Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy and Docetaxel in Black Patients From the Randomized ARASENS Trial.

BACKGROUND: In the ARASENS trial (NCT02799602), darolutamide in combination with androgen-deprivation therapy (ADT) and docetaxel significantly reduced the risk of death by 32.5% (HR, 0.68; 95% CI, 0.57-0.80; P < .0001) compared with placebo plus ADT with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC). We present efficacy and safety of darolutamide versus placebo in Black patients from ARASENS. PATIENTS AND METHODS: Patients with mHSPC were randomized 1:1 to darolutamide 600 mg or placebo twice daily in combination with ADT and docetaxel. The primary endpoint was overall survival. Key secondary endpoints included time to castration-resistant prostate cancer (CRPC) and safety. RESULTS: In ARASENS, 54 Black patients received darolutamide (n = 26) or placebo (n = 28) plus ADT and docetaxel. In Black patients, overall survival favored darolutamide versus placebo (median, not reached vs. 38.7 months; stratified HR, 0.41; 95% CI, 0.17-1.02), with 4-year survival rates of 62% versus 41%. The darolutamide group also had longer time to CRPC compared with the placebo group (median, not reached vs .12.6 months; HR, 0.09; 95% CI, 0.02-0.30). The safety profile of darolutamide in Black patients was consistent with that observed for the overall ARASENS population (grade 3/4 treatment-emergent adverse events, TEAEs: 61.5% vs. 66.1%; serious TEAEs: 42.3% vs. 44.8%). CONCLUSION: In this small population of Black patients with mHSPC from the ARASENS trial, darolutamide was associated with an improvement in survival and time to CRPC and was well tolerated. Efficacy and safety findings in Black patients were consistent with the overall ARASENS population.

Drug-drug interaction potential among patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) treated with novel androgen receptor inhibitors.

BACKGROUND: Nonmetastatic castration-resistant prostate cancer (nmCRPC) patients are often older and use concurrent medications that increase the potential for drug-drug interactions (pDDIs). This study assessed pDDI prevalence in real-world nmCRPC patients treated with apalutamide, darolutamide, or enzalutamide. RESEARCH DESIGN AND METHODS: Castrated prostate cancer patients without metastases prior to androgen receptor inhibitor initiation were identified retrospectively via Optum Clinformatics Data Mart claims data (8/2019-3/2021). The top 100 concomitant medications were assessed for pDDIs. RESULTS: Among 1,515 patients (mean age: 77 ± 8 years; mean Charlson Comorbidity Index: 3 ± 3), 340 initiated apalutamide, 112 darolutamide, and 1,063 enzalutamide. Common concomitant medication classes were cardiovascular (80%) and central nervous system (52%). Two-thirds of the patients received ≥5 concomitant medications; 30 (30/100 medications) pDDIs were identified for apalutamide and enzalutamide each and 2 (2/100 medications) for darolutamide. Most pDDIs had risk ratings of C or D, but four for apalutamide were rated X. Approximately 58% of the patients on apalutamide, 5% on darolutamide, and 54% on enzalutamide had ≥1 identified pDDI. CONCLUSIONS: Results showed a higher frequency of pDDIs in patients receiving apalutamide and enzalutamide vs darolutamide. The impact of these could not be determined retrospectively. DDI risk should be carefully evaluated when discussing optimal therapy for patients with nmCRPC.

Necrotizing granulomatous epididymo-orchitis post intravesical BCG administration after brachytherapy for prostate cancer.

Urothelial carcinoma of the bladder remains a challenging disease to treat. Intravesical instillation of BCG has demonstrated tremendous efficacy in preventing recurrence. BCG related necrotizing granulomatous epididymo-orchitis is rare and has not been previously linked to brachytherapy for adenocarcinoma of the prostate. We hypothesize that prior brachytherapy has a deleterious effect on the verumontanum that can result in retrograde transmission of BCG particles leading to granulomatous epididymo-orchitis. This is the first case report of necrotizing granulomatous epididymo-orchitis related to BCG in a patient status post brachytherapy for adenocarcinoma of the prostate.

Deep and Durable Prostate-specific Antigen Response to Darolutamide with Androgen Deprivation Therapy and Docetaxel, and Association with Clinical Outcomes for Patients with High- or Low-volume Metastatic Hormone-sensitive Prostate Cancer: Analyses of the Randomized Phase 3 ARASENS Study.

