The Clinical Cell-Cycle Risk (CCR) Score Is Associated With Metastasis After Radiation Therapy and Provides Guidance on When to Forgo Combined Androgen Deprivation Therapy With Dose-Escalated Radiation.

PURPOSE: The clinical cell-cycle risk (CCR) score, which combines the University of California, San Francisco's Cancer of the Prostate Risk Assessment (CAPRA) and the cell cycle progression (CCP) molecular score, has been validated to be prognostic of disease progression for men with prostate cancer. This study evaluated the ability of the CCR score to prognosticate the risk of metastasis in men receiving dose-escalated radiation therapy (RT) with or without androgen deprivation therapy (ADT). METHODS AND MATERIALS: This retrospective, multi-institutional cohort study included men with localized National Comprehensive Cancer Network (NCCN) intermediate-, high-, and very high-risk prostate cancer (N = 741). Patients were treated with dose-escalated RT with or without ADT. The primary outcome was time to metastasis. RESULTS: The CCR score prognosticated metastasis with a hazard ratio (HR) per unit score of 2.22 (95% confidence interval [CI], 1.71-2.89; P < .001). The CCR score better prognosticated metastasis than NCCN risk group (CCR, P < .001; NCCN, P = .46), CAPRA score (CCR, P = .002; CAPRA, P = .59), or CCP score (CCR, P < .001; CCP, P = .59) alone. In bivariable analyses, CCR score remained highly prognostic when accounting for ADT versus no ADT (HR, 2.18; 95% CI, 1.61-2.96; P < .001), ADT duration as a continuous variable (HR, 2.11; 95% CI, 1.59-2.79; P < .001), or ADT given at or below the recommended duration for each NCCN risk group (HR, 2.19; 95% CI, 1.69-2.86; P < .001). Men with CCR scores below or above the multimodality threshold (CCR score, 2.112) had a 10-year risk of metastasis of 3.7% and 21.24%, respectively. Men with below-threshold scores receiving RT alone had a 10-year risk of metastasis of 3.7%, and for men receiving RT plus ADT, the 10-year risk of metastasis was also 3.7%. CONCLUSIONS: The CCR score accurately and precisely prognosticates metastasis and adds clinically actionable information relative to guideline-recommended therapies based on NCCN risk in men undergoing dose-escalated RT with or without ADT. For men with scores below the multimodality threshold, adding ADT may not significantly reduce their 10-year risk of metastasis.

A Retrospective Observational Analysis of Overall Survival with Sipuleucel-T in Medicare Beneficiaries Treated for Advanced Prostate Cancer.

INTRODUCTION: Since sipuleucel-T approval in 2010, the treatment landscape for metastatic castration-resistant prostate cancer (mCRPC) now includes the androgen-receptor signaling pathway inhibitors (ASPIs) abiraterone acetate or enzalutamide. In 2013 and 2014, these oral agents were approved for use in men with metastatic prostate cancer who had minimal to no symptoms. We compared overall survival (OS) in men who received their first mCRPC treatment using the Medicare Fee-for-Service 100% administrative claims research dataset with patient-level linkage to the National Death Index. METHODS: This retrospective cohort analysis (January 2013 to December 2017) included men who were chemo-naïve at treatment start in 2014 and who had continuous Medicare Parts A, B, and D eligibility during the 3-year observation period. We compared: first-line sipuleucel-T vs. first-line ASPIs and any-line sipuleucel-T vs. any-line ASPIs (without sipuleucel-T). We used a multivariable regression model to help control for potentially confounding factors while assessing survival outcomes. RESULTS: The model included 6044 eligible men (average age 75-78 years) with similar disease severity; > 80% were white. Median OS, presented as sipuleucel-T vs. ASPI, was 35.2 vs. 20.7 months (n, 906 vs. 5092; any-line cohort) and 34.9 vs. 21.0 months (n, 647 vs. 4810; first-line cohort). Model outcomes indicated sipuleucel-T was associated with significantly prolonged OS compared with ASPIs: adjusted hazard ratio, 0.59 (95% CI 0.527-0.651) and 0.56 (0.494-0.627) for the any-line and first-line cohorts, respectively. CONCLUSION: This analysis suggests use of sipuleucel-T at any time was associated with improved OS compared with ASPI use alone. Of note, these analyses are intended as descriptive rather than definitive as this dataset contains limited data on key clinical factors. While selection bias is a risk in secondary claims data, this research provides important insight into real-world treatment outcomes.

17-Gene Genomic Prostate Score Test Results in the Canary Prostate Active Surveillance Study (PASS) Cohort.

