use of PDEi. Furthermore, there was no difference in SB scores between men who were potent with or without the use of PDEi. This suggests that the current, inclusive, definition of potency is valid with respect to SB., (© 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL.)

Context: Sexual function is the health-related quality of life (HRQOL) domain most commonly impaired after prostate cancer treatment; however, validated tools to enable personalized prediction of erectile dysfunction after prostate cancer treatment are lacking., Objective: To predict long-term erectile function following prostate cancer treatment based on individual patient and treatment characteristics., Design: Pretreatment patient characteristics, sexual HRQOL, and treatment details measured in a longitudinal academic multicenter cohort (Prostate Cancer Outcomes and Satisfaction With Treatment Quality Assessment; enrolled from 2003 through 2006), were used to develop models predicting erectile function 2 years after treatment. A community-based cohort (community-based Cancer of the Prostate Strategic Urologic Research Endeavor [CaPSURE]; enrolled 1995 through 2007) externally validated model performance. Patients in US academic and community-based practices whose HRQOL was measured pretreatment (N = 1201) underwent follow-up after prostatectomy, external radiotherapy, or brachytherapy for prostate cancer. Sexual outcomes among men completing 2 years' follow-up (n = 1027) were used to develop models predicting erectile function that were externally validated among 1913 patients in a community-based cohort., Main Outcome Measures: Patient-reported functional erections suitable for intercourse 2 years following prostate cancer treatment., Results: Two years after prostate cancer treatment, 368 (37% [95% CI, 34%-40%]) of all patients and 335 (48% [95% CI, 45%-52%]) of those with functional erections prior to treatment reported functional erections; 531 (53% [95% CI, 50%-56%]) of patients without penile prostheses reported use of medications or other devices for erectile dysfunction. Pretreatment sexual HRQOL score, age, serum prostate-specific antigen level, race/ethnicity, body mass index, and intended treatment details were associated with functional erections 2 years after treatment. Multivariable logistic regression models predicting erectile function estimated 2-year function probabilities from as low as 10% or less to as high as 70% or greater depending on the individual's pretreatment patient characteristics and treatment details. The models performed well in predicting erections in external validation among CaPSURE cohort patients (areas under the receiver operating characteristic curve, 0.77 [95% CI, 0.74-0.80] for prostatectomy; 0.87 [95% CI, 0.80-0.94] for external radiotherapy; and 0.90 [95% CI, 0.85-0.95] for brachytherapy)., Conclusion: Stratification by pretreatment patient characteristics and treatment details enables prediction of erectile function 2 years after prostatectomy, external radiotherapy, or brachytherapy for prostate cancer.

Objective: To quantitatively assess the effect of radical prostatectomy (RP) on the specific domains that comprise overall sexual function (SF), focusing on the relationships among these domains and overall SF, and to identify predictors for recovery of SF over time, as a decline in SF and sexual bother (SB) are known potential complications of treatment for prostate cancer., Patients and Methods: Within the Cancer of the Prostate Strategic Urologic Research Endeavor database, we identified men diagnosed between 1995 and 2001 with localized prostate cancer treated with RP. SF and SB outcomes, measured using the University of California Los Angeles Prostate Cancer Index, were assessed at 6-month intervals for 4 years after RP., Results: In all, 620 men met the study criteria; at 6 months after RP, overall and all the specific domains of SF declined, with improvement in most specific domains by 2 years after RP. The greatest declines were in the ability to achieve erections, high-quality erections, and frequent erections; these domains were also most strongly correlated with overall SF. Sexual desire was relatively preserved, and there was a weak correlation between overall SF and sexual desire after RP, when there was the greatest discrepancy between sexual desire and other domains of function. SB showed continued improvement over time to 4 years but was not well correlated with any measurements of SF assessed. Younger age, college education, sexual aid and medication use, the absence of comorbid conditions, and nerve-sparing surgery were predictive of significant recovery of function in several specific domains of SF., Conclusions: RP affects specific domains of SF to differing degrees. Compromised erectile function is most commonly reported among these specific domains and seems to play a more dominant role in determining overall SF, but notably none of the domains of function were closely linked to SB. Because education is protective in the perception of bother, appropriate counselling and the setting of expectations for outcomes in overall and specific domains of SF might lead to improved quality of life after treatment for prostate cancer., (© 2010 THE AUTHORS. JOURNAL COMPILATION © 2010 BJU INTERNATIONAL.)

