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Background: Previous research exploring the role of race on prostate cancer (PCa) outcomes has demonstrated greater rates of disease progression and poorer overall survival for African American (AA) compared to Caucasian American (CA) men. The current study examines self-reported race as a predictor of long-term PCa outcomes in patients with low and favorable-intermediate risk disease treated with external beam radiation therapy (EBRT)., Methods: This retrospective cohort study examined patients who were consented to enrollment in the Center for Prostate Disease Research Multicenter National Database between January 01, 1990 and December 31, 2017. Men self-reporting as AA or CA who underwent EBRT for newly diagnosed National Comprehensive Cancer Network-defined low or favorable-intermediate risk PCa were included. Dependent study outcomes included: biochemical recurrence-free survival, (ii) distant metastasis-free survival, and (iii) overall survival. Each outcome was modeled as a time-to-event endpoint using race-stratified Kaplan-Meier estimation curves and multivariable Cox proportional hazards analysis., Results: Of 840 men included in this study, 268 (32%) were AA and 572 (68%) were CA. The frequency of biochemical recurrence, distant metastasis, and deaths from any cause was 151 (18.7%), 29 (3.5%), and 333 (39.6%), respectively. AA men had a significantly younger median age at time of EBRT and slightly higher biopsy Gleason scores. Multivariable Cox proportional hazards analyses demonstrated no racial differences in any of the study endpoints., Conclusions: These findings reveal no racial disparity in PCa outcomes for AA compared to CA men, in a long-standing, longitudinal cohort of patients with comparable access to cancer care., (© 2022 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Introduction: This document provides an update to the 2015 consensus statement with new content on inpatient utilization, procedural data, and compensation. The full document is available on the American Urological Association (AUA) website (https://www.auanet.org/guidelines/guidelines/current-state-of-advanced-practice-providers-in-urologic-practice). This document was created by an ad-hoc group of urological providers formed by the AUA board of directors., Methods: A workforce shortage of 65,000 physicians is projected by the year 2025. In 2018, there were 3.89 urologists per capita, which is amongst the most severe specialty shortages. Urology has the second oldest surgical subspecialty workforce with an average age of 52.5 years. According to the 2018 census, 72.5% of urologists used an advanced practice provider (APP) in their practice, and APPs accounted for 41% of a medical doctor/doctor of osteopathy full-time equivalent. The AUA endorses the use of APPs in the care of patients through a formally defined, supervised role with a board certified urologist under the auspices of applicable state law. This physician-led, team-based approach provides the highest quality urological care., Results: Urologists work with APPs frequently, but many may not know the most efficient way to incorporate them into their practice. This document examines APP integration from a regulatory and practice management approach, as well as provides information on inpatient utilization, procedural data, and compensation., Conclusions: This document supports the AUA's policy statement that in a team-based approach with a board certified urologist in a supervisory role, APPs contribute to the care of the patient with genitourinary disease and, therefore, encourages the proper use of APPs.

Introduction: Combined radiotherapy and hormonal treatment are recommended for intermediate- and high-risk prostate cancer (CaP). This study compared the long-term effects on health-related quality of life (HRQoL) of intermediate- and high-risk CaP patients managed with radiation therapy (RT) with vs. without hormone therapy (HT)., Methods: Patients with intermediate- and high-risk CaP enrolled in the Center for Prostate Disease Research diagnosed from 2007 to 2017 were included. EPIC and SF-36 questionnaires were completed and HRQoL scores were compared for patients receiving RT vs. RT + HT at baseline (pretreatment), 6, 12, 24, 36, 48, and 60 months after CaP diagnosis. Longitudinal patterns of change in HRQoL were modeled using linear regression models, adjusting for baseline HRQoL, age at CaP diagnosis, race, comorbidities, National Comprehensive Cancer Network (NCCN) risk stratum, time to treatment, and follow-up time., Results: Of 164 patients, 93 (56.7%) received RT alone and 71 (43.3%) received RT + HT. Both groups reported comparable baseline HRQoL. Patients receiving RT+HT were more likely to be NCCN high risk as compared to those receiving only RT. The RT + HT patients experienced worse sexual function, hormonal function, and hormonal bother than those who only received RT; however, HRQoL recovered over time for the RT + HT group. No significant differences were observed between groups in urinary and bowel domains or SF-36 mental and physical scores., Conclusion: Combined RT + HT treatment was associated with temporary lower scores in sexual and hormonal HRQoL compared with RT only. Intermediate- and high-risk CaP patients should be counseled about the possible declines in HRQoL associated with HT., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Introduction: Individual critical task lists (ICTLs) are skills identified by the U.S. Army for the maintenance of combat readiness in each military occupational specialty, including physicians. These lists vary by medical and surgical specialties and are being utilized by leaders to determine individual deployment capability. The lists for urologists include broader tasks that are not routinely performed in a urology practice. Our goal was to create a simulation curriculum to train urologists and to perform validation testing., Materials and Methods: Urology staff and residents at a single military treatment facility underwent a simulation event of urology ICTLs: chest tube, needle decompression, intubation, cricothyroidotomy, and extended focused assessment with sonography for trauma. The simulation was broken down into a pretest, cognitive acquisition, in-person training with subject matter experts for skills acquisition, and a posttest. Content validity questionnaires were administered to participants after the training session. Cognitive acquisition consisted of a series of videos demonstrating task execution and in-person demonstration of tasks and clinical scenarios of when they would be needed. In-person simulation was performed on training mannequins and a sonography simulation trainer., Results: There were a total of nine participants: three residents and six staff urologists, ranging from postgraduate year 2 to more than 10 years out of residency. The total simulation time was 120 min, including 30 min for pretest and viewing of videos. Knowledge-based questions improved from pretest to posttest significantly (mean of 1.2 to 0.1, P < .001). Confidence performing tasks improved significantly on all tasks (P ≤ .01). All participants felt the simulation to be beneficial and had more comfort with the tasks., Conclusions: The novel urology ICTL curriculum using simulation is a feasible and well-received way to keep competency on these tasks and maintain readiness. Face and content validity was established for the urology ICTL simulation curriculum, and the curriculum is exportable to equip urologists at other facilities for the urology ICTLs and for deployments, where life-saving interventions may be necessary from urologists that may be outside their ordinary scope of practice., (Published by Oxford University Press on behalf of the Association of Military Surgeons of the United States 2020. This work is written by (a) US Government employee(s) and is in the public domain in the US.)