BACKGROUND AND OBJECTIVE: Addition of darolutamide to androgen deprivation therapy (ADT) and docetaxel significantly improved overall survival (OS) in ARASENS (NCT02799602). Here we report on prostate-specific antigen (PSA) responses and their association with outcomes. METHODS: ARASENS is an international, double-blind, phase 3 study in patients with metastatic hormone-sensitive prostate cancer (mHSPC) randomized to darolutamide 600 mg orally twice daily (n = 651) or placebo (n = 654), both with ADT + docetaxel. The proportion of patients with undetectable PSA (<0.2 ng/ml) and time to PSA progression (≥25% relative and ≥2 ng/ml absolute increase from nadir) were compared between groups in prespecified exploratory analyses. PSA outcomes by disease volume and the association of undetectable PSA with OS and times to castration-resistant prostate cancer (CRPC) and PSA progression were assessed in post hoc analyses. KEY FINDINGS AND LIMITATIONS: The proportion of patients with undetectable PSA at any time was more than doubled with darolutamide versus placebo, at 67% versus 29% in the overall population, 62% versus 26% in the high-volume subgroup, and 84% versus 38% in the low-volume subgroup. Darolutamide delayed time to PSA progression versus placebo, with hazard ratios of 0.26 (95% confidence interval [CI] 0.21-0.31) in the overall population, 0.30 (95% CI 0.24-0.37) in the high-volume subgroup, and 0.093 (95% CI 0.047-0.18) in the low-volume subgroup. Undetectable PSA at 24 wk was associated with longer OS, with a hazard ratio of 0.49 (95% CI 0.37-0.65) in the darolutamide group, as well as longer times to CRPC and PSA progression, with similar findings in the disease volume subgroups. CONCLUSIONS AND CLINICAL IMPLICATIONS: Darolutamide + ADT + docetaxel led to deep and durable PSA responses in patients with high- or low-volume mHSPC. Achievement of undetectable PSA (<0.2 ng/ml) was correlated with better clinical outcomes. PATIENT SUMMARY: For patients with metastatic hormone-sensitive prostate cancer being treated with androgen deprivation therapy and docetaxel, PSA (prostate-specific antigen) became undetectable (below 0.2 ng/ml) in 67% of those also receiving darolutamide versus 29% of patients also receiving placebo. On average, patients achieving undetectable PSA lived longer than patients with detectable PSA.

Survival Outcomes by Race and Ethnicity in Veterans With Nonmetastatic Castration-Resistant Prostate Cancer.

Importance: Racial and ethnic disparities in prostate cancer are poorly understood. A given disparity-related factor may affect outcomes differently at each point along the highly variable trajectory of the disease. Objective: To examine clinical outcomes by race and ethnicity in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) within the US Veterans Health Administration. Design, Setting, and Participants: A retrospective, observational cohort study using electronic health care records (January 1, 2006, to December 31, 2021) in a nationwide equal-access health care system was conducted. Mean (SD) follow-up time was 4.3 (3.3) years. Patients included in the analysis were diagnosed with prostate cancer from January 1, 2006, to December 30, 2020, that progressed to nmCRPC defined by (1) increasing prostate-specific antigen levels, (2) ongoing androgen deprivation, and (3) no evidence of metastatic disease. Patients with metastatic disease or death within the landmark period (3 months after the first nmCRPC evidence) were excluded. Main Outcomes and Measures: The primary outcome was time from the landmark period to death or metastasis; the secondary outcome was overall survival. A multivariate Cox proportional hazards model, Kaplan-Meier estimates, and adjusted survival curves were used to evaluate outcome differences by race and ethnicity. Results: Of 12 992 patients in the cohort, 826 patients identified as Hispanic (6%), 3671 as non-Hispanic Black (28%; henceforth Black), 7323 as non-Hispanic White (56%; henceforth White), and 1172 of other race and ethnicity (9%; henceforth other, including American Indian or Alaska Native, Asian, Native Hawaiian or Other Pacific Islander, unknown by patient, and patient declined to answer). Median time elapsed from nmCRPC to metastasis or death was 5.96 (95% CI, 5.58-6.34) years for Black patients, 5.62 (95% CI, 5.11-6.67) years for Hispanic patients, 4.11 (95% CI, 3.96-4.25) years for White patients, and 3.59 (95% CI, 3.23-3.97) years for other patients. Median unadjusted overall survival was 6.26 (95% CI, 6.03-6.46) years among all patients, 8.36 (95% CI, 8.0-8.8) years for Black patients, 8.56 (95% CI, 7.3-9.7) years for Hispanic patients, 5.48 (95% CI, 5.2-5.7) years for White patients, and 4.48 (95% CI, 4.1-5.0) years for other patients. Conclusions and Relevance: The findings of this cohort study of patients with nmCRPC suggest that differences in outcomes by race and ethnicity exist; in addition, Black and Hispanic men may have considerably improved outcomes when treated in an equal-access setting.

