Prospective Multicenter Comparison of Open and Robotic Radical Prostatectomy: The PROST-QA/RP2 Consortium.

PURPOSE: Our goal was to evaluate the comparative effectiveness of robot-assisted laparoscopic prostatectomy (RALP) and open radical prostatectomy (ORP) in a multicenter study. MATERIALS AND METHODS: We evaluated men with localized prostate cancer at 11 high-volume academic medical centers in the United States from the PROST-QA (2003-2006) and the PROST-QA/RP2 cohorts (2010-2013) with a pre-specified goal of comparing RALP (549) and ORP (545). We measured longitudinal patient-reported health-related quality of life (HRQOL) at pre-treatment and at 2, 6, 12, and 24 months, and pathological and perioperative outcomes/complications. RESULTS: Demographics, cancer characteristics, and margin status were similar between surgical approaches. ORP subjects were more likely to undergo lymphadenectomy (89% vs 47%; p <0.01) and nerve sparing (94% vs 89%; p <0.01). RALP vs ORP subjects experienced less mean intraoperative blood loss (192 vs 805 mL; p <0.01), shorter mean hospital stay (1.6 vs 2.1 days; p <0.01), and fewer blood transfusions (1% vs 4%; p <0.01), wound infections (2% vs 4%; p=0.02), other infections (1% vs 4%; p <0.01), deep venous thromboses (0.5% vs 2%; p=0.04), and bladder neck contractures requiring dilation (1.6% vs 8.3%; p <0.01). RALP subjects reported less pain (p=0.04), less activity interference (p <0.01) and higher incision satisfaction (p <0.01). Surgical approach (RALP vs ORP) was not a significant predictor of longitudinal HRQOL change in any HRQOL domain. CONCLUSIONS: In high-volume academic centers, RALP and ORP patients may expect similar long-term HRQOL outcomes. Overall, RALP patients have less pain, shorter hospital stays, and fewer post-surgical complications such as blood transfusions, infections, deep venous thromboses, and bladder neck contractures.

Effect of Intravesical Instillation of Gemcitabine vs Saline Immediately Following Resection of Suspected Low-Grade Non-Muscle-Invasive Bladder Cancer on Tumor Recurrence: SWOG S0337 Randomized Clinical Trial.

Importance: Low-grade non-muscle-invasive urothelial cancer frequently recurs after excision by transurethral resection of bladder tumor (TURBT). Objective: To determine whether immediate post-TURBT intravesical instillation of gemcitabine reduces recurrence of suspected low-grade non-muscle-invasive urothelial cancer compared with saline. Design, Setting, and Participants: Randomized double-blind clinical trial conducted at 23 US centers. Patients with suspected low-grade non-muscle-invasive urothelial cancer based on cystoscopic appearance without any high-grade or without more than 2 low-grade urothelial cancer episodes within 18 months before index TURBT were enrolled between January 23, 2008, and August 14, 2012, and followed up every 3 months with cystoscopy and cytology for 2 years and then semiannually for 2 years. Patients were monitored for tumor recurrence, progression to muscle invasion, survival, and toxic effects. The final date of follow-up was August 14, 2016. Interventions: Participants were randomly assigned to receive intravesical instillation of gemcitabine (2 g in 100 mL of saline) (n = 201) or saline (100 mL) (n = 205) for 1 hour immediately following TURBT. Main Outcomes and Measures: The primary outcome was time to recurrence of cancer. Secondary end points were time to muscle invasion and death due to any cause. Results: Among 406 randomized eligible patients (median age, 66 years; 84.7% men), 383 completed the trial. In the intention-to-treat analysis, 67 of 201 patients (4-year estimate, 35%) in the gemcitabine group and 91 of 205 patients (4-year estimate, 47%) in the saline group had cancer recurrence within 4.0 years (hazard ratio, 0.66; 95% CI, 0.48-0.90; P<.001 by 1-sided log-rank test for time to recurrence). Among the 215 patients with low-grade non-muscle-invasive urothelial cancer who underwent TURBT and drug instillation, 34 of 102 patients (4-year estimate, 34%) in the gemcitabine group and 59 of 113 patients (4-year estimate, 54%) in the saline group had cancer recurrence (hazard ratio, 0.53; 95% CI, 0.35-0.81; P = .001 by 1-sided log-rank test for time to recurrence). Fifteen patients had tumors that progressed to muscle invasion (5 in the gemcitabine group and 10 in the saline group; P = .22 by 1-sided log-rank test) and 42 died of any cause (17 in the gemcitabine group and 25 in the saline group; P = .12 by 1-sided log-rank test). There were no grade 4 or 5 adverse events and no significant differences in adverse events of grade 3 or lower. Conclusions and Relevance: Among patients with suspected low-grade non-muscle-invasive urothelial cancer, immediate postresection intravesical instillation of gemcitabine, compared with instillation of saline, significantly reduced the risk of recurrence over a median of 4.0 years. These findings support using this therapy, but further research is needed to compare gemcitabine with other intravesical agents. Trial Registration: clinicaltrials.gov Identifier: NCT00445601.