Objective: To demonstrate the noninferiority of the fundamentals of robotic surgery (FRS) skills curriculum over current training paradigms and identify an ideal training platform., Summary Background Data: There is currently no validated, uniformly accepted curriculum for training in robotic surgery skills., Methods: Single-blinded parallel-group randomized trial at 12 international American College of Surgeons (ACS) Accredited Education Institutes (AEI). Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016. Benchmarks (proficiency levels) on the 7 FRS Dome tasks were established based on expert performance. Participants were then randomly assigned to 4 training groups: Dome (n = 29), dV-Trainer (n = 30), and DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula. The primary outcome was participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test). Secondary outcomes included cognitive test scores, GEARS ratings, and robot familiarity checklist scores., Results: All groups demonstrated significant performance improvement after skills training (P < 0.01). Participating residents and fellows performed tasks faster (DOME and DVSS groups) and with fewer errors than controls (DOME group; P < 0.01). Inter-rater reliability was high for the checklist scores (0.82-0.97) but moderate for GEARS ratings (0.40-0.67)., Conclusions: We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test. We therefore argue for its implementation across training programs before surgeons apply these skills clinically.

Introduction: Urinalysis is the defining test for microscopic hematuria and has traditionally been performed via microscopy. In recent years automated urinalysis machines, which use different technology to identify cells, have been widely adopted. There is little understanding of these machines in the urology community and how their use may affect evaluation of hematuria., Methods: We compared commercially available automated urinalysis machines and reviewed the literature comparing these machines to microscopic urinalysis. We also reviewed local hospital practices regarding these systems., Results: We identified 6 commercially available machines, almost all of which use flow cytometry as the mechanism to identify red blood cells. Review of the literature and local practice revealed differing definitions of normal range for red blood cells, most of which do not correlate with the American Urological Association definition of microscopic hematuria. There are also several methods for calibrating the machines in comparison to traditional microscopy., Conclusions: Use of automated urinalysis machines is widespread. However, these methods do not correspond exactly to traditional microscopy and use varying definitions of microscopic hematuria. These findings warrant additional investigation into the role of these devices in the definition of microscopic hematuria to prevent unneeded evaluations and to appropriately use health care resources.

Introduction: To assess the impact of primary and secondary therapies for high- and intermediate-risk prostate cancer on health-related quality of life (HRQoL)., Materials and Methods: A prospective study was initiated in 2007 at Center for Prostate Disease Research Multicenter National Database sites. Longitudinal patterns in HRQoL from baseline (pre-treatment) to 5 years post-diagnosis were examined for patients with high- and intermediate-risk prostate cancer, treated by radical prostatectomy (RP) or external beam radiation therapy (EBRT). Change in HRQoL was modeled using linear regression models fit with generalized estimating equations. The probability of maintaining HRQoL was compared between patients receiving RP only versus RP with secondary treatment., Results: Of 445 men with high- and intermediate-risk prostate cancer, 228 underwent RP and 143 had EBRT± androgen deprivation therapy (ADT). Fifty received secondary therapy (EBRT and/or ADT or chemotherapy) after RP. RP patients showed a greater decline over time in sexual function and bother and urinary function compared to EBRT±ADT patients. Patients who had secondary therapy after RP were less likely to maintain their HRQoL compared to those who had RP alone. These differences were most pronounced for sexual and hormonal function., Conclusions: Prostate cancer patients experience significant declines in HRQoL after primary therapy. Additional secondary therapy after RP, in the form of EBRT and/or ADT, appears to be responsible for further deterioration in HRQoL outcomes.