PURPOSE: The 17-gene Oncotype DX Genomic Prostate Score (GPS) test predicts adverse pathology (AP) in patients with low-risk prostate cancer treated with immediate surgery. We evaluated the GPS test as a predictor of outcomes in a multicenter active surveillance cohort. MATERIALS AND METHODS: Diagnostic biopsy tissue was obtained from men enrolled at 8 sites in the Canary Prostate Active Surveillance Study. The primary endpoint was AP (Gleason Grade Group [GG] ≥ 3, ≥ pT3a) in men who underwent radical prostatectomy (RP) after initial surveillance. Multivariable regression models for interval-censored data were used to evaluate the association between AP and GPS. Inverse probability of censoring weighting was applied to adjust for informative censoring. Predictiveness curves were used to evaluate how models stratified risk of AP. Association between GPS and time to upgrade on surveillance biopsy was evaluated using Cox proportional hazards models. RESULTS: GPS results were obtained for 432 men (median follow-up, 4.6 years); 101 underwent RP after a median 2.1 years of surveillance, and 52 had AP. A total of 167 men (39%) upgraded at a subsequent biopsy. GPS was significantly associated with AP when adjusted for diagnostic GG (hazards ratio [HR]/5 GPS units, 1.18; 95% CI, 1.04 to 1.44; P = .030), but not when also adjusted for prostate-specific antigen density (PSAD; HR, 1.85; 95% CI, 0.99 to 4.19; P = .066). Models containing PSAD and GG, or PSAD, GG, and GPS may stratify risk better than a model with GPS and GG. No association was observed between GPS and subsequent biopsy upgrade (P = .48). CONCLUSION: In our study, the independent association of GPS with AP after initial active surveillance was not statistically significant, and there was no association with upgrading in surveillance biopsy. Adding GPS to a model containing PSAD and diagnostic GG did not significantly improve stratification of risk for AP over the clinical variables alone.

Performance of PCA3 and TMPRSS2:ERG urinary biomarkers in prediction of biopsy outcome in the Canary Prostate Active Surveillance Study (PASS).

BACKGROUND: For men on active surveillance for prostate cancer, biomarkers may improve prediction of reclassification to higher grade or volume cancer. This study examined the association of urinary PCA3 and TMPRSS2:ERG (T2:ERG) with biopsy-based reclassification. METHODS: Urine was collected at baseline, 6, 12, and 24 months in the multi-institutional Canary Prostate Active Surveillance Study (PASS), and PCA3 and T2:ERG levels were quantitated. Reclassification was an increase in Gleason score or ratio of biopsy cores with cancer to ≥34%. The association of biomarker scores, adjusted for common clinical variables, with short- and long-term reclassification was evaluated. Discriminatory capacity of models with clinical variables alone or with biomarkers was assessed using receiver operating characteristic (ROC) curves and decision curve analysis (DCA). RESULTS: Seven hundred and eighty-two men contributed 2069 urine specimens. After adjusting for PSA, prostate size, and ratio of biopsy cores with cancer, PCA3 but not T2:ERG was associated with short-term reclassification at the first surveillance biopsy (OR = 1.3; 95% CI 1.0-1.7, p = 0.02). The addition of PCA3 to a model with clinical variables improved area under the curve from 0.743 to 0.753 and increased net benefit minimally. After adjusting for clinical variables, neither marker nor marker kinetics was associated with time to reclassification in subsequent biopsies. CONCLUSIONS: PCA3 but not T2:ERG was associated with cancer reclassification in the first surveillance biopsy but has negligible improvement over clinical variables alone in ROC or DCA analyses. Neither marker was associated with reclassification in subsequent biopsies.

Continued 5α-Reductase Inhibitor Use after Prostate Cancer Diagnosis and the Risk of Reclassification and Adverse Pathological Outcomes in the PASS.

PURPOSE: Outcomes in patients who enroll in active surveillance programs for prostate cancer while receiving 5α-reductase inhibitors have not been well defined. We sought to determine the association of 5α-reductase inhibitor use with the risk of reclassification in the PASS (Canary Prostate Active Surveillance Study). MATERIALS AND METHODS: Participants in the multicenter PASS were enrolled between 2008 and 2016. Study inclusion criteria were current or never 5α-reductase inhibitors use, Gleason score 3 + 4 or less prostate cancer at diagnosis, less than a 34% core involvement ratio at diagnosis and 1 or more surveillance biopsies. Included in study were 1,009 men, including 107 on 5α-reductase inhibitors and 902 who had never received 5α-reductase inhibitors. Reclassification was defined as increase in the Gleason score and/or an increase to 34% or greater in the ratio of biopsy cores positive for cancer. Adverse pathology at prostatectomy was defined as Gleason 4 + 3 or greater and/or nonorgan confined disease (pT3 or N1). RESULTS: On multivariable analysis there was no difference in reclassification between men who had received and those who had never received 5α-reductase inhibitors (HR 0.81, p = 0.31). Patients who had received 5α-reductase inhibitors were less likely to undergo radical prostatectomy (8% vs 18%, p = 0.01) or any definitive treatment (19% vs 24%, p = 0.04). In the 167 participants who underwent radical prostatectomy there was no suggestion of a difference in the rate of adverse pathology findings at prostatectomy between 5α-reductase inhibitor users and nonusers. CONCLUSIONS: Continued 5α-reductase inhibitor use after an initial diagnosis of prostate cancer was not associated with the risk of reclassification on active surveillance in men in the PASS cohort.