Functional Outcomes Following Nerve Sparing Prostatectomy Augmented with Seminal Vesicle Sparing Compared to Standard Nerve Sparing Prostatectomy: Results from a Randomized Controlled Trial.

PURPOSE: Seminal vesicle sparing may reduce the risk of neurovascular bundle injury and improve functional outcomes after prostatectomy. While several observational studies have shown better functional outcomes following seminal vesicle sparing approaches, evidence from randomized trials is lacking. We performed a randomized controlled trial comparing functional and cancer control outcomes between nerve sparing prostatectomy augmented with seminal vesicle sparing and standard nerve sparing prostatectomy. MATERIALS AND METHODS: A total of 140 men with early stage prostate cancer were enrolled in a randomized phase II trial comparing nerve sparing prostatectomy augmented with seminal vesicle sparing to standard nerve sparing prostatectomy. Patient reported sexual and urinary functional scores were assessed prior to surgery, and 6 and 12 months postoperatively. Surgical margin status and prostate specific antigen recurrence were evaluated as secondary outcomes. RESULTS: There were no differences in sexual or urinary function scores after surgery between the study groups. The median urinary incontinence domain score was 92 in the nerve sparing group and 87.5 in the nerve plus seminal vesicle sparing group at 12 months (p = 0.77). Median sexual function domain scores were 73.7 in the nerve sparing group and 77.1 in the nerve sparing plus seminal vesicle sparing group at 12 months (p = 0.29). Margin status and 12-month biochemical recurrence were similar in the groups. CONCLUSIONS: Recovery of continence and sexual function was similar between the groups in this randomized controlled trial. Seminal vesicle sparing did not negatively affect margin status or 12-month biochemical (prostate specific antigen) recurrence. These results suggest limited usefulness of seminal vesicle sparing prostatectomy.

Prostate capsule sparing versus nerve sparing radical cystectomy for bladder cancer: results of a randomized, controlled trial.

PURPOSE: Prostate capsule sparing and nerve sparing cystectomies are alternative procedures for bladder cancer that may decrease morbidity while achieving cancer control. However, to our knowledge the comparative effectiveness of these approaches has not been established. We evaluated functional and oncologic outcomes in patients undergoing these procedures. MATERIALS AND METHODS: We performed a single institution trial in patients with bladder cancer in whom transurethral prostatic urethral biopsy and transrectal prostate biopsy were negative. Men were randomized to prostate capsule sparing or nerve sparing cystectomy with neobladder creation and stratified by Sexual Health Inventory for Men score (greater than 21 vs 21 or less). Our primary end point was 12-month overall urinary function as measured by Bladder Cancer Index. Secondary end points included sexual function, cancer control and complications. RESULTS: A total of 40 patients were enrolled in the study with 20 patients in each arm. Urinary function at 12 months decreased by 13 and 28 points in the prostate capsule and nerve sparing groups, respectively (p = 0.10). Sexual function followed a similar pattern (p = 0.06). There was no difference in recurrence-free, metastasis-free or overall survival (each p >0.05). The rate of incidentally detected prostate cancer was similar (p = 0.15). CONCLUSIONS: Our study provides a randomized comparison of prostate capsule sparing and nerve sparing cystectomy techniques. We found no difference in functional or oncologic outcomes between the 2 approaches, although our study was underpowered due to a lack of patient accrual.