Purpose: The aim of this study was to identify the effects of subsequent prostate needle biopsies after the baseline biopsy on health related quality of life with time. We compared men with and without prostate cancer, and men who did and did not undergo followup prostate needle biopsy., Materials and Methods: Included in analysis were patients enrolled in the Center for Prostate Disease Research Multicenter National Database between 2007 and 2015 who had low or favorable intermediate risk prostate cancer, were on active surveillance and underwent prostate needle biopsy for suspicion of prostate cancer. Patients completed the EPIC (Expanded Prostate Cancer Index Composite) and the RAND SF-36 (36-Item Short Form Health Survey) after baseline biopsy and at regular followup intervals. Mean health related quality of life was compared with time between patients who did and did not undergo subsequent prostate needle biopsies following baseline., Results: Of the 637 patients included in study 129 (20.3%) with prostate cancer were on active surveillance and 508 (79.7%) were in the noncancer group. In the cancer and noncancer groups mean ± SD followup was 34.7 ± 16.9 and 31.6 ± 14.6 months, respectively. Of the patients with prostate cancer 54 (60.7%) underwent subsequent prostate needle biopsies compared with 114 (27.1%) without cancer. No significant impact on health related quality of life was observed in men who underwent subsequent prostate needle biopsies during a 5-year period., Conclusions: A subsequent prostate needle biopsy is required in most active surveillance protocols and in men with persistent suspicion of prostate cancer. Our analysis shows that subsequent prostate needle biopsies do not significantly impact health related quality of life.

Objectives: To discuss an unusual presentation of solitary fibrous tumor (SFT) as well as the first description of SFT originating from the renal vein., Case Report: In this article, we report the case of a 56-year-old man who presented with nonspecific epigastric pain and was found on computed tomography to have a large 10-cm renal artery aneurysm with evidence of contained rupture, segmental ischemia of the kidney, and suggestion of renal vein thrombosis. This was treated by a multidisciplinary team of urologists, vascular surgeons, and interventional radiologists with both renal artery coil embolization and radical nephrectomy. The thrombosis was found on pathologic review to be a malignant SFT originating from the renal vein with likely erosion into the renal artery., Conclusion: This report describes the first case of SFT originating from the renal vein and demonstrates the potential for mimicry as a giant renal artery aneurysm.

Background and Objectives: The uses of robotics in surgery were hypothesized as far back as 1967, but it took nearly 30 years and the nation's largest agency, the Department of Defense, in conjunction with innovative startups and established research agencies to complete the first fully functional multipurpose surgical robot. Currently, the most prominently available multipurpose robotic surgery system with US Food and Drug Administration approval is Intuitive Surgical Inc.'s da Vinci Surgical System, which is found in operating rooms across the globe. Although now ubiquitous for minimally invasive surgery, early surgical robot prototypes were specialty focused. Originally, multipurpose robotic systems were intended for long-distance trauma surgery in battlefield settings. While there were impressive feats of telesurgery, the marketable focus has veered from this goal. Initially developed through SRI International and Defense Advanced Research Projects Agency, surgical robotics reached private industry through two major competitors, who later merged., Methods: A thorough search of PubMed, Clinical Key, EBSCO, Ovid, ProQuest, and industry manufacturers' websites yielded 62 relevant articles, of which 51 were evaluated in this review., Conclusion: We analyzed the literature and referred to primary sources by conducting interviews with present and historical leaders in the field to yield a detailed chronology of surgical robotics development. As minimally invasive robotic procedures are becoming the standard of care, it is crucial to comprehensively document their historical context and importance as an emerging and evolving discipline., Competing Interests: Conflict of interest: Jacques Marescaux is the president of both IRCAD and IHU Institutes, which are partly funded by Karl Storz, Medtronic, and Siemens Healthcare. Ms George and Drs Brand, LaPorta, and Satava have nothing to disclose. These views are those of the authors and not of the US Department of Defense.

Objective: To compare the length of the membranous (functional) urethra in male patients who underwent the male transobturator sling (TOS) for postradical prostatectomy urinary incontinence (PPI). The TOS is in established use for treatment of PPI; however, the precise mechanism of action is unknown., Materials and Methods: This is a prospective case-controlled study on men undergoing male TOS surgery from 2008 to 2014. The comparison arm included patients without incontinence after radical prostatectomy. All participants underwent dynamic magnetic resonance imaging (MRI) at baseline and this was repeated after TOS placement for those who underwent the procedure. Three standardized points were measured using MRI and compared in both groups in addition to clinical measures., Results: Thirty-nine patients were enrolled and 31 patients completed the protocols. The controls (N = 14) had a longer vesicourethral anastomosis to urethra measured at the penile bulb (functional urethral length) distance compared to the pre-TOS group at rest (1.92 cm controls vs 1.27 cm pre-TOS, P = .0018) and at Valsalva (2.13 cm controls vs 1.72 cm pre-TOS, P = .0371). Placement of the sling (N = 17) increased the functional urethral length distance at rest (1.92 cm control vs 1.53 cm post-TOS, P = .09) and at Valsalva (1.94 cm post-TOS vs 2.13 cm control, P = .61), so that the difference was no longer statistically significant., Conclusion: We identified that one possible mechanism in improvement in stress urinary incontinence post-TOS placement is the lengthening of the vesicourethral anastomosis to bulbar-urethra distance. This is the first such study utilizing dynamics MRI in post prostatectomy controls, incontinent pre-TOS, and post-TOS to assess and show these findings., (Copyright © 2018 Elsevier Inc. All rights reserved.)

