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.

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.

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.

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.

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.

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.

Postoperative robotic telerounding: a multicenter randomized assessment of patient outcomes and satisfaction.

HYPOTHESIS: Patient safety and satisfaction are adversely affected when robotic videoconferencing (telerounding) is used in the postoperative setting. DESIGN: Randomized controlled trial. SETTING: Three academic institutions. PATIENTS: A total of 270 adults undergoing a urologic procedure requiring a hospital stay of 24 to 72 hours were randomized to receive either traditional bedside rounds or robotic telerounds. MAIN OUTCOME MEASURES: The primary outcome measure was postoperative patient morbidity. Secondary outcomes were patient-reported satisfaction and hospital length of stay. Other variables assessed included demographics, procedure, operative time, estimated blood loss, and mortality. Patients also completed a validated satisfaction instrument 2 weeks after hospital discharge. RESULTS: Patients were equally distributed based on the baseline demographic and operative measures. Morbidity rates were similar between the study arms (standard rounds vs telerounds: 16% vs 13%; P = .64). Length of stay was similar in both arms (standard rounds vs telerounds: 2.8 vs 2.8 days; P = .94). In addition, patient satisfaction was equivalently high in both arms of the study. CONCLUSIONS: Robotic telerounds matched the performance of standard bedside rounds after urologic surgical procedures. Virtual visits did not result in missed or increased postoperative complications. Hospital length of stay and ratings of hospital satisfaction were on par with those for traditional rounding.

Computer modeling technology to assess extracapsular tissue coverage of whole mount sections after retropubic and laparoscopic radical prostatectomy.

PURPOSE: The introduction of new surgical approaches to radical prostatectomy requires methodologies that permit valid comparison that are more expedient than long-term outcomes of biochemical local and distant failure and survival. We used a computer modeling program to assess the percent of extracapsular tissue coverage of prostate glands removed by the open retropubic and laparoscopic approaches. MATERIALS AND METHODS: Specimens were available for 15 and 17 patients who underwent open and laparoscopic radical prostatectomy, respectively. Serial whole mount sections were taken at 5 mm intervals. A genitourinary pathologist drew the contours of the prostate capsule on each tissue section. The whole mount was scanned to produce digital images. A software program was used to create a file with capsule information and a file with extraprostatic fibroadipose tissue information. Two separate point cloud files were generated to represent the capsule and extraprostatic models, and software algorithms were used to generate differences in the point clouds to quantify the extent of extracapsular tissue coverage. RESULTS: When separated into sides dissected by a nerve or nonnerve sparing technique, the overall percent of gland surface coverage by extracapsular fibroadipose tissue was statistically greater with laparoscopic dissection than with the open approach. When a segmental analysis of gland coverage was evaluated, a statistically greater percent of fibroadipose coverage was associated with laparoscopic dissection in the apical and inferolateral segments with nonnerve sparing, and in the apical segment with nerve sparing. CONCLUSIONS: This small radical prostatectomy series, analyzed by computer reconstruction as described, provides information suggesting that overall extracapsular tissue coverage is at least equal if not superior using the laparoscopic vs the open approach. This was specifically the case in areas of inferolateral and apical dissection with nonnerve sparing procedures and in areas of the apical dissection with nerve sparing procedures.

Single center experience with third-generation cryosurgery for management of organ-confined prostate cancer: critical evaluation of short-term outcomes, complications, and patient quality of life.