Open surgical partial nephrectomy for upper tract urothelial carcinoma.

We aimed to determine the ability of partial nephrectomy to prevent end-stage renal disease and tumor recurrence or progression in patients with upper tract urothelial carcinoma. Retrospectively, eight patients undergoing partial nephrectomy for upper tract urothelial carcinoma were identified and their medical records reviewed. All patients had imperative indications for nephron sparing, and diagnosis of upper tract urothelial carcinoma not adequately amenable to endoscopic management. Although three patients suffered acute tubular necrosis, only one required postoperative hemodialysis. During the follow-up period 25% (2/8) developed end-stage renal disease, including the one patient who had received postoperative hemodialysis. Recurrences occurred in five of seven patients with adequate oncological surveillance. Recurrences were successfully treated endoscopically in 80% (4/5) patients, and one patient had metastases. Of the eight patients, four have died. Death occurred 4 months, 1 year, 1.2 years and 3.5 years after partial nephrectomy. Of these patients, one succumbed to metastatic disease; the exact cause of death is unknown in the other three, but there was no documentation of metastatic cancer. The mean duration of follow up in the remaining four patients, all without evidence of metastatic urothelial cancer, is 71 months (range 22-108 months). In summary, partial nephrectomy for upper tract urothelial carcinoma in patients with imperative indications averts end-stage renal disease in most patients, and appears to be associated with acceptable disease-specific survival. Partial nephrectomy is a sparingly used option in patients with upper tract urothelial carcinoma refractory to endoscopic management who have imperative indications for nephron sparing.

Early postoperative urinary and sexual function predicts functional recovery 1 year after prostatectomy.

PURPOSE: Successful treatment of locally confined prostate cancer is defined by postoperative cancer control, continence and potency. The Expanded Prostate Cancer Index Composite (EPIC) is a validated instrument developed specifically for prostate cancer survivors. The EPIC-Sexual Inventory (EPIC-S) and EPIC-Urinary Inventory (EPIC-UIN) assess sexual and urinary function, respectively. We evaluated the usefulness of urinary and sexual function measured by EPIC at baseline and 3-month followup after prostatectomy to predict functional outcomes 1 year postoperatively. MATERIALS AND METHODS: We retrospectively reviewed a prospectively maintained, institutional review board approved database for patients treated with prostatectomy from 2000 to 2009. EPIC scores were acquired preoperatively, and at 3 and 12-month followups. We calculated the likelihood of sexual and urinary recovery at 12 months based on 3-month EPIC-UIN and EPIC-S scores. RESULTS: Patients were treated with open (226) or robotic (235) surgery. The 437 patients with complete EPIC-UIN questionnaires had worsened (2.7%), improved (47.8%) or stable (49.4%) urinary function, and the 436 with complete EPIC-S questionnaires had worsened (3.9%), improved (36.9%) or stable (59.2%) sexual function at 12 months compared to 3-month scores. Return to baseline was predicted by 3-month EPIC-UIN scores of 50 or greater (OR 7.76) and EPIC-S scores of 45 or greater (OR 3.64, each p <0.0001). The Pearson correlation coefficient of 3 and 12-month EPIC-UIN and EPIC-S scores was 0.65 and 0.73, respectively. CONCLUSIONS: Three-month EPIC-UIN and EPIC-S scores were useful for predicting 12-month functional outcomes. Health related quality of life instruments should be applied in the early postoperative period to aid in counseling patients on recovery.

A one-day couple group intervention to enhance sexual recovery for surgically treated men with prostate cancer and their partners: a pilot study.

Researchers evaluated the acceptance and effectiveness of a group intervention that provided education about post-prostatectomy sexual recovery and peer support for couples. Couples valued the intervention and retained the information. Partners became accepting of erectile dysfunction and communicated more openly about upsetting topics.

Understanding early functional recovery after robotic prostatectomy.