Marital status: a gender-independent risk factor for poorer survival after radical cystectomy.

UNLABELLED: Study Type - Prognosis (cohort) Level of Evidence 2a. What's known on the subject? and What does the study add? Married individuals have lower morbidity and mortality rates for all major causes of death. Cancer-specific survival is better in married patients with testis cancer, prostate cancer, breast cancer, cervical cancer, as well as head and neck cancers. We have found the effect of marital status on outcomes after radical cystectomy to be variable, depending on gender and the outcome addressed. Being married is predictive of lower all-cause mortality for both men and women relative to their separated, divorced or widowed (SDW) or never-married counterparts. It is also predictive of lower bladder-cancer-specific mortality relative to SDW individuals. Marriage also exerts a protective effect on men regarding non-organ-confined disease, with those never having married having significantly higher rates. OBJECTIVES: • To examine the effect of marital status (MS) on the rate of non-organ-confined disease (NOCD) at radical cystectomy (RC) • To assess the effect of MS on the rate of bladder-cancer-specific mortality (BCSM) and all-cause mortality (ACM) after RC for urothelial carcinoma of the urinary bladder (UCUB). MATERIALS AND METHODS: • A total of 14 859 patients, who underwent RC for UCUB, were captured within the Surveillance, Epidemiology, and End Results database, between 1988 and 2006. • Logistic regression analysis was used to assess the rate of NOCD (T(3-4) /N(I-3) /M(0) ) at RC and Cox regression analyses were used to assess BCSM and ACM. • Analyses were stratified according to gender; covariates included socio-economic status, tumour stage, age, race, tumour grade and year of surgery. RESULTS: • Never-married males had a higher rate of NOCD at RC (odds ratio = 1.22, P= 0.004), an effect not found in never-married females. • Separated, divorced or widowed (SDW) males (hazard ratio [HR]= 1.18, P= 0.005) and females (HR = 1.16, P= 0.002) had higher rates of BCSM than their married counterparts. • SDW and never-married males had higher rates of ACM than their married counterparts (HR = 1.22, P < 0.001 and HR = 1.26, P < 0.001, respectively). • SDW and never-married females also had higher rates of ACM than married females (HR = 1.24, P < 0.001 and HR = 1.22, P= 0.01, respectively). CONCLUSIONS: • For both men and women, being SDW conveyed an increased risk of BCSM after RC. • SDW and never marrying had a deleterious effect on ACM. • Unfavourable stage at RC was also seen more commonly in never-married males.

Review of current varicocelectomy techniques and their outcomes.

OBJECTIVES: • To review all the various techniques and their results and efficiencies to provide practicing urologists with some guidance for choice of technique • To discuss improvements of varicocelectomy techniques in the last 15 years and their impact on results of surgery. PATIENTS AND METHODS: • A PubMed English literature review of literature from 1995 to present. RESULTS: • Pregnancy rates were highest with microsurgical subinguinal technique • Varicocele recurrence rates were lowest with microsurgical subinguinal technique • Hydrocele formation rates were lowest with microsurgical inguinal technique • Surgical complications were highest in the laparoscopic technique • Varicocelectomy by itself or in conjunction with IVF is cost effective CONCLUSIONS: • Microsurgical subinguinal or microsurgical inguinal techniques offer best outcomes • Varicocelectomy is a cost effective treatment modality for infertility • Further research is needed to explore new developments in varicocelectomy.

The Economic Burden of Nocturia on the U.S. Health Care System and Society: A National Health and Nutrition Examination Survey Analysis.