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

Background and Objectives: There are several different commercially available virtual-reality robotic simulators, but very little comparative data. We compared the face and content validity of 3 robotic surgery simulators and their pricing and availability., Methods: Fifteen participants completed one task on each of the following: dV-Trainer (dVT; Mimic Technologies, Inc., Seattle, Washington, USA), da Vinci Skills Simulator (dVSS; Intuitive Surgical Inc., Sunnyvale, California, USA), and RobotiX Mentor (RM; 3D Systems, Rock Hill, South Carolina, USA). Participants completed previously validated face and content validity questionnaires and a demographics questionnaire. Statistical analysis was then performed on the scores., Results: Participants had a mean age of 29.6 (range, 25-41) years. Most were surgical trainees, having performed a mean of 8.6 robotic primary surgeries. For face validity, ANOVA showed a significant difference favoring the dVSS over the dVT ( P = .001), and no significant difference between the RM, dVSS, and dVT. Content validity revealed similar results, with a significant difference between the dVSS and dVT ( P = .021), a trend toward a difference between the RM and dVT ( P = .092), and no difference between the dVSS and RM ( P = .99)., Conclusion: All simulators demonstrated evidence of face and content validity, with significantly higher scores for the dVSS; it is also the least costly ($80,000 for the simulator), although it is frequently unavailable because of intra-operative use. The dVT and RM have similar face and content validity, are slightly more expensive, and are readily available.

Objective: To evaluate in more detail the effectiveness of a new designed more efficient ultrasonic propulsion for large stones and specific stone compositions in a tissue phantom model. In the first clinical trial of noninvasive ultrasonic propulsion, urinary stones of unknown compositions and sizes up to 10 mm were successfully repositioned., Materials and Methods: The study included 8- to 12-mm stones of 4 different primary compositions (calcium oxalate monohydrate, ammonium acid urate, calcium phosphate, and struvite) and a renal calyx phantom consisting of a 12 mm × 30 mm well in a 10-cm block of tissue-mimicking material. Primary outcome was the number of times a stone was expelled over 10 attempts, with ultrasonic propulsion burst duration varying from 0.5 seconds to 5 seconds., Results: Overall success rate at expelling stones was 95%. All calcium oxalate monohydrate and ammonium acid urate stones were expelled 100% of the time. The largest stone (12 mm) became lodged within the 12-mm phantom calyx 25% of the time regardless of the burst duration. With the 0.5-second burst, there was insufficient energy to expel the heaviest stone (0.88 g), but there was sufficient energy at the longer burst durations., Conclusion: With a single burst, ultrasonic propulsion successfully moved most stones at least 3 cm and, regardless of size or composition, expelled them from the calyx. Ultrasonic propulsion is limited to the stones smaller than the calyceal space, and for each burst duration, related to maximum stone mass., (Published by Elsevier Inc.)

Purpose: In the first-in-human trial of ultrasonic propulsion, subjects passed collections of residual stone fragments repositioned with a C5-2 probe. Here, effectiveness and safety in moving multiple fragments are compared between the C5-2 and a custom (SC-50) probe that produces a longer focal beam and burst duration., Materials and Methods: Effectiveness was quantified by the number of stones expelled from a calyx phantom consisting of a 30-mm deep, water-filled well in a block of tissue mimicking material. Each probe was positioned below the phantom to move stones against gravity. Single propulsion bursts of 50 ms or 3 s duration were applied to three separate targets: 10 fragments of 2 different sizes (1-2 and 2-3 mm) and a single 4 × 7 mm human stone. Safety studies consisted of porcine kidneys exposed to an extreme dose of 10-minute burst duration, including a 7-day survival study and acute studies with surgically implanted stones., Results: Although successful in the clinical trial, the shorter focal beam and maximum 50 ms burst duration of the C5-2 probe moved stones, but did not expel any stones from the phantom's 30-mm deep calyx. The results were similar with the SC-50 probe under the same 50 ms burst duration. Longer (3 s) bursts available with the SC-50 probe expelled all stones at both 4.5 and 9.5 cm "skin-to-stone" depths with lower probe heating compared to the C5-2. No abnormal behavior, urine chemistry, serum chemistry, or histological findings were observed within the kidney or surrounding tissues for the 10 min burst duration used in the animal studies., Conclusions: A longer focal beam and burst duration improved expulsion of a stone and multiple stone fragments from a phantom over a broad range of clinically relevant penetration depths and did not cause kidney injury in animal studies.