OBJECTIVES: The time to regain urinary control and sexual function after robotic-assisted prostatectomy varies widely. The authors performed a study to prospectively assess relationships between intraoperative processes and early functional recovery after surgery. METHODS: Prostate cancer patients undergoing robotic prostatectomy prospectively completed questionnaires (Expanded Prostate Cancer Index Composite-Short Form, Sexual Health Inventory for Men) preoperatively and at 3 months postoperatively. Relationships between intraoperative processes and early recovery were measured using multiple logistic regression. RESULTS: At 3 months, 73.9% and 29.7% of patients had recovered urinary and sexual function, respectively. Bladder neck preservation was associated with early recovery of both urinary and sexual function (P < .01). The quality of nerve sparing (P = .01), seminal vesicle sparing (P = .03), and the use of urethral suspension (P = .04) were associated with early recovery of sexual function. CONCLUSIONS: Early functional recovery for patients undergoing robotic-assisted prostatectomy varies by both patient characteristics and process measures. The causal link between intraoperative processes and patient outcomes merits further study through quality improvement collaboratives.

A comparison of extraperitoneal and intraperitoneal approaches for robotic prostatectomy.

OBJECTIVES: This study compared oncologic and health-related quality-of-life outcomes among patients undergoing intraperitoneal or extraperitoneal robotic prostatectomy. METHODS: Of 215 patients undergoing robotic prostatectomy, the approach was intraperitoneal in 48 and extraperitoneal in 167. Cancer control was evaluated using margin status. Recovery after surgery and functional health was assessed using the convalescence and recovery evaluation and expanded prostate cancer index composite questionnaires, respectively. RESULTS: Positive surgical margin rates were similar between approaches (14% extraperitoneal, 10% intraperitoneal; P = .63). Functional outcomes were slightly improved for those with the extraperitoneal approach (i.e., higher urinary irritation/obstruction scores at 3 months). The extraperitoneal group demonstrated higher activity (91.8 vs 83.3, P = .03) and cognitive scores (94.9 vs. 91.7, P = .04) at 6 weeks as well as higher gastrointestinal scores at 2 weeks (94.2 vs. 90.8, P = .05). CONCLUSIONS: These data support efforts to broaden the adoption of the extraperitoneal approach for robotic prostatectomy.

Genomic characterization of asymptomatic Escherichia coli isolated from the neobladder.

The replacement of the bladder with a neobladder made from ileal tissue is the prescribed treatment in some cases of bladder cancer or trauma. Studies have demonstrated that individuals with an ileal neobladder have recurrent colonization by Escherichia coli and other species that are commonly associated with urinary tract infections; however, pyelonephritis and complicated symptomatic infections with ileal neobladders are relatively rare. This study examines the genomic content of two E. coli isolates from individuals with neobladders using comparative genomic hybridization (CGH) with a pan-E. coli/Shigella microarray. Comparisons of the neobladder genome hybridization patterns with reference genomes demonstrate that the neobladder isolates are more similar to the commensal, laboratory-adapted E. coli and a subset of enteroaggregative E. coli than they are to uropathogenic E. coli isolates. Genes identified by CGH as exclusively present in the neobladder isolates among the 30 examined isolates were primarily from large enteric isolate plasmids. Isolations identified a large plasmid in each isolate, and sequencing confirmed similarity to previously identified plasmids of enteric species. Screening, via PCR, of more than 100 isolates of E. coli from environmental, diarrhoeagenic and urinary tract sources did not identify neobladder-specific genes that were widely distributed in these populations. These results taken together demonstrate that the neobladder isolates, while distinct, are genomically more similar to gastrointestinal or commensal E. coli, suggesting why they can colonize the transplanted intestinal tissue but rarely progress to acute pyelonephritis or more severe disease.

Patient preoperative expectations of urinary, bowel, hormonal and sexual functioning do not match actual outcomes 1 year after radical prostatectomy.