Refined Analysis of Prostate-specific Antigen Kinetics to Predict Prostate Cancer Active Surveillance Outcomes.

BACKGROUND: For men on active surveillance for prostate cancer, utility of prostate-specific antigen (PSA) kinetics (PSAk) in predicting pathologic reclassification remains controversial. OBJECTIVE: To develop prediction methods for utilizing serial PSA and evaluate frequency of collection. DESIGN, SETTING, AND PARTICIPANTS: Data were collected from men enrolled in the multicenter Canary Prostate Active Surveillance Study, for whom PSA data were measured and biopsies performed on prespecified schedules. We developed a PSAk parameter based on a linear mixed-effect model (LMEM) that accounted for serial PSA levels. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The association of diagnostic PSA and/or PSAk with time to reclassification (increase in cancer grade and/or volume) was evaluated using multivariable Cox proportional hazards models. RESULTS AND LIMITATIONS: A total of 851 men met the study criteria; 255 (30%) had a reclassification event within 5 yr. Median follow-up was 3.7 yr. After adjusting for prostate size, time since diagnosis, biopsy parameters, and diagnostic PSA, PSAk was a significant predictor of reclassification (hazard ratio for each 0.10 increase in PSAk=1.6 [95% confidence interval 1.2-2.1, p<0.001]). The PSAk model improved stratification of risk prediction for the top and bottom deciles of risk over a model without PSAk. Model performance was essentially identical using PSA data measured every 6 mo to those measured every 3 mo. The major limitation is the reliability of reclassification as an end point, although it drives most treatment decisions. CONCLUSIONS: PSAk calculated using an LMEM statistically significantly predicts biopsy reclassification. Models that use repeat PSA measurements outperform a model incorporating only diagnostic PSA. Model performance is similar using PSA assessed every 3 or 6 mo. If validated, these results should inform optimal incorporation of PSA trends into active surveillance protocols and risk calculators. PATIENT SUMMARY: In this report, we looked at whether repeat prostate-specific antigen (PSA) measurements, or PSA kinetics, improve prediction of biopsy outcomes in men using active surveillance to manage localized prostate cancer. We found that in a large multicenter active surveillance cohort, PSA kinetics improves the prediction of surveillance biopsy outcome.

Role of Surveillance Biopsy with No Cancer as a Prognostic Marker for Reclassification: Results from the Canary Prostate Active Surveillance Study.

BACKGROUND: Many patients who are on active surveillance (AS) for prostate cancer will have surveillance prostate needle biopsies (PNBs) without any cancer evident. OBJECTIVE: To define the association between negative surveillance PNBs and risk of reclassification on AS. DESIGN, SETTING, AND PARTICIPANTS: All men were enrolled in the Canary Prostate Active Surveillance Study (PASS) between 2008 and 2016. Men were included if they had Gleason ≤3+4 prostate cancer and <34% core involvement ratio at diagnosis. Men were prescribed surveillance PNBs at 12 and 24 mo after diagnosis and then every 24 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Reclassification was defined as an increase in Gleason grade and/or an increase in the ratio of biopsy cores to cancer to ≥34%. PNB outcomes were defined as follows: (1) no cancer on biopsy, (2) cancer without reclassification, or (3) reclassification. Kaplan-Meier and Cox proportional hazard models were performed to assess the risk of reclassification. RESULTS AND LIMITATIONS: A total of 657 men met inclusion criteria. On first surveillance PNB, 214 (32%) had no cancer, 282 (43%) had cancer but no reclassification, and 161 (25%) reclassified. Among those who did not reclassify, 313 had a second PNB. On second PNB, 120 (38%) had no cancer, 139 (44%) had cancer but no reclassification, and 54 (17%) reclassified. In a multivariable analysis, significant predictors of decreased future reclassification after the first PNB were no cancer on PNB (hazard ratio [HR]=0.50, p=0.008), lower serum prostate-specific antigen, larger prostate size, and lower body mass index. A finding of no cancer on the second PNB was also associated with significantly decreased future reclassification in a multivariable analysis (HR=0.15, p=0.003), regardless of the first PNB result. The major limitation of this study is a relatively small number of patients with long-term follow-up. CONCLUSIONS: Men who have a surveillance PNB with no evidence of cancer are significantly less likely to reclassify on AS in the PASS cohort. These findings have implications for tailoring AS protocols. PATIENT SUMMARY: Men on active surveillance for prostate cancer who have a biopsy showing no cancer are at a decreased risk of having worse disease in the future. This may have an impact on how frequently biopsies are required to be performed in the future.