Introduction: Patients with low-risk prostate cancer (PCa) often have excellent oncologic outcomes. However, treatment with curative intent can lead to decrements in health-related quality of life (HRQoL). Patients treated with radical prostatectomy have been shown to suffer declines in urinary and sexual HRQoL as compared to those managed with active surveillance (AS). Similarly, patients treated with external-beam radiation therapy (EBRT) are hypothesized to experience greater declines in bowel HRQoL. As health-related quality-of-life (HRQoL) concerns are paramount when selecting among treatment options for low-risk PCa, this study examined HRQoL outcomes in men undergoing EBRT as compared to AS in a prospective, racially diverse cohort., Methods: A prospective study of HRQoL in patients with PCa enrolled in the Center for Prostate Disease Research (CPDR) Multicenter National Database was initiated in 2007. The current study included patients diagnosed through April 2014. HRQoL was assessed with the Expanded Prostate Cancer Index Composite (EPIC) and the Medical Outcomes Study Short Form (SF-36). Temporal changes in HRQoL were compared for patients with low-risk PCa managed on AS vs. EBRT at baseline, 1-, 2-, and 3 years post-PCa diagnosis. Longitudinal patterns were modeled using linear regression models fitted with generalized estimating equations (GEE), adjusting for baseline HRQoL, demographic, and clinical patient characteristics., Results: Of the 499 eligible patients with low-risk PCa, 103 (21%) selected AS and 60 (12%) were treated with EBRT. Demographic characteristics of the treatment groups were similar, though a greater proportion of patients in the EBRT group were African American (P = 0.0003). At baseline, both treatment groups reported comparable HRQoL. EBRT patients experienced significantly worse bowel function and bother at 1 year (adjusted mean score: 87 vs. 95, P = 0.001 and 89 vs. 95, P = 0.008, respectively) and 2 years (87 vs. 93, P = 0.007 and 87 vs. 96, P = 0.002, respectively) compared to patients managed on AS. In contrast to those on AS, more than half the number of patients who received EBRT experienced a decline in bowel function (52% vs. 17%, p=0.003) and bother (52% vs. 15%, P = 0.002) from baseline to 1 year. Patients who received EBRT were significantly more likely to experience a decrease in more than one functional domain (urinary, sexual, bowel, or hormonal) at 1 year when compared with those on AS (60% vs. 28%, P = 0.004)., Conclusions: Patients receiving EBRT for low-risk prostate cancer suffer declines in bowel HRQoL. These declines are not experienced by patients on AS, suggesting that management of low-risk prostate cancer with AS may offer a means for preserving HRQoL following prostate cancer diagnosis., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: The practice patterns for adjuvant therapies for stage I seminoma are rapidly evolving, and surveillance is currently preferred. How these recommendations have affected contemporary practice in an equal-access US population is unknown., Materials and Methods: A total of 436 men diagnosed with clinical stage IA-IB seminoma from 2001 to 2011 were identified in the Automated Central Tumor Registry (ACTUR). The ACTUR is the cancer registry system for the Department of Defense. Logistic regression models analyzed the association between patient characteristics and adjuvant therapy. Overall and recurrence-free survival were determined from Kaplan-Meier analysis., Results: The use of adjuvant radiotherapy in this population decreased significantly from 2001 to 2011. In 2001, 83.9% of patients received radiotherapy compared with only 24.0% in 2011. During that period, a concomitant increase occurred in the use of chemotherapy from 0% to 38.0%. A later year of diagnosis was significantly associated with a greater rate of receiving chemotherapy relative to radiotherapy (P < .001 for 2006-2011 vs. 2001-2005; relative rate ratio, 19.3; 95% confidence interval [CI], 8.04-46.13). A later year of diagnosis was not significantly associated with the receipt of surveillance (P = .412 for 2006-2011 vs. 2001-2005; odds ratio, 0.83; 95% CI, 0.54-1.29). Black race or age was not significantly associated with adjuvant therapy. With a median follow-up period of 4.7 years, the 5-year overall and recurrence-free survival rates were 98.0% and 77.0%, respectively., Conclusion: The use of adjuvant radiotherapy has been replaced by chemotherapy for clinical stage I testicular seminoma in an equal-access system. The lack of an increase in active surveillance in our cohort might represent overtreatment of the population., (Published by Elsevier Inc.)