BACKGROUND: Nocturia, characterized as waking during the main sleep period to urinate, is a common condition. Persistent nocturia results in sleep fragmentation with deleterious effects on health and well-being. Yet, there are limited data on the economic burden of nocturia in the United States. OBJECTIVE: To assess the association of nocturia with health care resource utilization (HRU), work productivity, and self-rated health while estimating the societal costs of nocturia in the United States in 2017. METHODS: A retrospective cross-sectional study was conducted using data from the National Health and Nutrition Examination Survey (NHANES; 2005-2006 to 2013-2014). Adults aged ≥ 18 years (excluding pregnant women) were stratified into individuals with nocturia (≥ 2 voids/night) and individuals without nocturia (< 2 voids/night), based on the threshold for clinically significant nocturia. Outcomes were self-reported and included HRU (hospitalizations, outpatient visits); work productivity (weekly hours worked, employment); and current health status. Multivariable regression analyses adjusting for age, race, sex, body mass index, insurance status, education level, alcohol use, smoking status, and self-reported comorbid conditions were used to compare the 2 cohorts, overall and stratified by age group (20-44 years, 45-64 years, and 65+ years) to distinguish the effects on different age groups including the Medicare-aged population. Excess direct health care costs and indirect productivity costs associated with nocturia in the United States were then calculated using a prevalence-based approach and available literature (i.e., nocturia prevalence estimates, aggregated unit costs by HRU type, and average hourly earnings in the United States). RESULTS: 22,300 individuals were identified, and 24% had nocturia (≥ 2 voids/night). Median age was 55.2 and 43.2 years among individuals with and without nocturia, respectively, and the proportion of males was 43.3% and 51.3%, respectively. Individuals with nocturia had significantly more HRU, including hospitalizations and outpatient visits, worked significantly fewer hours weekly, and were significantly less likely to be employed when compared with those without nocturia. They were also significantly less likely to report being in very good/excellent health. These comparisons remained statistically significant across age groups. Total excess direct health care costs were $62.9 billion (hospitalization: $47.6 billion; outpatient: $15.3 billion). Total excess indirect productivity costs were $151.7 billion. Altogether, costs were estimated at $214.5 billion, equivalent to $3,491 per individual with nocturia. Individuals aged 20-44 years incurred 23.5% of total excess costs, while those aged 45-64 and 65+ years incurred 48.2% and 28.3%, respectively. Sensitivity analyses based on lower prevalence estimates resulted in costs of $94.0 billion, while those based on higher prevalence estimates reached up to $231.1 billion. CONCLUSIONS: Nocturia is associated with a substantial economic burden in the United States even when evaluated based on lower prevalence estimates. This study underscores the importance of timely diagnosis and management of nocturia patients to alleviate health-related and economic consequences to patients and society. DISCLOSURES: This work was supported by Ferring Pharmaceuticals, which contributed to and approved the study design and participated in the interpretation of data, review, and approval of the manuscript. Gauthier-Loiselle, Gagnon-Sanschagrin, and Wu are employees of Analysis Group, which received consultancy fees from Ferring Pharmaceuticals for work on this study. Jhaveri is a full-time employee of Ferring Pharmaceuticals. Parts of this work were presented as a poster presentation at AMCP Nexus 2018; October 22-25, 2018; Orlando, FL.

Surgical technique to overcome anatomical shortcoming: balancing post-prostatectomy continence outcomes of urethral sphincter lengths on preoperative magnetic resonance imaging.

PURPOSE: Shorter urethral sphincter length on preoperative endorectal magnetic resonance imaging has been associated with an increased risk of postoperative urinary incontinence as well as longer time to achieve continence. We determined that our techniques of anatomical reconstruction for restoring the continence mechanism could markedly improve continence outcomes, especially in patients with a shorter urethral sphincter. MATERIALS AND METHODS: Our cohort consisted of 274 patients who underwent robotic radical prostatectomy, as performed by a single surgeon, and for whom preoperative magnetic resonance imaging and postoperative evaluations were available. All sphincter lengths were measured on T2-weighted images as the distance from the prostatic apex to the penile bulb, cross-referencing all 3 planes. Continence was defined as zero pads or a liner used for security reasons only. RESULTS: The 2 surgical modifications considerably hastened the return of continence at 6 months. The continence rate in the shorter sphincter group (less than 14 mm) was 47% for the control technique, 81% for anterior reconstruction and 90% for total reconstruction. The continence rate in the longer sphincter group (more than 14 mm) was 80% for the control technique and 83% for anterior reconstruction, while it approached 99% for total reconstruction. With the control technique the average time to achieve continence was significantly different between the shorter and longer sphincter groups (25 vs 12 weeks, p = 0.037). The significance disappeared for anterior reconstruction (7.4 vs 6.2 weeks, p = 0.27) and total reconstruction (3.6 vs 2.7 weeks, p = 0.13). CONCLUSIONS: The results of this study are encouraging for patients with a short urethral sphincter who are considering radical prostatectomy.