Purpose: We determined whether the impact of phosphodiesterase inhibitors on sexual function and sexual bother is different after radical prostatectomy vs radiation therapy for localized prostate cancer., Materials and Methods: We analyzed data from 1,087 men treated for localized prostate cancer with radical prostatectomy or radiation therapy, who had at least 2 years of health related quality of life followup and who reported using a phosphodiesterase type 5 inhibitor after prostate cancer treatment. Sexual function and bother were assessed over time using the UCLA Prostate Cancer Index. Mixed model analysis was used to examine sexual function and sexual bother over time after initiation of treatment with a phosphodiesterase type 5 inhibitor. Response rates were then determined using the criterion of an increase in score of at least half the standard deviation in baseline scores, and multivariate logistic regression was used to identify predictors of improved sexual function and sexual bother in response to phosphodiesterase type 5 inhibitor use., Results: Patients treated with radical prostatectomy and those who received radiation therapy had an improvement in sexual function and sexual bother after initiating phosphodiesterase type 5 inhibitor use. Response rates were similar for both types of treatment, and the only significant predictors of response to phosphodiesterase type 5 inhibitors were higher baseline (pretreatment) sexual function score and lower sexual function before phosphodiesterase type 5 inhibitor use. There was no significant change in response to phosphodiesterase type 5 inhibitors over time., Conclusions: Analysis of these data suggests that choice of treatment for localized prostate cancer is unlikely to have a significant impact on response to phosphodiesterase type 5 inhibitors should they be needed after treatment. However, patients with better pretreatment sexual function are more likely to respond to phosphodiesterase type 5 inhibitors.

Background: We investigated whether androgen deprivation therapy (ADT) use is associated with an increased risk of death from cardiovascular causes in patients treated for localized prostate cancer., Methods: From the Cancer of the Prostate Strategic Urologic Research Endeavor database, data on 3262 patients treated with radical prostatectomy and 1630 patients treated with external beam radiation therapy, brachytherapy, or cryotherapy for localized prostate cancer were included in this analysis. Competing risks regression analyses were performed to assess whether use of ADT was associated with a shorter time to death from cardiovascular causes after controlling for age (as a continuous variable) and the presence of baseline cardiovascular disease risk factors. All tests for statistical significance were two-sided., Results: The median follow-up time was 3.8 years (range = 0.1-11.3 years). Among the 1015 patients who received ADT, the median duration of ADT use was 4.1 months (range = 1.0-32.9 months). In a competing risks regression analysis that controlled for age and risk factors for cardiovascular disease, both ADT use (adjusted hazard ratio [HR] = 2.6; 95% confidence interval [CI] = 1.4 to 4.7; P = .002) and age (adjusted HR = 1.07; 95% CI = 1.02 to 1.1; P = .003) were associated with statistically significantly increased risks of death from cardiovascular causes in patients treated with radical prostatectomy. Among patients 65 years or older treated with radical prostatectomy, the 5-year cumulative incidence of cardiovascular death was 5.5% (95% CI = 1.2% to 9.8%) in those who received ADT and 2.0% (95% CI = 1.1% to 3.0%) in those who did not. Among patients 65 years or older treated with external beam radiation therapy, brachytherapy, or cryotherapy, ADT use was associated with a higher cumulative incidence of death from cardiovascular causes, but the difference did not reach statistical significance., Conclusions: The use of ADT appears to be associated with an increased risk of death from cardiovascular causes in patients undergoing radical prostatectomy for localized prostate cancer.