Purpose: Active surveillance is an important alternative to definitive therapy for men with low risk prostate cancer. However, the impact of active surveillance on health related quality of life compared to that in men without cancer remains unknown. In this study we evaluated health related quality of life outcomes in men on active surveillance compared to men followed after negative prostate needle biopsy., Materials and Methods: A prospective study was conducted on men who were enrolled into the Center for Prostate Disease Research Multicenter National Database and underwent prostate needle biopsy for suspicion of prostate cancer between 2007 and 2014. Health related quality of life was assessed at biopsy (baseline) and annually for up to 3 years using SF-36 and EPIC questionnaires. Health related quality of life scores were modeled using generalized estimating equations, adjusting for baseline health related quality of life, and demographic and clinical characteristics., Results: Of the 1,204 men who met the initial eligibility criteria 420 had a negative prostate needle biopsy (noncancer comparison group). Among the 411 men diagnosed with low risk prostate cancer 89 were on active surveillance. Longitudinal analysis revealed that for most health related quality of life subscales there were no significant differences between the groups in adjusted health related quality of life score trends over time., Conclusions: In this study most health related quality of life outcomes in patients with low risk prostate cancer on active surveillance did not differ significantly from those of men without prostate cancer. A comparison group of men with a similar risk of prostate cancer detection is critical to clarify the psychological and physical impact of active surveillance., (Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Objective: To perform patient-specific meta-analysis (MA) of two independent clinical validation studies of a 17-gene biopsy-based genomic assay as a predictor of favorable pathology at radical prostatectomy., Materials and Methods: Patient-specific MA was performed on data from 2 studies (732 patients) using the Genomic Prostate Score (GPS; scale 0-100) together with Cancer of the Prostate Risk Assessment (CAPRA) score or National Comprehensive Cancer Network (NCCN) risk group as predictors of the likelihood of favorable pathology (LFP). Risk profile curves associating GPS with LFP by CAPRA score and NCCN risk group were generated. Decision curves and receiver operating characteristic curves were calculated using patient-specific MA risk estimates., Results: Patient-specific MA-generated risk profiles ensure more precise estimates of LFP with narrower confidence intervals than either study alone. GPS added significant predictive value to each clinical classifier. A model utilizing GPS and CAPRA provided the most risk discrimination. In decision-curve analysis, greater net benefit was shown when combining GPS with each clinical classifier compared with the classifier alone. The area under the receiver operating characteristic curve improved from 0.68 to 0.73 by adding GPS to CAPRA, and 0.64 to 0.70 by adding GPS to NCCN risk group. The proportion of patients with LFP >80% increased from 11% using NCCN risk group alone to 23% using GPS with NCCN. Using GPS with CAPRA identified the highest proportion-31%-of patients with LFP >80%., Conclusion: Patient-specific MA provides more precise risk estimates that reflect the complete body of evidence. GPS adds predictive value to 3 widely used clinical classifiers, and identifies a larger proportion of low-risk patients than identified by clinical risk group alone., (Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Objective quantification of surgical skill is imperative as we enter a healthcare environment of quality improvement and performance-based reimbursement. The gold standard tools are infrequently used due to time-intensiveness, cost inefficiency, and lack of standard practices. We hypothesized that valid performance scores of surgical skill can be obtained through crowdsourcing., Methods: Twelve surgeons of varying robotic surgical experience performed live porcine robot-assisted urinary bladder closures. Blinded video-recorded performances were scored by expert surgeon graders and by Amazon's Mechanical Turk crowdsourcing crowd workers using the Global Evaluative Assessment of Robotic Skills tool assessing five technical skills domains. Seven expert graders and 50 unique Mechanical Turkers (each paid $0.75/survey) evaluated each video. Global assessment scores were analyzed for correlation and agreement., Results: Six hundred Mechanical Turkers completed the surveys in less than 5 hours, while seven surgeon graders took 14 days. The duration of video clips ranged from 2 to 11 minutes. The correlation coefficient between the Turkers' and expert graders' scores was 0.95 and Cronbach's Alpha was 0.93. Inter-rater reliability among the surgeon graders was 0.89., Conclusion: Crowdsourcing surgical skills assessment yielded rapid inexpensive agreement with global performance scores given by expert surgeon graders. The crowdsourcing method may provide surgical educators and medical institutions with a boundless number of procedural skills assessors to efficiently quantify technical skills for use in trainee advancement and hospital quality improvement.

Background: For patients with low-risk prostate cancer (PCa), active surveillance (AS) may produce oncologic outcomes comparable to those achieved with radical prostatectomy (RP). Health-related quality-of-life (HRQoL) outcomes are important to consider, yet few studies have examined HRQoL among patients with PCa who were managed with AS. In this study, the authors compared longitudinal HRQoL in a prospective, racially diverse, and contemporary cohort of patients who underwent RP or AS for low-risk PCa., Methods: Beginning in 2007, HRQoL data from validated questionnaires (the Expanded Prostate Cancer Index Composite and the 36-item RAND Medical Outcomes Study short-form survey) were collected by the Center for Prostate Disease Research in a multicenter national database. Patients aged ≤75 years who were diagnosed with low-risk PCa and elected RP or AS for initial disease management were followed for 3 years. Mean scores were estimated using generalized estimating equations adjusting for baseline HRQoL, demographic characteristics, and clinical patient characteristics., Results: Of the patients with low-risk PCa, 228 underwent RP, and 77 underwent AS. Multivariable analysis revealed that patients in the RP group had significantly worse sexual function, sexual bother, and urinary function at all time points compared with patients in the AS group. Differences in mental health between groups were below the threshold for clinical significance at 1 year., Conclusions: In this study, no differences in mental health outcomes were observed, but urinary and sexual HRQoL were worse for patients who underwent RP compared with those who underwent AS for up to 3 years. These data offer support for the management of low-risk PCa with AS as a means for postponing the morbidity associated with RP without concomitant declines in mental health., (© 2015 American Cancer Society.)