Evaluating the Four Kallikrein Panel of the 4Kscore for Prediction of High-grade Prostate Cancer in Men in the Canary Prostate Active Surveillance Study.

BACKGROUND: Diagnosis of Gleason 6 prostate cancer can leave uncertainty about the presence of undetected aggressive disease. OBJECTIVE: To evaluate the utility of a four kallikrein (4K) panel in predicting the presence of high-grade cancer in men on active surveillance. DESIGN, SETTING, AND PARTICIPANTS: Plasma collected before the first and subsequent surveillance biopsies was assessed for 718 men prospectively enrolled in the multi-institutional Canary PASS trial. Biopsy data were split 2:1 into training and test sets. We developed statistical models that included clinical information and either the 4Kpanel or serum prostate-specific antigen (PSA). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The endpoint was reclassification to Gleason ≥7. We used receiver operating characteristic (ROC) curve analyses and area under the curve (AUC) to assess discriminatory capacity, and decision curve analysis (DCA) to report clinical net benefit. RESULTS AND LIMITATIONS: Significant predictors for reclassification were 4Kpanel (odds ratio [OR] 1.54, 95% confidence interval [CI] 1.31-1.81) or PSA (OR 2.11, 95% CI 1.53-2.91), ≥20% cores positive (OR 2.10, 95% CI 1.33-3.32), two or more prior negative biopsies (OR 0.19, 95% CI 0.04-0.85), prostate volume (OR 0.47, 95% CI 0.31-0.70), and body mass index (OR 1.09, 95% CI 1.04-1.14). ROC curve analysis comparing 4K and base models indicated that the 4Kpanel improved accuracy for predicting reclassification (AUC 0.78 vs 0.74) at the first surveillance biopsy. Both models performed comparably for prediction of reclassification at subsequent biopsies (AUC 0.75 vs 0.76). In DCA, both models showed higher net benefit compared to biopsy-all and biopsy-none strategies. Limitations include the single cohort nature of the study and the small numbers; results should be validated in another cohort before clinical use. CONCLUSIONS: The 4Kpanel provided incremental value over routine clinical information in predicting high-grade cancer in the first biopsy after diagnosis. The 4Kpanel did not add predictive value to the base model at subsequent surveillance biopsies. PATIENT SUMMARY: Active surveillance is a management strategy for many low-grade prostate cancers. Repeat biopsies monitor for previously undetected high-grade cancer. We show that a model with clinical variables, including a panel of four kallikreins, indicates the presence of high-grade cancer before a biopsy is performed.

Percutaneous transhepatic holmium laser lithotripsy of a large common bile duct stone.

A 58-year-old woman presented with a 4 cm obstructing choledocolith within the proximal common bile duct. She had an extensive operative history resulting in common bile duct to jejunum anastomosis after cholecystectomy. Endoscopic retrograde cholangiopancreatography (ERCP) removal was unsuccessful, and surgical exploration was contraindicated due to multiple comorbidities. Interventional radiologist placement of bilateral transhepatic ureteral access sheaths allowed Urologist evaluation of the biliary tract by ureteroscope. Holmium laser lithotripsy was performed with successful fragmentation of the stone and clearance of the obstruction, without complication. The case is relevant to the growing literature on the management of refractory biliary stones after failed ERCP.

Recipient graft failure or death impact on living kidney donor quality of life based on the living organ donor network database.