BACKGROUND AND PURPOSE: Technical refinements such as improved ultrasonographic localization and the routine use of urethral warmers and small-gauge needle delivery systems have renewed interest in cryosurgical treatment as a minimally invasive option for selected patients with localized prostate cancer. Only three reports of quality of life (QoL) in prostate cryoablation exist, and none report on patients treated with third-generation cryoablative technology. We critically examine our initial series of consecutive patients at a single institution undergoing primary third-generation cryosurgical treatment of localized prostate cancer with respect to treatment outcome, morbidity profile, and QoL parameters. To our knowledge, this is the first QoL report on third-generation cryoablation of the prostate. PATIENTS AND METHODS: We retrospectively review the records of 89 consecutive patients with median followup of 11 months (1-32) who have undergone third-generation cryosurgical ablation of the prostate as primary treatment for localized prostate cancer with intention to cure. Patients were risk stratified according to preprocedural parameters of prostate-specific antigen (PSA), clinical stage, and Gleason score. PSA trends were recorded and treatment effectiveness was observed using different definitions of biochemical failure. Charts were reviewed for postprocedure complications. Quality of life was measured prospectively using the University of California, Los Angeles, Prostate Cancer Index as well as American Urological Association symptom scores. We compare a percent of baseline score (%BS) for various domains between our series of patients treated with primary cryoablation with a series of patients undergoing brachytherapy for localized prostate cancer. RESULTS: Treatment success was defined by achievement of a PSA nadir of < or =0.1 ng/mL and by biochemical disease-free survival (BDFS) assessed with both a PSA threshold of < or =0.4 ng/dL over time and the American Society for Therapeutic Radiology and Oncology (ASTRO) definition of three consecutive rises in PSA. According to risk stratification, 86%, 81.5%, and 78% of low-, intermediate-, and high-risk patients, respectively, achieved a PSA nadir of < or =0.1 ng/mL. Overall, at 12 months follow-up, 94% of patients achieved BDFS using ASTRO criteria while 70% achieved BDFS using a PSA threshold of < or =0.4 ng/mL. With risk stratification, 74%, 70%, and 60% of low-, intermediate-, and high-risk patients, respectively, achieved BDFS defined by PSA threshold of < or =0.4 ng/mL. Complications were rare. The response rate for Health Related Quality of Life (HRQoL) questionnaires was 71% for cryoablation patients and 51% for brachytherapy patients. At 12 months follow-up, patients undergoing cryoablation on average achieved urinary and bowel domain scores comparable to baseline, but sexual domains remained well below baseline. When compared with a brachytherapy series with better baseline sexual function (P = 0.04) and urinary function (P = 0.03), cryotherapy patients experienced more negative impact on sexual function steadily for up to 12 months (P = 0.02). Urinary function was similar between the groups until 18 months, at which time cryoablation patients fared better (P = 0.01); this was sustained up to 24 months (P = 0.04). CONCLUSIONS: Treatment success with cryosurgery varies with definition; however, our results are comparable to other series with regard to short-term cancer control. Complication rates in this series of third-generation cryosurgical patients are low. QoL characteristics of third-generation cryoablation are similar to those described in second-generation cryoablation series. Compared with brachytherapy, cryotherapy results in less irritative and obstructive voiding symptoms in the early post-treatment period and may improve urinary function up to 24 months after treatment. In a small group of older patients with baseline erectile dysfunction undergoing cryoablation, sexual function returns to 20% of its baseline value with up to 12 months follow-up.

Robotically assisted radical laparoscopic prostatectomy in a patient with ectopic ureteral insertion into the prostate.

Robotically assisted laparoscopic radical prostatectomy (RaLRP) has become an alternative surgical treatment option for patients with localized prostate cancer. Rare anatomic variations result in modification of established techniques. We describe the first successful completion of RaLRP for localized prostate cancer in a patient with coexisting complete left ureteral duplication and ectopic insertion of the upper pole moiety ureter into the prostatic urethra. After standard radical prostate excision and vesicourethral anastomosis, the unique anatomy in this case required additional reconstructive maneuvers including construction of a Y-type conjoined ureteral anastomosis and ureteroneocystotomy. The procedure was safely completed without open conversion. Operative time was 420 min and EBL was 200 mL. Ureteral stents were removed in six weeks and IVP showed no evidence of obstruction. When faced with a ureteral anomaly, RaLRP can be safely completed. Robotic technology is helpful in performing additional delicate reconstructive maneuvers.