Background: Biomarkers that are validated in independent cohorts are needed to improve risk assessment for prostate cancer (PCa)., Objective: A racially diverse cohort of men (20% African American [AA]) was used to evaluate the association of the clinically validated 17-gene Genomic Prostate Score (GPS) with recurrence after radical prostatectomy and adverse pathology (AP) at surgery., Design, Setting, and Participants: Biopsies from 431 men treated for National Comprehensive Cancer Network (NCCN) very low-, low-, or intermediate-risk PCa between 1990 and 2011 at two US military medical centers were tested to validate the association between GPS and biochemical recurrence (BCR) and to confirm the association with AP. Metastatic recurrence (MR) was also evaluated., Outcome Measurements and Statistical Analysis: Cox proportional hazards models were used for BCR and MR, and logistic regression was used for AP. Central pathology review was performed by one uropathologist. AP was defined as primary Gleason pattern 4 or any pattern 5 and/or pT3 disease., Results and Limitations: GPS results (scale: 0-100) were obtained in 402 cases (93%); 62 men (15%) experienced BCR, 5 developed metastases, and 163 had AP. Median follow-up was 5.2 yr. GPS predicted time to BCR in univariable analysis (hazard ratio per 20 GPS units [HR/20 units]: 2.9; p<0.001) and after adjusting for NCCN risk group (HR/20 units: 2.7; p<0.001). GPS also predicted time to metastases (HR/20 units: 3.8; p=0.032), although the event rate was low (n=5). GPS was strongly associated with AP (odds ratio per 20 GPS units: 3.3; p<0.001), adjusted for NCCN risk group. In AA and Caucasian men, the median GPS was 30.3 for both, the distributions of GPS results were similar, and GPS was similarly predictive of outcome., Conclusions: The association of GPS with near- and long-term clinical end points establishes the assay as a strong independent measure of PCa aggressiveness. Tumor aggressiveness, as measured by GPS, and outcomes were similar in AA and Caucasian men in this equal-access health care system., Patient Summary: Predicting outcomes in men with newly diagnosed prostate cancer is challenging. This study demonstrates that a new molecular test, the Genomic Prostate Score, which can be performed on a patient's original prostate needle biopsy, can predict the aggressiveness of the cancer and help men make decisions regarding the need for immediate treatment of their cancer., (Copyright © 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Renal ischemia-reperfusion (IR) causes acute kidney injury (AKI) with high mortality and morbidity. The objective of this investigation was to ameliorate kidney IR injury and identify novel biomarkers for kidney injury and repair. Under general anesthesia, left renal ischemia was induced in Wister rats by occluding renal artery for 45 minutes, followed by reperfusion and right nephrectomy. Thirty minutes prior to ischemia, rats (n = 8/group) received Valproic Acid (150 mg/kg; VPA), Dexamethasone (3 mg/kg; Dex) or Vehicle (saline) intraperitoneally. Animals were sacrificed at 3, 24 or 120 h post-IR. Plasma creatinine (mg/dL) at 24 h was reduced (P<0.05) in VPA (2.7±1.8) and Dex (2.3±1.2) compared to Vehicle (3.8±0.5) group. At 3 h, urine albumin (mg/mL) was higher in Vehicle (1.47±0.10), VPA (0.84±0.62) and Dex (1.04±0.73) compared to naïve (uninjured/untreated control) (0.14±0.26) group. At 24 h post-IR urine lipocalin-2 (μg/mL) was higher (P<0.05) in VPA, Dex and Vehicle groups (9.61-11.36) compared to naïve group (0.67±0.29); also, kidney injury molecule-1 (KIM-1; ng/mL) was higher (P<0.05) in VPA, Dex and Vehicle groups (13.7-18.7) compared to naïve group (1.7±1.9). Histopathology demonstrated reduced (P<0.05) ischemic injury in the renal cortex in VPA (Grade 1.6±1.5) compared to Vehicle (Grade 2.9±1.1). Inflammatory cytokines IL1β and IL6 were downregulated and anti-apoptotic molecule BCL2 was upregulated in VPA group. Furthermore, kidney DNA microarray demonstrated reduced injury, stress, and apoptosis related gene expression in the VPA administered rats. VPA appears to ameliorate kidney IR injury via reduced inflammatory cytokine, apoptosis/stress related gene expression, and improved regeneration. KIM-1, lipocalin-2 and albumin appear to be promising early urine biomarkers for the diagnosis of AKI.

Background: Crowdsourcing is the practice of obtaining services from a large group of people, typically an online community. Validated methods of evaluating surgical video are time-intensive, expensive, and involve participation of multiple expert surgeons. We sought to obtain valid performance scores of urologic trainees and faculty on a dry-laboratory robotic surgery task module by using crowdsourcing through a web-based grading tool called Crowd Sourced Assessment of Technical Skill (CSATS)., Methods: IRB approval was granted to test the technical skills grading accuracy of Amazon.com Mechanical Turk™ crowd-workers compared to three expert faculty surgeon graders. The two groups assessed dry-laboratory robotic surgical suturing performances of three urology residents (PGY-2, -4, -5) and two faculty using three performance domains from the validated Global Evaluative Assessment of Robotic Skills assessment tool., Results: After an average of 2 hours 50 minutes, each of the five videos received 50 crowd-worker assessments. The inter-rater reliability (IRR) between the surgeons and crowd was 0.91 using Cronbach's alpha statistic (confidence intervals=0.20-0.92), indicating an agreement level between the two groups of "excellent." The crowds were able to discriminate the surgical level, and both the crowds and the expert faculty surgeon graders scored one senior trainee's performance above a faculty's performance., Conclusion: Surgery-naive crowd-workers can rapidly assess varying levels of surgical skill accurately relative to a panel of faculty raters. The crowds provided rapid feedback and were inexpensive. CSATS may be a valuable adjunct to surgical simulation training as requirements for more granular and iterative performance tracking of trainees become mandated and commonplace.