PURPOSE: We studied patient expectations of post-prostatectomy recovery from urinary incontinence, and urinary irritable, hormonal, bowel and sexual function symptoms after preoperative counseling. MATERIALS AND METHODS: Patients undergoing radical prostatectomy, recruited between June 2007 and November 2008, were extensively counseled preoperatively regarding expected outcomes. They were assessed at baseline and 1 year after surgery using the short form of the Expanded Prostate Index Composite. Their baseline expectations of functional outcomes 1 year after surgery were assessed using the Expanded Prostate Index Composite-Expectations. Pearson's correlation coefficient and a multiple linear regression were used to assess the associations between Expanded Prostate Index Composite-Expectations and Expanded Prostate Index Composite-Short Form at baseline and 1 year. RESULTS: A total of 152 consenting patients completed all questionnaires. Baseline sexual function score predicted significantly expectations of sexual function (p<0.0001) and urinary incontinence (p<0.0001) scores. Expanded Prostate Index Composite-Expectations predicted Expanded Prostate Index Composite-sexual function at 1 year (p<0.0001). Of the patients 36% and 40% expected the same as baseline function at 1 year in urinary incontinence and sexual function, respectively, and 17%, 45%, 39%, 15% and 32% expected worse than baseline function at 1 year in urinary incontinence, urinary irritable symptoms, bowel function, hormonal function and sexual function, respectively. One year after prostatectomy fewer than 22% of patients attained lower than expected urinary irritable symptoms, and bowel and hormonal function. However, 47% and 44% of patients attained lower than expected function for urinary incontinence and sexual function, respectively. Surprisingly 12% and 17% of patients expected better than baseline urinary incontinence and sexual function at 1 year after surgery. CONCLUSIONS: Men have unrealistic expectations of urinary and sexual function after prostatectomy despite preoperative counseling. We hypothesize potentially responsible psychological mechanisms. These data provide a baseline for further preoperative educational interventions.

Predicting 15-year prostate cancer specific mortality after radical prostatectomy.

PURPOSE: Long-term prostate cancer specific mortality after radical prostatectomy is poorly defined in the era of widespread screening. An understanding of the treated natural history of screen detected cancers and the pathological risk factors for prostate cancer specific mortality are needed for treatment decision making. MATERIALS AND METHODS: Using Fine and Gray competing risk regression analysis we modeled clinical and pathological data, and followup information on 11,521 patients treated with radical prostatectomy at a total of 4 academic centers from 1987 to 2005 to predict prostate cancer specific mortality. The model was validated on 12,389 patients treated at a separate institution during the same period. Median followup in the modeling and validation cohorts was 56 and 96 months, respectively. RESULTS: The overall 15-year prostate cancer specific mortality rate was 7%. Primary and secondary Gleason grade 4-5 (each p<0.001), seminal vesicle invasion (p<0.001) and surgery year (p=0.002) were significant predictors of prostate cancer specific mortality. A nomogram predicting 15-year prostate cancer specific mortality based on standard pathological parameters was accurate and discriminating with an externally validated concordance index of 0.92. When stratified by patient age at diagnosis, the 15-year prostate cancer specific mortality rate for pathological Gleason score 6 or less, 3+4, 4+3 and 8-10 was 0.2% to 1.2%, 4.2% to 6.5%, 6.6% to 11% and 26% to 37%, respectively. The 15-year prostate cancer specific mortality risk was 0.8% to 1.5%, 2.9% to 10%, 15% to 27% and 22% to 30% for organ confined cancer, extraprostatic extension, seminal vesicle invasion and lymph node metastasis, respectively. Only 3 of 9,557 patients with organ confined, pathological Gleason score 6 or less cancer died of prostate cancer. CONCLUSIONS: Poorly differentiated cancer and seminal vesicle invasion are the prime determinants of prostate cancer specific mortality after radical prostatectomy. The prostate cancer specific mortality risk can be predicted with remarkable accuracy after the pathological features of prostate cancer are known.

Identifying better practices for early-stage bladder cancer.