Total reconstruction of the vesico-urethral junction.

OBJECTIVE: We describe a novel technique of total vesico-urethral reconstruction, which combines the tactics of previous surgeons, and compare the outcome of our innovative changes for return to early continence with prostatectomies with no or partial reconstruction of the vesico-urethral junction. PATIENTS AND METHODS: Between 1 January 2005 and 5 June 2007 a cohort of 700 patients undergoing robotic radical prostatectomy were prospectively evaluated. Patients in 2005 (214) served as a control group, they received no additional methods to provide support to the vesico-urethral junction; a standard anastomosis was made. Patients in 2006 (304) received an anterior reconstruction only, to provide additional vesico-urethral anastomotic support. Patients in 2007 (182) received the total reconstructive procedure, which included an anterior reconstruction and posterior reconstruction. Outcome data were collected using standardized health-related quality-of-life measures, which included the Expanded Prostate Cancer Index Composite survey, International Prostate Symptom Score, International Index of Erectile Function, and then re-verified by telephone interview with a standardized questionnaire. The follow-up intervals were 1, 6, 12, 24 and 52 weeks. Continence was defined as no pad usage or one small liner used for security purposes only. Baseline variables were also collected. RESULTS: The percentage of patients who had achieved continence in the control group were: 13%, 35%, 50%, 62% and 82% at the 1-, 6-, 12-, 24- and 52-week follow-up, respectively. The percentage of patients who had achieved continence in the anterior reconstruction group were 27%, 59%, 77%, 86%, and 91%, respectively. The total reconstruction group had continence rates of 38%, 83%, 91%, and 97% at 1, 6, 12, and 24 weeks, respectively. At all the follow-up intervals the continence rate was significantly less in the control group than in the anterior reconstruction group and the total reconstruction group (P < 0.01). CONCLUSIONS: The total reconstruction procedure is a safe and effective way to achieve an early return to continence. No adverse effects have been observed because of its employment and our data validates that it does provide a statistically significant early return to continence compared with no reconstructive efforts or with only anterior reconstructive efforts.

Pneumonia after Major Cancer Surgery: Temporal Trends and Patterns of Care.

Rationale. Pneumonia is a leading cause of postoperative complication. Objective. To examine trends, factors, and mortality of postoperative pneumonia following major cancer surgery (MCS). Methods. From 1999 to 2009, patients undergoing major forms of MCS were identified using the Nationwide Inpatient Sample (NIS), a Healthcare Cost and Utilization Project (HCUP) subset, resulting in weighted 2,508,916 patients. Measurements. Determinants were examined using logistic regression analysis adjusted for clustering using generalized estimating equations. Results. From 1999 to 2009, 87,867 patients experienced pneumonia following MCS and prevalence increased by 29.7%. The estimated annual percent change (EAPC) of mortality after MCS was -2.4% (95% CI: -2.9 to -2.0, P < 0.001); the EAPC of mortality associated with pneumonia after MCS was -2.2% (95% CI: -3.6 to 0.9, P = 0.01). Characteristics associated with higher odds of pneumonia included older age, male, comorbidities, nonprivate insurance, lower income, hospital volume, urban, Northeast region, and nonteaching status. Pneumonia conferred a 6.3-fold higher odd of mortality. Conclusions. Increasing prevalence of pneumonia after MCS, associated with stable mortality rates, may result from either increased diagnosis or more stringent coding. We identified characteristics associated with pneumonia after MCS which could help identify at-risk patients in order to reduce pneumonia after MCS, as it greatly increases the odds of mortality.

Ureteral injuries sustained during robot-assisted radical prostatectomy.