Prospective longitudinal comparative study of early health-related quality-of-life outcomes in patients undergoing surgical treatment for localized prostate cancer: a short-term evaluation of five approaches from a single institution.

BACKGROUND AND PURPOSE: Quality of life (QoL) issues are a vital concern for the majority of patients seeking therapeutic intervention once they are found to have prostate cancer. A prospective longitudinal comparison using validated QoL instruments is a valuable technique to evaluate outcome differences. We evaluated the short-term QoL changes from baseline of five surgical approaches for localized prostate carcinoma delivered at a single institution. PATIENTS AND METHODS: A prospective longitudinal survey of 719 patients with newly diagnosed prostate cancer was initiated in 2001. The surgical procedures performed during this time period were open radical prostatectomy (ORP), laparoscopic radical prostatectomy (LRP), da Vinci robotic prostatectomy (dVP), (103)Pd brachytherapy ((103)Pd), and prostate cryoablation (PCryo). An Institutional Review Board-approved questionnaire comprised of validated QoL instruments (UCLA Prostate Cancer Index and American Urological Association Symptom Index [SI]) was mailed to enrolled patients prior to their selected surgery and again at 1, 3, 6, 9, 12, 18, 24, and 36 months after therapy. A percent of baseline score calculation including data from all five treatment cohorts for follow-up months 1, 3, and 6 was compared within groups. Group I consisted of patients undergoing ORP, LRP, or dVP. Group II consisted of patients undergoing (103)Pd or PCryo. RESULTS: Between January 2000 and April 2005, 498 patients (69%) were enrolled who completed the baseline questionnaire and at least one follow-up survey at 1, 3, or 6 months. The mean patient age at ORP, LRP, dVP, (103)Pd, and PCryo was 59, 61, 60, 67, and 72 years, respectively. Within Group I, early recovery of sexual function (at 3 months) appeared to occur sooner after dVP (35% return to baseline [RTB]) than ORP (24% RTB) and LRP (21% RTB) (P = 0.03). No other significant differences were noted, and trends toward improvement were seen in all groups. Within Group II, PCryo (18% RTB) had a more negative impact on sexual function at 3 months than did 103Pd (63% RTB) (P = 0.007), although a significant difference in baseline sexual function was also noted (P = 0.001). Early urinary function (at 1 month) was better after (103)Pd (82% RTB) than PCryo (72%) (P = 0.05), but this difference was lost at 6 months. In addition, the irritative and obstructive symptoms evaluated by the AUA SI were significantly worse (P = 0.003) at 3 months after (103)Pd than after PCryo. CONCLUSIONS: Different surgical approaches for the treatment of localized prostate cancer affect the shortterm QoL results in different ways. Urinary, sexual, and bowel function and bother are affected to a similar degree by ORP, LRP, and dVP. In an older population, the tissue destruction resulting from PCryo appears to relieve obstructive and irritative urinary symptoms but at the sacrifice of sexual function compared with (103)Pd.

Laparoscopic radical prostatectomy: evaluation of specimen pathologic features to critically assess and modify surgical technique.

OBJECTIVES: To evaluate laparoscopic radical prostatectomy (LRP) specimens for pathologic stage and the malignant and benign surgical margin status to determine areas for improvement in surgical technique. LRP is gaining significant attention as a viable alternative to retropubic radical prostatectomy. METHODS: A total of 110 consecutive LRP specimens were retrospectively reviewed. A single experienced genitourinary pathologist examined all slides. In addition, exposure of benign glands at the inked margin was reported. Oncologic data were assessed by standard pathologic examination for stage, grade, and margin status. The pathologic data from year 1 (group 1, 52 patients) were compared with the data from subsequent years (group 2, 58 patients). RESULTS: The overall positive surgical margin rate was 18.2% (13.5% for pT2 disease). Benign parenchymal exposure was identified in 16 patients (14.5%). Six of these patients had concomitant negative surgical margins for cancer. The positive margin rate for patients with Stage pT2 disease was 22.2% in group 1 and 5.9% in group 2. The positive margin rate was 34.8%, 13.6%, and 13.8% for bilateral, unilateral, and non-nerve-sparing procedures, respectively. CONCLUSIONS: LRP offers comparable surgical margins to those of reported open prostatectomy series. Careful pathologic review provides feedback so that technique modifications can be implemented and the positive margin rates improved further. A low, but significant, positive margin or benign parenchymal exposure rate in pT2 disease indicates room for improvement in the surgical technique. The presence of benign glands at the inked margin is not routinely reported but does provide an additional parameter of surgical adequacy.