BACKGROUND: Practice guidelines for nonmuscle invasive (ie, early stage) bladder cancer are ambiguous, resulting in substantial practice variation without a clear patient benefit. OBJECTIVES: To profile urologist practice styles and empirically derive better patterns of use for common bladder cancer services. RESEARCH DESIGN: Retrospective cohort. SUBJECTS: Elderly patients diagnosed with early-stage bladder cancer between January 1, 1992 and December 31, 2005 in Surveillance, Epidemiology, and End Results-Medicare linked data. MEASURES: After identifying each patient's treating urologist, we fit multilevel models to obtain reliability-adjusted measures of the urologist's use of surveillance-associated (cytoscopy and urine cytology) and treatment-associated (intravesical therapy) services during the 2 years after diagnosis. We then used the Cox proportional hazards regression to evaluate the association between a patient's risk of bladder cancer death and his urologist's frequency of service use. RESULTS: Regardless of disease severity, no measurable patient benefit was associated with care delivery by a urologist residing in the highest quartile for cystoscopy or intravescial therapy use. However, maximal intensity of cytology use was associated with a lower risk of bladder cancer death for patients with high-grade stage Ta/Tis (highest vs. lowest intensity quartiles: hazard ratio, 0.73; 95% confidence interval, 0.56-0.95) and stage T1 disease (hazard ratio, 0.59; 95% confidence interval, 0.49-0.72). CONCLUSIONS: Our analysis supports a more tailored approach to patients with early-stage bladder cancer. Further, it serves as an example for applying observational data to characterize better clinical practices in the absence of experimental studies.

Five year expanded prostate cancer index composite-based quality of life outcomes after prostatectomy for localized prostate cancer.

OBJECTIVE: To document the Expanded Prostate cancer Index Composite (EPIC) results for men followed for 5 years after radical prostatectomy. PATIENTS AND METHODS: EPIC and demographic information were prospectively obtained from 434 patients who received questionnaires preoperatively and 1, 4, 12, 24, 36, 48 and 60 months postoperatively. Paired t-tests compared scores at individual time points. Percentage return to baseline was calculated at all postoperative time points and multivariate analyses evaluated postoperative trends. RESULTS: The mean age of patients was 63.4 years. Mean urinary function and incontinence worsen after prostatectomy, with recovery stable 12 months after surgery. Mean urinary bother returned to baseline by 4 months post-prostatectomy. Some 55.8% and 77.5% of patients return to their urinary function and bother baselines, respectively, 1 year after surgery. Mean sexual function and bother both declined after surgery, with new stable baselines achieved by 24 and 36 months post-prostatectomy, respectively. Of the patients, 24.2% returned to their sexual function baseline by 24 months. No postoperative improvement was noted in mean sexual bother until the 12 months post-prostatectomy. Of the patients, 36.8% returned to their sexual bother baseline by 36 months. Minimal change was noted in the bowel and hormonal domains. CONCLUSIONS: Mean urinary function and incontinence did not recover to preoperative baseline after prostatectomy, although it did not add distress because mean urinary bother returned to pre-prostatectomy levels. Mean sexual function declined post-prostatectomy, with continued recovery up to 24 months. Sexual bother recovered later but, once it reached a new baseline, the distress does not lessen with time, probably indicating an inability to adjust to their functional loss.

Do mixed histological features affect survival benefit from neoadjuvant platinum-based combination chemotherapy in patients with locally advanced bladder cancer? A secondary analysis of Southwest Oncology Group-Directed Intergroup Study (S8710).

OBJECTIVE: • To determine whether the effect of neoadjuvant chemotherapy with methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) on the survival of patients with locally advanced urothelial carcinoma (UC) of the bladder treated with radical cystectomy varies with the presence of non-urothelial components in the tumour. PATIENTS AND METHODS: • This is a secondary analysis of the Southwest Oncology Group-directed intergroup randomized trial S8710 of neoadjuvant MVAC followed by cystectomy versus cystectomy alone for treatment of locally advanced UC of the bladder. • For the purpose of these analyses, tumours were classified based on the presence of non-urothelial components as either pure UC (n= 236) or mixed tumours (n= 59). Non-urothelial components included squamous and glandular differentiation. • Cox regression models were used to estimate the effect of neoadjuvant MVAC on all-cause mortality for patients with pure UC and for patients with mixed tumours, with adjustment for age and clinical stage. RESULTS: • There was evidence of a survival benefit from chemotherapy in patients with mixed tumours (hazard ratio 0.46; 95% CI 0.25-0.87; P= 0.02). Patients with pure UC had improved survival on the chemotherapy arm but the survival benefit was not statistically significant (hazard ratio 0.90; 95% CI 0.67-1.21; P= 0.48). • There was marginal evidence that the survival benefit of chemotherapy in patients with mixed tumours was greater than it was for patients with pure UC (interaction P= 0.09). CONCLUSION: • Presence of squamous or glandular differentiation in locally advanced UC of the bladder does not confer resistance to MVAC and in fact may be an indication for the use of neoadjuvant chemotherapy before radical cystectomy.