BACKGROUND AND PURPOSE: During the last decade, the annual volume of robot-assisted prostatectomies performed in the United States has risen steadily. Refinements in surgical technique, understanding of anatomy, and experience have led to more complex patients being offered surgery for management of organ-confined prostate cancer. Complication rates of robot-assisted prostatectomy have been reported in several articles; however, a paucity of data exists when evaluating ureteral injuries sustained during robot-assisted prostatectomy. No standardized universal criteria for reporting and grading of complications exists; therefore, the Martin-Donat criteria with Clavien-Dindo classification system were used to evaluate ureteral injuries in our series. PATIENTS AND METHODS: From January 2001 to June 2013, 6442 consecutive patients were treated with robot-assisted prostatectomy at the same institution by one of five surgeons. All complications were documented through a prospectively maintained prostate cancer database with supplementation from electronic medical records, operative and nursing notes, claims data, discharge summaries, outpatient and emergency visits, institutional morbidity and mortality data, as well as National Surgical Quality Improvement Program data. The Martin-Donat criteria were used to facilitate the accurate and comprehensive reporting of surgical complications while complication severity was assigned following the Clavien-Dindo classification system. RESULTS: Three patients sustained ureteral injuries (ureteral transection) in our series. Both surgeons were beyond their learning curve (greater than 1000 cases) when the injuries occurred; one patient needed readmission, and all patients had risk factors predisposing them to ureteral injury. Each patient was managed with robot-assisted ureteroneocystostomy (1), open transureteroureterostomy (1) and robot-assisted ureteroureterostomy (1) respectively. CONCLUSIONS: Ureteral injuries are uncommon; however, thorough preoperative evaluation and surgical planning could identify patients at high risk for sustaining ureteral injury during prostatectomy. Measures can be taken preoperatively or intraoperatively to reduce the probability of ureteral injury, eliminating the necessity for additional procedures postoperatively.

Variations in the quality of care at radical prostatectomy.

Postoperative morbidity and mortality is low following radical prostatectomy (RP), though not inconsequential. Due to the natural history of the disease process, the implications of treatment on long-term oncologic control and functional outcomes are of increased significance. Structures, processes and outcomes are the three main determinants of quality of RP care and provide the framework for this review. Structures affecting quality of care include hospital and surgeon volume, hospital teaching status and patient insurance type. Process determinants of RP care have been poorly studied, by and large, but there is a developing trend toward the performance of randomized trials to assess the merits of evolving RP techniques. Finally, the direct study of RP outcomes has been particularly controversial and includes the development of quality of life measurement tools, combined outcomes measures, and the use of utilities to measure operative success based on individual patient priority.

Optimizing vesicourethral anastomosis healing after robot-assisted laparoscopic radical prostatectomy: lessons learned from three techniques in 1900 patients.

BACKGROUND AND PURPOSE: Creation of an optimally apposed, tension-free, well-supported vesicourethral anastomosis remains the cornerstone for anastomotic healing after radical prostatectomy. We report the effect of three techniques of bladder neck reconstruction during robot-assisted radical prostatectomy on anastomotic leak, stricture formation, and continence recovery. PATIENTS AND METHODS: Between January 2005 to September 2009, 1900 consecutive patients underwent robotic-assisted laparoscopic prostatectomy (RALP) by a single surgeon. Of these, the first 214 underwent vesicourethral conventional anastomosis (CA); the next 303 men underwent anterior reconstruction (AR) only; and last 1383 men underwent total anatomic restoration (TR). Data elements included patient age, body mass index, preoperative biopsy Gleason score and prostate-specific antigen level, prostate volume, total operative time, console time, time for performing vesicourethral anastomosis, estimated blood loss, tumor stage, and margin status on final pathologic findings. Primary end points were rates of clinically significant anastomotic leaks, bladder neck contractures, and time to return of continence. Chi-square and Fisher exact tests were used for analysis of categoric variables. The Cox proportional hazard model was used for both univariate and multivariate analysis. RESULTS: Clinically significant anastomotic leakage and bladder neck strictures were significantly fewer in the reconstructed groups (2.3% vs 1.0% vs 0.3% and 3.7% vs 1.3% vs 0.5% in the CA, AR, and TR groups, P < 0.01). Continence rates at 1, 6, 12, 26, and 52 weeks after RALP were also significantly better at all time points with AR and TR compared with CA alone (P < 0.001). CONCLUSIONS: TR of the continence mechanism optimizes vesicourethral anastomosis healing and hastens early continence return after RALP.

Prostate volume and the incidence of extraprostatic extension: is there a relation?