Purpose: Improved urinary function following radical prostatectomy due to bladder outlet obstruction from subclinical benign prostatic hyperplasia has been described. We determined if prostate volume determined by preoperative transrectal ultrasound could predict recovery of urinary function and continence following radical prostatectomy., Materials and Methods: We identified all 4,984 patients who underwent radical prostatectomy in the CaPSURE national disease registry of men with prostate cancer. Only the 2,097 men who had data available on preoperative prostate volume by transrectal ultrasound, and complete preoperative and postoperative data available on urinary function using the UCLA-PCI were selected for study. Transrectal ultrasound volume was categorized as less than 25, 25 to 50 cc or greater than 50 cc. Univariate and mixed multivariate analyses were performed to determine the association between transrectal ultrasound based prostate volume and continence, as measured by urinary function scores 6 months to 2 years following radical prostatectomy. Analyses were controlled for baseline urinary function as well as other variables, such as body mass index, time of urinary function assessment and patient age at diagnosis. Total and individual item scores on the urinary function subscale were used as outcome variables in separate models., Results: Median transrectal ultrasound prostate volume was 35 cc (IQR 27-47.8). In the ANOVA for mixed models patient age, time of urinary function assessment, body mass index and transrectal ultrasound prostate volume were independent predictors of urinary continence. Patients with prostate volume greater than 50 cc had lower rates of continence, as assessed by urinary function scores 6 months and 1 year after radical prostatectomy, but scores equalized across all volume ranges by 2 years after radical prostatectomy. The individual domains most significantly affected were urinary control (p = 0.02), urine leakage during sexual activity (p = 0.0016) and urine leakage frequency (p = 0.0175)., Conclusions: These data indicate that baseline prostate volume is a predictor of recovery of urinary function after radical prostatectomy. Men with larger volume prostates have lower levels of continence up to 2 years after radical prostatectomy. A potential reason could be subclinical bladder dysfunction related to benign prostatic hyperplasia that manifests after surgery.

Purpose: Limited bilateral pelvic lymph node dissection performed at radical prostatectomy provides staging information that is used to guide further disease management. Given the effects of widespread prostate specific antigen testing and stage migration, most procedures in the United States are performed for low risk disease, which has a low probability (less than 1%) of lymph node metastasis. We compared 5-year treatment failure rates in patients with low, intermediate and high risk disease who underwent radical prostatectomy with or without pelvic lymph node dissection., Materials and Methods: We compared treatment failure rates for radical prostatectomy in 4,693 patients enrolled in the CaPSURE database who underwent radical prostatectomy with or without limited pelvic lymph node dissection. Secondary analysis was performed as a function of pelvic lymph node dissection and risk group based on pretreatment stage, grade and prostate specific antigen. Treatment failure rates were estimated by Kaplan-Meier analysis., Results: The 5-year failure-free survival rate was 70% in the no pelvic lymph node dissection group and 74% in the limited pelvic lymph node dissection group (p = 0.11), while the rates in the low, intermediate and high risk groups were 81% and 82% (p = 0.83), 71% and 63% (p = 0.21), and 42% and 48% (p = 0.45) in the no vs limited pelvic lymph node dissection groups, respectively. Multivariate analysis demonstrated that pelvic lymph node dissection status was not a predictor of treatment failure (p = 0.93)., Conclusions: This study demonstrates in a large cohort of patients that limited pelvic lymph node dissection at radical prostatectomy has no effect on treatment failure rates at 5 years in those at low, intermediate and high risk.

Purpose: Widespread screening for prostate cancer in the United States has resulted in earlier tumor identification at lower stages. The fewer number of men with lymph node metastases at initial presentation has altered patterns of pelvic lymphadenectomy before definitive treatment. We characterized patterns of pelvic lymphadenectomy in conjunction with radical prostatectomy in a community based cohort., Materials and Methods: In the CaPSURE database we identified men undergoing radical prostatectomy. Patients were stratified into 3 clinical risk groups based on serum prostate specific antigen, T stage and pathological grade. We examined temporal trends of pelvic lymphadenectomy and predictors of pelvic lymphadenectomy., Results: From 1992 to 2004 the proportion of men undergoing pelvic lymphadenectomy in conjunction with radical prostatectomy decreased from 94% to 80%. Overall positive lymph nodes were identified in 0.87%, 2.0% and 7.1% of men in the low, intermediate and high risk groups, respectively. While men with high risk disease continued to undergo pelvic lymphadenectomy at a high rate (greater than 90%), the fraction of men at low and intermediate risk undergoing pelvic lymphadenectomy steadily decreased. Prostate specific antigen, Gleason sum, clinical stage and income were factors associated with pelvic lymphadenectomy. A mean of 5.7 lymph nodes (median 5.0) were removed., Conclusions: The performance of pelvic lymphadenectomy has decreased in patients at low and intermediate risk, and remained stable in patients at high risk. Further investigation of the role of extended pelvic lymphadenectomy and the potential therapeutic benefits of pelvic lymphadenectomy would better define the contemporary role of pelvic lymphadenectomy and identify appropriate candidates.