BACKGROUND AND PURPOSE: There is a paucity of prospective long-term data on living kidney donor (LKD) quality of life (QoL). The Living Organ Donor Network (LODN) database follows donors longitudinally and cross-references with United Network for Organ Sharing (UNOS) data to assess factors that affect donor QoL. PATIENTS AND METHODS: The Short Form (SF)-36 was sent to donors at 6 months and yearly thereafter. Recipient outcomes were determined from the UNOS database. Of 2219 donors, 1030 returned ≥ 1 QoL survey in the first year. Seven-hundred and thirty-one donors returned at least two surveys with 51 associated with a nonfunctioning graft and 38 with recipient death. RESULTS: Initial QoL scores were not different between donors whose recipients were alive with graft function, and those whose recipients died (88.9 vs 89.2, P = 0.87). For donors whose recipient died, QoL in the year after recipient death averaged 6 points lower than the initial QoL (88.9 vs 82.9, P = 0.01). Thirty-one donors returned surveys an average of 4.1 years after their recipient's death. Final QoL score increased by 2.5 points, no longer significantly lower than the initial QoL (85.4 vs 88.9, P = 0.16). Thirty-eight donors returned surveys in the year after their recipient's graft failure and their QoL decreased by 5.6 points on average (86.9 vs 81.2, P = 0.07). Twenty-eight of these donors returned future surveys and final QoL was unchanged (81.2 vs 81.2, P = 0.99). CONCLUSIONS: Donor QoL declines after recipient death but recovers with time. Graft failure resulted in decreased QoL without recovery. The LODN database identifies factors affecting LKD QoL and provides a model for a national registry.

Positive surgical margins after robotic assisted radical prostatectomy: a multi-institutional study.

PURPOSE: Positive surgical margins are an independent predictive factor for biochemical recurrence after radical prostatectomy. We analyzed the incidence of and associative factors for positive surgical margins in a multi-institutional series of 8,418 robotic assisted radical prostatectomies. MATERIALS AND METHODS: We analyzed the records of 8,418 patients who underwent robotic assisted radical prostatectomy at 7 institutions. Of the patients 323 had missing data on margin status. Positive surgical margins were categorized into 4 groups, including apex, bladder neck, posterolateral and multifocal. The records of 6,169 patients were available for multivariate analysis. The variables entered into the logistic regression models were age, body mass index, preoperative prostate specific antigen, biopsy Gleason score, prostate weight and pathological stage. A second model was built to identify predictive factors for positive surgical margins in the subset of patients with organ confined disease (pT2). RESULTS: The overall positive surgical margin rate was 15.7% (1,272 of 8,095 patients). The positive surgical margin rate for pT2 and pT3 disease was 9.45% and 37.2%, respectively. On multivariate analysis pathological stage (pT2 vs pT3 OR 4.588, p<0.001) and preoperative prostate specific antigen (4 or less vs greater than 10 ng/ml OR 2.918, p<0.001) were the most important independent predictive factors for positive surgical margins after robotic assisted radical prostatectomy. Increasing prostate weight was associated with a lower risk of positive surgical margins after robotic assisted radical prostatectomy (OR 0.984, p<0.001) and a higher body mass index was associated with a higher risk of positive surgical margins (OR 1.032, p<0.001). For organ confined disease preoperative prostate specific antigen was the most important factor that independently correlated with positive surgical margins (4 or less vs greater than 10 ng/ml OR 3.8, p<0.001). CONCLUSIONS: The prostatic apex followed by a posterolateral site was the most common location of positive surgical margins after robotic assisted radical prostatectomy. Factors that correlated with cancer aggressiveness, such as pathological stage and preoperative prostate specific antigen, were the most important factors independently associated with an increased risk of positive surgical margins after robotic assisted radical prostatectomy.

Second prize: Recurrence rates after percutaneous and laparoscopic renal cryoablation of small renal masses: does the approach make a difference?

BACKGROUND AND PURPOSE: As radiologic detection of small renal masses increases, patients are increasingly offered percutaneous renal cryoablation (PRC) or transperitoneal laparoscopic renal cryoablation (TLRC). This multicenter experience compares these approaches. PATIENTS AND METHODS: Between September 1998 and May 2010, review of our PRC and TLRC experience was performed. Patients with ≥ 12-month follow-up were included for analysis. Post-treatment surveillance consisted of laboratory studies and imaging at regular intervals. Treatment failure was considered if persistent mass enhancement or interval tumor growth was radiographically evident. Repeated biopsy and re-treatment were recommended in the event of recurrence. RESULTS: Sixty-one patients underwent PRC and 84 patients underwent TLRC. No significant differences were noted with respect to demographic factors. Mean tumor size was 2.7 ± 1.1 cm (PRC) and 2.5 ± 0.8 (TLRC) cm (P = 0.090). Mean follow-up was 31.0 ± 15.9 months (PRC) and 42.3 ± 21.2 (TLRC) months (P = 0.008), with local tumor recurrence noted in 10/61 (16.4%) PRC and 5/84 (5.9%) TLRC (P = 0.042). For PRC, disease-free survival (DFS) and overall survival (OS) were 93.7% and 88.9%, respectively, with four patients having evidence of disease at last follow-up. DFS and OS were 91.7% and 89.3% for TLRC, with seven patients having evidence of disease at last follow-up. DFS (P = 0.654) and OS (P = 0.939) were similar. CONCLUSIONS: In this multicenter study of well-matched cohorts, PRC had higher primary treatment failure rates than TLRC. While no differences were noted between DFS and OS, analysis is limited by intermediate follow-up. Further study is necessary to discern reasons for the higher recurrence rates in PRC and to determine what long-term consequences exist.