Modified running vesicourethral anastomosis after robotically assisted laparoscopic radical prostatectomy: use of solitary Lapra-Ty to secure posterior approximation.

OBJECTIVES: We describe a novel method of ensuring posterior approximation and preventing urinary leak during the running anastomosis of robotically assisted laparoscopic prostatectomy. METHODS: Two 3-0 Monocryl RB-1 sutures are tied end-to-end. The undyed suture is placed first at the 5-o'clock position on the bladder side outside-in and then through the urethra at the same location inside-out. Proceeding clockwise, the suture is placed twice more through both the bladder and the urethra. With gentle manipulation, the suture is cinched down to provide secure posterior approximation; however, if tension is released from the suture coming from the urethra, the approximation may loosen and could result in a potential "gap" and site for anastomotic leakage. To prevent potential loosening, tension is maintained on the stitch as a single Lapra-Ty is placed at the base of the suture as it leaves the urethra. When the tension is released, the posterior approximation is tightly maintained and the remaining anastomosis is completed. RESULTS: We have performed 110 robotically assisted laparoscopic prostatectomies. Six urinary leaks requiring prolonged catheterization were identified in our first 90 patients (6.7%). We have not experienced any urinary leakage or short-term complications in the subsequent 20 patients using this technique. CONCLUSIONS: We describe a novel technique to ensure secure posterior approximation during the vesicourethral anastomosis after robotically assisted laparoscopic prostatectomy. A single Lapra-Ty clip placed early during the anastomosis prevents potential "gaps" in the approximation that may be the source of troublesome leakage.

Endoscopic treatment of upper tract transitional cell carcinoma.

PURPOSE: To review the current literature and data describing primary endoscopic treatment of upper tract transitional cell carcinoma (TCC). MATERIALS AND METHODS: Published, peer-reviewed articles on ureteroscopic, percutaneous, and laparoscopic treatment of upper tract TCC were identified using the MEDLINE database. RESULTS: Nephroureterectomy has been considered the "gold standard" for upper tract TCC. Minimally invasive approaches, initially advocated for patients requiring a nephron sparing approach (i.e., solitary kidney or renal insufficiency) or those with significant comorbidities precluding definitive surgery, have been increasingly used with the further refinement of ureteroscopy, percutaneous renal surgery, and laparoscopy. Ureteroscopy has been used successfully, resulting in recurrence rates ranging from 31% to 65% and disease-free rates of 35% to 86%. Progression and metastatic rates are low and correlate with tumor grade. Likewise, percutaneous approaches show disease specific survival and recurrence rates correlating with tumor grade. Patients with low-grade tumors (Grades 1-2) do well with this approach with recurrence rates and disease specific survival rates of 26% to 28% and 96% to 100%, respectively. For those patients requiring complete extirpation of the kidney and ureter, laparoscopic nephroureterectomy results in decreased postoperative pain, shorter hospital stay, and more rapid convalescence without compromising cancer control. CONCLUSIONS: Nephron sparing approaches in well-selected patients with low stage and low-grade disease can be treated endoscopically with ureteroscopy and percutaneous renal surgery. Laparoscopic nephroureterectomy offers a safe, minimally invasive alternative to traditional open surgical techniques for patients with TCC of the upper urinary tract.