Objectives: To determine the association between obesity and prostate cancer recurrence after primary treatment with radical prostatectomy., Methods: Data were abstracted from CaPSURE, a disease registry of 10,018 men with prostate cancer. We included 2131 men who had undergone radical prostatectomy between 1989 and 2003 and had body mass index (BMI) information available. Recurrence was defined as two consecutive prostate-specific antigen (PSA) levels of 0.2 ng/mL or greater or any second treatment. Patients were risk stratified using the PSA level, Gleason grade, and clinical T stage., Results: Patients were followed up for a median of 23 months. Of the 2131 patients, 251 (12%) developed recurrence at a median of 13 months (range 1 to 107); 183 (9%) of these men had PSA failure and 68 (3%) received a second treatment. After adjusting for risk group, ethnicity, age, and comorbidities, a significant association was found between an increasing BMI and disease recurrence (P = 0.028). Very obese patients (BMI 35 kg/m2 or more) were 1.69 times more likely to have recurrence relative to men of normal weight (BMI less than 25.0 kg/m2; 95% confidence interval [CI] 1.01 to 2.84). An increasing PSA level (P <0.0001) and Gleason grade (P <0.0001) were also associated with recurrence. Ethnicity was not significantly associated with either BMI or PSA recurrence (P = 0.685 and P = 0.068, respectively)., Conclusions: The results of our study have shown that obesity is an independent predictor of prostate cancer recurrence. Because of the increased comorbidities and greater rates of recurrence, obese individuals undergoing radical prostatectomy need vigilant follow-up care.

Purpose: Health related quality of life (HRQOL) is an important measure of outcomes among patients with prostate cancer due to disease related and treatment related effects on physical and emotional health. We determined if there are differences in the HRQOL of obese men at diagnosis and after radical prostatectomy compared to the HRQOL of men with normal body mass index (BMI)., Materials and Methods: Data were abstracted from Cancer of the Prostate Strategic Urological Research Endeavor (CaPSURE), a disease registry of 10,018 men with prostate cancer. A total of 1,884 men were included in study who were treated with radical prostatectomy between 1989 and 2002, had BMI information available and had completed 1 initial HRQOL questionnaire. Of these men 672 who completed at least 2 followup questionnaires were assessed further., Results: The BMI (kg/m) distributions were 24% normal (less than 24.9 kg/m), 56% overweight (25 to 29.9), 16% obese (30 to 34.9) and 4% very obese (greater than 35 kg/m). Higher BMI was associated with worse physical function, bodily pain, general health, vitality and role physical, but better bowel bother at diagnosis independent of race. Higher BMI was also associated with worse HRQOL after radical prostatectomy for physical function, general health and vitality, but better bowel bother. HRQOL differences between BMI groups were similar among times for all measured variables. Compared to the normal group, the higher BMI groups had similar HRQOL after radical prostatectomy., Conclusions: In the majority of domains men with higher BMI had lower HRQOL at diagnosis than men of normal BMI. Obese men have a similar recovery pattern of HRQOL after radical prostatectomy, with minimal additive long-term impairment in HRQOL relative to men of normal weight.

Purpose: Biochemical failure after definitive treatment for localized prostate cancer may occur in a substantial number of patients. The pattern and type of treatment offered to such patients have been poorly documented. We determined second treatment patterns in patients with biochemical failure following radical prostatectomy (RP)., Materials and Methods: A total of 303 patients treated with RP who had biochemical failure were identified from CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor, Tap Pharmaceutical Products, Inc., Lake Forest, Illinois), a national longitudinal registry of men with prostate cancer. Failure was defined as 2 or more prostate specific antigen (PSA) values 0.2 or greater following RP. The timing and type of secondary cancer treatment were determined. Cox proportional hazards regression analysis was conducted to determine significant predictors of time to secondary treatment, and logistic regression was used to determine predictors of the type of secondary treatment (androgen deprivation versus radiation)., Results: Of the 303 patients with biochemical failure 102 (33.7%) received second treatment a mean of 12 months after failure was documented. Second treatments were divided between androgen deprivation (57%) and radiation (43%). On multivariate analysis predictors of second treatment were clinical stage, biopsy Gleason score and PSA at failure. Patients with higher PSA at diagnosis and seminal vesicle invasion were more likely to receive androgen deprivation than radiation as second treatment., Conclusions: Second treatment timing and type after biochemical failure for patients initially treated with RP were documented. Clinical characteristics, such as PSA, Gleason score and clinical stage, can be used to determine which patients are at highest risk for second treatment after RP and can help guide subsequent treatment decisions.