Posterior reconstruction before vesicourethral anastomosis in patients undergoing robot-assisted laparoscopic prostatectomy leads to earlier return to baseline continence.

INTRODUCTION: Reapproximation of Denonvilliers' fascia adjacent to bladder neck to the rectourethralis, or posterior reconstruction (PR), has been suggested to improve continence in postprostatectomy patients. We examined the impact of the PR on postoperative urinary and other quality-of-life (QoL) outcomes in patients undergoing robot-assisted laparoscopic prostatectomy (RALP). METHODS: We identified 89 patients who underwent RALP for prostate cancer between 2006 and 2009 by a single surgeon (R.G.), consented to participate in our prospective QoL study, which collects RAND-UCLA QoL and AUA symptom scores for all patients undergoing treatment for prostate cancer, and completed a baseline and a 3- or 6-month questionnaire. Of these, 31 patients had PR before vesicourethral anastomosis. We compared return to baseline function percentage at 3 and 6 months by PR group. Differences found in univariate analysis were further investigated using multiple linear regression models adjusting for demographics, clinical variables, and nerve-sparing status. RESULTS: While most patients had both 3- and 6-month follow-up (n = 74, 83%), sample size at 3 months was n = 86 and at 6 months was n = 77. Groups were comparable by preoperative characteristics, pathologic stage, nerve-sparing status, and baseline QoL/AUA symptom scores. At 3-months, there was a statistically significant improvement comparing PR to non-PR groups in return to baseline score for urinary bother (72% vs. 53%; p = 0.008) and urinary function (64% vs. 50%; p = 0.05), as well as change in absolute AUA symptom score (+0.2 vs. +3.8; p = 0.005). Differences in urinary bother (+20%; 95% confidence interval 5%, 34%) and AUA symptom score (-2.8; 95% confidence interval, -5.4, -0.2) persisted after multivariate adjustment. Groups had similar scores for all parameters by 6 months postprostatectomy. CONCLUSIONS: PR in patients undergoing RALP has a significant impact on early return to baseline parameters relating to urinary bother, urinary function, and AUA symptom score.

Quality of life after open or robotic prostatectomy, cryoablation or brachytherapy for localized prostate cancer.

PURPOSE: Health related quality of life concerns factor prominently in prostate cancer management. We describe health related quality of life impact and recovery profiles of 4 commonly used operative treatments for localized prostate cancer. MATERIALS AND METHODS: Beginning in February 2000 all patients treated with open radical prostatectomy, robot assisted laparoscopic prostatectomy, brachytherapy or cryotherapy were asked to complete the UCLA-PCI questionnaire before treatment, and at 3, 6, 12, 18, 24, 30 and 36 months after treatment. Outcomes were compared across treatment types with statistical analysis using univariate and multivariate models. RESULTS: A total of 785 patients treated between February 2000 and December 2008 were included in the analysis with a mean followup of 24 months. All health related quality of life domains were adversely affected by all treatments and recovery profiles varied significantly by treatment type. Overall urinary function and bother outcomes scored significantly higher after brachytherapy and cryotherapy compared to open radical prostatectomy and robotic assisted laparoscopic radical prostatectomy. Brachytherapy and cryotherapy had a 3-fold higher rate of return to baseline urinary function compared to open radical prostatectomy and robotic assisted laparoscopic radical prostatectomy. Sexual function and bother scores were highest after brachytherapy, with a 5-fold higher rate of return to baseline function compared to cryotherapy, open radical prostatectomy and robotic assisted laparoscopic radical prostatectomy. All 4 treatments were associated with relatively transient and less pronounced impact on bowel function and bother. CONCLUSIONS: In a study of sequential health related quality of life assessments brachytherapy and cryotherapy were associated with higher urinary function and bother scores compared to open radical prostatectomy and da Vinci prostatectomy. Brachytherapy was associated with higher sexual function and bother scores compared to open radical prostatectomy, robotic assisted laparoscopic radical prostatectomy and cryotherapy.

Renal functional outcomes after cryoablation of small renal masses.