Prospective longitudinal comparative study of health-related quality of life in patients undergoing invasive treatments for localized prostate cancer.

BACKGROUND AND PURPOSE: Health-related quality of life (QoL) concerns are important for patients selecting treatment options for clinically localized prostate cancer and are critical in evaluating outcomes. We report pretreatment and post-treatment general and disease-specific QoL for the following invasive interventions: open radical prostatectomy (ORP), laparoscopic radical prostatectomy (LRP), and palladium-103 ((103)Pd) brachytherapy. PATIENTS AND METHODS: We performed a prospective longitudinal survey of 452 patients with newly diagnosed prostate cancer treated at a single medical center between 2001 and 2003. An Institutional Review Board-approved questionnaire comprised of validated QoL instruments was sent to patients scheduled to undergo ORP (N = 186), LRP (N = 116), or brachytherapy (N = 150). The same questionnaire was sent out 1, 3, 6, 9, and 12 months after therapy. Comparisons were made between the groups to determine if the choice of therapy resulted in differences in QoL. RESULTS: General QoL scores were minimally affected by the choices; however, the disease-specific domains of bowel, urinary, and sexual function were adversely affected by all modalities. The ORP and LRP groups were similar among disease-specific domains and received lower post-treatment urinary and sexual scores than the (103)Pd patients. At 12 months, 38% of ORP and 46% of LRP patients had returned to baseline urinary function compared with 75% of (103)Pd patients. At 12 months, 63% of (103)Pd patients had returned to baseline sexual function compared with 19% of both the LRP and ORP patients. CONCLUSIONS: Invasive treatments for localized prostate cancer have little impact on general QoL but significantly affect disease-specific domains. Both ORP and LRP have a greater initial negative impact on urinary and sexual function than (103)Pd. The differences among the treatments with regard to QoL provide information to patients faced with choosing a treatment.

Misattributed paternity in a living related donor: to disclose or not to disclose?

Many ethical considerations surround living kidney donation, some of which are not anticipated. We present a case in which misattributed paternity was inadvertently discovered during the workup of a father and son and present arguments for and against disclosure of this information. We recommend that transplant programs advise patients participating in living organ donor programs that misattributed paternity might be discovered during routine preoperative testing and that protocols for dealing with complex ethical issues be in place.

Ureteropelvic junction obstruction: does CT angiography allow better selection of therapeutic modalities and better patient outcome?

PURPOSE: To determine whether preoperative helical CT angiography (CTA) with three-dimensional (3D) reconstructed images improves outcome in patients with ureteropelvic junction obstruction (UPJO) by identifying crossing vessels that may lead to surgical failure. PATIENTS AND METHODS: Twenty-five patients with UPJO underwent imaging with CTA to identify crossing vessels. Patients with crossing vessels or severe hydronephrosis underwent laparoscopic dismembered pyeloplasty. In the absence of crossing vessels, and with >25% renal function on MAG-3 scan, the patient underwent an endopyelotomy. Procedures were assessed as successful by resolution of patient symptoms as well as relief of obstruction on renal scintography. RESULTS: Twenty-seven procedures (14 laparoscopic dismembered pyeloplasties [9 in the setting of a crossing vessel], 11 ureteroscopic endopyelotomies, and two antegrade endopyelotomy procedures) were performed. Follow-up ranged from 2.4 to 40 months (mean 21.6 months). Twenty-three of the primary procedures (92.0%) were successful. Primary laparoscopic pyeloplasty was successful in 100% of patients, while primary endopyelotomy had a success rate of 83.3%. Both secondary procedures were successful rendering the patients unobstructed and pain free. No complications occurred. The sensitivity and specificity of CTA in determining crossing vessels was 78% and 40%, respectively. CONCLUSIONS: Helical CT angiography with 3D reconstructed images provides valuable preoperative information in patients with UPJO scheduled for surgical intervention. This study may be used in selecting patients for proper operative intervention according to the anatomy of crossing vessels to attain high treatment success rates.