The role of percutaneous renal biopsy in the management of small renal masses.

The use of percutaneous renal mass biopsy (RMB) has increased in recent years, likely in parallel with the growing incidence of renal cell carcinoma and small renal masses in particular. Biopsy and imaging techniques are improving, and diagnostic sufficiency and accuracy of RMB now are much higher in large-volume, experienced centers. Overall morbidity is low. This has led to a significant expansion of the indications for biopsy beyond documenting renal involvement for patients with metastatic disease or other systemic illnesses. While there still are limitations to its use and clinical judgment is paramount, RMB is proving to be a valuable tool in the clinical diagnosis and management of small renal masses.

Prediction of erectile function following treatment for prostate cancer.

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.

Development and validation of the Bladder Cancer Index: a comprehensive, disease specific measure of health related quality of life in patients with localized bladder cancer.

PURPOSE: We developed and validated a reliable, responsive multidimensional instrument to measure disease specific health related quality of life in bladder cancer survivors treated with local cancer therapy. MATERIALS AND METHODS: Instrument content was based on qualitative information obtained from a panel of bladder cancer providers and from patient focus groups. Draft items were piloted and revised, resulting in the 36-item Bladder Cancer Index consisting of urinary, bowel and sexual health domains. Internal consistency, test-retest reliability, convergent validity, concurrent validity and criterion validity were then assessed. RESULTS: Internal consistency was high at 0.77 to 0.91. Test-retest reliability was also high at 0.73 to 0.95. Correlations among the 3 domains were low (r < or = 0.39), indicating interscale independence. Health outcome discrimination was apparent in clinically distinct treatment groups. Moderate correlation was observed with existing external measures, indicating that the Bladder Cancer Index detects aspects of health related quality of life related to bladder cancer treatments that are not recorded by more general measures. CONCLUSIONS: The Bladder Cancer Index is a robust, multidimensional measure of bladder cancer specific health related quality of life and to our knowledge is the first available validated instrument to assess health outcomes across a range of local treatments commonly used for bladder cancer.

Accuracy of the extent of bladder cancer nodal metastases found at pelvic lymphadenectomy at the time of cystectomy: relation to primary tumor stage.

OBJECTIVES: To determine the minimum number of nodes (n(min)) that need to be removed to ascertain N(0) status with 90/95% certainty, and to determine the maximum number of nodes theoretically involved for a given number 'm' of involved nodes reported out of a total of 'n' nodes examined. METHODS: 2,025 patients underwent cystectomy and pelvic lymphadenectomy, with pathologic stage < or =pT(2) in 1,132 (55.9%) and > or =pT(3) in 893 (44.1%). A mathematical model was utilized, using incidences derived from those having > or =10 nodes retrieved. RESULTS: For stage < or =pT(2) and 0, 1, or 2 positive nodes reported, n(min) are 2, 27, and 28, respectively, for 90% accuracy and 12, 29, and 29, respectively, for 95% accuracy. For stage > or =pT(3) and 0, 1, or 2 positive nodes reported, n(min) are 19, 28, and 29, respectively, for 90% accuracy and 24, 29, and 30, respectively, for 95% accuracy. CONCLUSIONS: Accuracy of the extent of nodal involvement depends on the number of positive nodes reported, total number of nodes retrieved, and pathologic stage. This model allows clinicians to assess potential underestimation of the 'true' number of involved nodes for a given number of positive nodes out of a total number reported.