BACKGROUND AND PURPOSE: Renal function outcomes after renal cryosurgery have not been widely scrutinized. We report 2-year renal function outcomes from a single-center cohort of patients who were treated with cryoablation for small renal masses. METHODS: We performed a retrospective review of our laparoscopic and percutaneous renal cryoablation experience between January 2003 and April 2007. Global renal function was assessed using measured serum creatinine and estimated glomerular filtration rate (eGFR) (MDRD equation). Chronic kidney disease (CKD) was defined as a serum creatinine level >2.0 mg/dL or eGFR <60 mL/min/1.73 m(2). RESULTS: Sixty-two patients were included in the analysis. Mean follow-up was 30 months (range 13-63 mos). Mean tumor size was 2.33 cm (range 1-4.6 cm). Comorbid conditions were prevalent: 77% hypertension, 35% hyperlipidemia, 31% diabetes mellitus, 39% tobacco use, and 32% heart disease (coronary artery disease/congestive heart failure). Based on eGFR calculations, preoperative CKD was noted in 17 of 62 (27%) patients. De novo CKD was noted in 5 of 45 (11%) patients. Patients in whom de novo CKD developed had lower pretreatment eGFR (71.0 vs 98.4 60 mL/min/1.73 m(2), P = 0.03) and larger tumor size (2.94 vs 2.19 cm, P = 0.04) compared with patients who were maintaining normal renal function. When CKD was defined as creatinine level >2.0 mg/dL, only one and six patients were identified with preoperative and de novo CKD, respectively. CONCLUSIONS: In a cohort of renal cryosurgery patients who were characterized by highly prevalent medical comorbidities, renal function was generally well maintained, with a low rate of de novo CKD based on eGFR calculations. A serum creatinine level >2.0 mg/dL was a less sensitive measure of CKD.

Single center experience with percutaneous and laparoscopic cryoablation of small renal masses.

BACKGROUND AND PURPOSE: While partial nephrectomy remains the gold standard for the management of most small renal masses, increasing experience with renal cryoablation has suggested a viable alternative with a favorable morbidity profile and good efficacy. We report intermediate-term oncologic outcomes from a single-center experience with laparoscopic and percutaneous renal cryoablation. PATIENTS AND METHODS: We performed a retrospective review of our laparoscopic renal cryoablation (LRC) and percutaneous renal cryoablation (PRC) experience between January 2003 and April 2007. Patients with at least 12 months of follow-up were included in the analysis. Follow-up consisted of imaging and laboratory studies at regular intervals. Persistent mass enhancement or interval tumor growth was considered a treatment failure. RESULTS: Sixty-six patients (44% women/56% men; 42% African-American/58% Caucasian/other; mean body mass index, 29.7) with 72 tumors underwent either LRC (n = 52) or PRC (n = 20) with a mean follow-up of 30 months (median 25.1 mos; range 13-63 mos). Average patient age was 66.5 years (range 34-82 yrs). Mean tumor size was 2.33 cm (range 1-4.6 cm). Comorbid conditions were prevalent: 76% hypertension, 36% hyperlipidemia, 24% chronic kidney disease, 29% diabetes mellitus, 36% tobacco use, and 32% heart disease. RESULTS of pretreatment biopsy were 62% renal-cell carcinoma and 38% benign or nondiagnostic. Overall cancer-specific and cancer-free survival were 100% and 97%, respectively. There were two treatment failures (3.8%) in the LRC group and five primary failures in the PRC group (25%) (P = 0.015), four of which were salvaged with repeated PRC with no evidence of recurrence at 6 to 36 months of follow-up. There has been no significant local or metastatic progression. CONCLUSIONS: LRC and PRC achieved good oncologic control with minimal morbidity at a mean follow-up of 30 months in a patient cohort characterized by numerous comorbid conditions. PRC had a significantly higher primary treatment failure rate than LRC, but re-treatment offered salvage oncologic control with no significant complications.

Is there correlation of nerve-sparing status and return to baseline urinary function after robot-assisted laparoscopic radical prostatectomy?