BACKGROUND AND PURPOSE: Extraprostatic extension (EPE) of tumor is an important prognostic indicator that has an impact on long-term survival after radical prostatectomy. We investigated whether the prostate size has any association with the tumor volume and the incidence of EPE. PATIENTS AND METHODS: Seven hundred consecutive robot-assisted radical prostatectomy procedures performed by a single surgeon at a single center were studied. Preoperative parameters (demographic details, prostate-specific antigen (PSA) level, biopsy characteristics, and tumor volume) and the postoperative histopathologic details of the specimen (prostate volume, Gleason sum, EPE, and surgical margin status) were compared among the small prostate (< 40 cc), intermediate size (40-70 cc), and large prostate (> 70 cc) groups. Chi-square analysis was performed for comparison of groups with nominal variables while continuous variables were compared using analysis of variance. A double-sided P value of less than 0.05 was considered statistically significant. RESULTS: A greater proportion of patients in the large prostate group had T(1c) tumor compared with those in the small prostate group (90.2% v 78.3%). Younger men and smaller prostates had lower preoperative PSA levels (P < 0.001). A significantly higher PSA density (0.16 v 0.07) and cancer density (0.0102 v 0.0025), however, was observed in patients with small prostates compared with those with large prostates. A total of 102 (14.6%) patients had EPE on the final pathologic analysis while 8.6% of the patients had positive surgical margins. Greater incidence of EPE was observed in the group with smaller prostates compared to those in the large prostate group (16.7% v 7.3%). CONCLUSION: Small prostates have a higher cancer density and a greater incidence of EPE of tumor.

Double-pigtail stenting of the ureters: technique for securing the ureteral orifices during robot-assisted radical prostatectomy for large median lobes.

Patients with large median prostate lobes undergoing robot-assisted radical prostatectomy are at potential risk of ureteric orifice injury, during posterior bladder neck transection and vesicourethral anastomosis reconstruction. We describe our technique of in situ robot-assisted ureteral stenting with double-pigtail stents for accurate observation and preservation of the ureteral orifices. We have performed this maneuver in over 30 patients in our cohort of over 1500 patients undergoing robot-assisted radical prostatectomy to date--none of these patients developed urinary leak or bladder neck contracture, and had uneventful cystoscopic removal of stents at 6 weeks after surgery.

Robot-assisted laparoscopic radical prostatectomy in the renal allograft transplant recipient.

BACKGROUND AND PURPOSE: Since the advent of immunosuppressive therapy, patients have been able to lead longer lives as transplant recipients. We report the first case of robot-assisted laparoscopic prostatectomy in the renal allograft recipient. PATIENTS AND METHODS: A 54-year-old man presented with Gleason 3+3 localized prostate cancer with a prostatespecific antigen level of 8.5 ng/mL. He had a history of end-stage renal failure secondary to fulminant acute pyelonephritis necessitating bilateral nephrectomy. Renal allograft transplant in the right iliac fossa was performed in 1981, with adequate renal function while continuing his immunosuppressant regime. The patient also had previous left inguinal herniorrhaphy. Modifications to our surgical approach include placement of a bariatric port superiolaterally to the standard port site; siting the left port inferiolaterally to provide adequate access for pelvic lymph node dissection; and developing the retropubic space largely from the contralateral side to avoid allograft injury. Extensive adhesiolysis was also needed. After negative urethral margin reported on frozen section, vesicourethral anastomosis was fashioned using our Cornell bladder neck anatomic reconstruction technique. RESULTS: The patient needed a postoperative transfusion of 1 unit of blood and was discharged on postoperative day 2 after recommencement of immunosuppression. The final pathology report revealed pT(2c) Gleason 7 (3+4) disease and negative surgical margins. Continence was recovered within the first week of catheter removal, and erections sufficient for penetration occurred before 6-week follow-up in the clinic. CONCLUSION: Robot-assisted radical prostatectomy is feasible in the carefully selected renal allograft recipient with favorable oncologic, continence, and potency outcomes.

Robotic prostatectomy: a review of outcomes compared with laparoscopic and open approaches.

Prostate cancer affects the lives of millions of Americans each year. Since the advent of prostate-specific antigen testing, many cancers are found in initial stages and have the potential for curative resection; however, choosing which type of surgery to undergo can be a difficult task. This article reviews the outcomes of robotic prostatectomy in comparison with laparoscopic or open procedures. A PubMed search was performed to identify specific articles describing intraoperative details, surgical complications, cancer control, and continence and potency outcomes. Articles that revealed pertinent data were included in this study comparing robotic with laparoscopic or open prostatectomies.