BACKGROUND AND PURPOSE: Incontinence is a vital quality-of-life (QoL) concern for men undergoing radical prostatectomy. Using validated QoL instruments, we sought to determine if urinary function was affected by nerve-sparing status at prostatectomy and how this correlated with the three modalities of prostate cancer surgery practiced at our institution: Retropubic radical prostatectomy (RRP), laparoscopic radical prostatectomy (LRP), or robot-assisted laparoscopic radical prostatectomy (RALRP). PATIENTS AND METHODS: Percent of baseline urinary function (PBUF) score was calculated by dividing follow-up urinary function score by baseline urinary function score. Patients with a function score of <30 at baseline (n = 10, 2%) were excluded from analyses. PBUF was compared across categories of nerve-sparing surgery at 3, 6, 12, 18, 24, 30, and 36 months. Survival analysis was conducted classifying a follow-up achievement of 75% percent of baseline score as a successful outcome. RESULTS: Overall, 628 patients were available for analysis. Age, clinical stage, Gleason score, modality of surgery, mean baseline sexual function, and ability to have intercourse significantly affected PBUF. The significance of nerve-sparing status across groups was demonstrated only at 3 months postoperatively. Univariate analysis demonstrated a significant trend of returning to 75% of baseline urinary function in the bilateral nerve-sparing group. Multivariate analysis showed no correlation between type of nerve sparing, type of surgery, and PBUF. CONCLUSION: Percent return of baseline urinary function is not significantly affected by nerve-sparing status after radical prostatectomy. RALRP demonstrates nonstatistically significant trends of patients returning to baseline urinary function when compared with other modalities.

Usefulness of adrenal vein sampling in the evaluation of aldosteronism.

PURPOSE: To determine the usefulness of adrenal vein sampling (AVS) in patients referred for surgical management of primary aldosteronism (PA). PATIENTS AND METHODS: From July 2001 to September 2006, 12 patients with a mean age of 49.3 years (range 31-65 yrs) presented for evaluation. All patients had PA based on serologic screening tests and were evaluated with CT abdominal imaging. Eleven (92%) patients underwent AVS with corticotropin stimulation. Ten patients underwent laparoscopic adrenalectomy for resection of an aldosterone-producing adenoma. RESULTS: All patients had an adrenal adenoma seen on CT, mean size 14.8 mm (range 6-27 mm). AVS was performed in the 11 patients. When compared with CT findings, eight (73%) patients demonstrated aldosterone hypersecretion from the adrenal with the adenoma. Two (18%) patients demonstrated hypersecretion from the contralateral, normal-appearing gland. One (9%) patient demonstrated bilateral aldosterone hypersecretion, consistent with bilateral adrenal hyperplasia. After surgical removal of the gland that demonstrated hypersecretion on AVS, all patients experienced resolution of hypokalemia, five (50%) patients had resolution of hypertension, and five (50%) patients had significant reductions in the number of hypertensive medications. CONCLUSIONS: AVS is a superior test when compared with CT imaging in subtype identification of PA and for determination of occult hypersecretion from the adrenal. Patients who are evaluated for potential adrenalectomy should routinely undergo AVS.

Prospective randomized trial comparing shock wave lithotripsy and ureteroscopy for lower pole caliceal calculi 1 cm or less.

PURPOSE: The optimal management of lower pole renal calculi is controversial. We compared shock wave lithotripsy (SWL) and ureteroscopy (URS) for the treatment of patients with small lower pole stones in a prospective, randomized, multicenter trial. MATERIALS AND METHODS: A total of 78 patients with 1 cm or less isolated lower pole stones were randomized to SWL or URS. The primary outcome measure was stone-free rate on noncontrast computerized tomography at 3 months. Secondary outcome parameters were length of stay, complication rates, need for secondary procedures and patient derived quality of life measures. RESULTS: A total of 67 patients randomized to SWL (32) or URS (35) completed treatment. The 2 groups were comparable with respect to age, sex, body mass index, side treated and stone surface area. Operative time was significantly shorter for SWL than URS (66 vs 90 minutes). At 3 months of followup 26 and 32 patients who underwent SWL and URS had radiographic followup that demonstrated a stone-free rate of 35% and 50%, respectively (p not significant). Intraoperative complications occurred in 1 SWL case (unable to target stone) and in 7 URS cases (failed access in 5 and perforation in 2), while postoperative complications occurred in 7 SWL and 7 URS cases. Patient derived quality of life measures favored SWL. CONCLUSIONS: This study failed to demonstrate a statistically significant difference in stone-free rates between SWL and URS for the treatment of small lower pole renal calculi. However, SWL was associated with greater patient acceptance and shorter convalescence.

Robot-assisted vaginal construction using ileum in a case of Mayer-Rokitansky-Küster-Hauser syndrome.

Congenital absence of the vagina is a rare condition commonly associated with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome, Morris Syndrome, and XY sex reversal. Secondarily this condition may be caused by exenteration of various pelvic tumors. Surgical options for treating this devastating condition include external vaginal dilation, internal dilation using traction devices, and vaginal construction using flaps of skin, bladder, or various bowel segments. We describe our innovative surgical technique employing robotic assistance in the creation of a neo-vagina for a young woman with MRKH syndrome. To the best of our knowledge this is the first report of this surgical technique.