Background: Preoperative simulation warm-up has been shown to improve performance and reduce errors in novice and experienced surgeons, yet existing studies have only investigated conventional laparoscopy. We hypothesized that a brief virtual reality (VR) robotic warm-up would enhance robotic task performance and reduce errors., Study Design: In a 2-center randomized trial, 51 residents and experienced minimally invasive surgery faculty in General Surgery, Urology, and Gynecology underwent a validated robotic surgery proficiency curriculum on a VR robotic simulator and on the da Vinci surgical robot (Intuitive Surgical Inc). Once they successfully achieved performance benchmarks, surgeons were randomized to either receive a 3- to 5-minute VR simulator warm-up or read a leisure book for 10 minutes before performing similar and dissimilar (intracorporeal suturing) robotic surgery tasks. The primary outcomes compared were task time, tool path length, economy of motion, technical, and cognitive errors., Results: Task time (-29.29 seconds, p = 0.001; 95% CI, -47.03 to -11.56), path length (-79.87 mm; p = 0.014; 95% CI, -144.48 to -15.25), and cognitive errors were reduced in the warm-up group compared with the control group for similar tasks. Global technical errors in intracorporeal suturing (0.32; p = 0.020; 95% CI, 0.06-0.59) were reduced after the dissimilar VR task. When surgeons were stratified by earlier robotic and laparoscopic clinical experience, the more experienced surgeons (n = 17) demonstrated significant improvements from warm-up in task time (-53.5 seconds; p = 0.001; 95% CI, -83.9 to -23.0) and economy of motion (0.63 mm/s; p = 0.007; 95% CI, 0.18-1.09), and improvement in these metrics was not statistically significantly appreciated in the less-experienced cohort (n = 34)., Conclusions: We observed significant performance improvement and error reduction rates among surgeons of varying experience after VR warm-up for basic robotic surgery tasks. In addition, the VR warm-up reduced errors on a more complex task (robotic suturing), suggesting the generalizability of the warm-up., (Copyright © 2013 American College of Surgeons. All rights reserved.)

Purpose: Rapid adoption of robot-assisted surgery has outpaced our ability to train novice roboticists. Objective metrics are required to adequately assess robotic surgical skills and yet surrogates for proficiency, such as economy of motion and tool path metrics, are not readily accessible directly from the da Vinci® robot system. The trakSTAR™ Tool Tip Tracker is a widely available, cost-effective electromagnetic position sensing mechanism by which objective proficiency metrics can be quantified. We validated a robotic surgery curriculum using the trakSTAR device to objectively capture robotic task proficiency metrics., Materials and Methods: Through an institutional review board approved study 10 subjects were recruited from 2 surgical experience groups (novice and experienced). All subjects completed 3 technical skills modules, including block transfer, intracorporeal suturing/knot tying (fundamentals of laparoscopic surgery) and ring tower transfer, using the da Vinci robot with the trakSTAR device affixed to the robotic instruments. Recorded objective metrics included task time and path length, which were used to calculate economy of motion. Student t test statistics were performed using STATA®., Results: The novice and experienced groups consisted of 5 subjects each. The experienced group outperformed the novice group in all 3 tasks. Experienced surgeons described the simulator platform as useful for training and agreed with incorporating it into a residency curriculum., Conclusions: Robotic surgery curricula can be validated by an off-the-shelf instrument tracking system. This platform allows surgical educators to objectively assess trainees and may provide credentialing offices with a means of objectively assessing any surgical staff member seeking robotic surgery privileges at an institution., (Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Objective: To identify genomic markers that are reliable in predicting lymph node metastases in clinical stage 1 non-seminomatous germ cell tumors (NSGCTs)., Methods: Comparative genomic array technology was used to identify regions of genomic amplification or deletion in clinical stage 1 NSGCTs. Twelve stage 1 mixed germ cell testicular tumors were analyzed, which were obtained from 8 patients who had no evidence of nodal metastasis when retroperitoneal lymph node dissection (RPLND) had been performed (ie, were RPLND negative) and 4 patients who had nodal metastases (ie, were RPLND positive)., Results: Differences between the genomic alterations associated with the two classes of tumors were identified. Genomic alterations previously reported in other subtypes of testicular tumors were observed in both metastatic and nonmetastatic cases. Statistically suggestive differences in mean copy number of the Y chromosome were found between metastatic and nonmetastatic cases (P = .0142)., Conclusion: This finding suggests the presence of chromosome Y deletions to be a potential genetic marker for prediction of mixed germ cell tumor progression. This is a first step toward identifying chromosomal markers of progression in testicular cancer in clinical stage 1 mixed germ cell NSGCT., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Virtual reality robotic simulation has gained widespread momentum. In order to determine the value of virtual reality robotic simulation and its objective metrics, a reality-based robotic surgical training platform with similar analytic capabilities must be developed and validated. The ProMIS laparoscopic surgical simulator is a widely available reality-based simulation platform that has been previously validated as an objective measure of laparoscopic task performance. In this study, we evaluated the validity of the ProMIS laparoscopic surgical simulator as an objective measure of robotic task performance. Volunteers were recruited from two experience groups (novice and expert). All subjects completed three tasks (peg transfer, precision cutting, intracorporeal suture/knot) in the ProMIS laparoscopic simulator using the da Vinci robotic surgical system. Motion analysis data was obtained by the ProMIS computerized optical tracking system and objective metrics recorded included time, path length, economy of motion, and observer-recorded penalty scores. The novice group consisted of 10 subjects with no previous robotic surgical experience. The expert group consisted of 10 subjects with robotic experience. The expert group outperformed the novice group in all three tasks. Subjects rated this training platform as easy to use, as an accurate measure of their robotic surgical proficiency, and as relevant to robotic surgery. The experts described the simulator platform as useful for training and agreed with incorporating it into a residency curriculum. This study demonstrates that the ProMIS laparoscopic simulator is a face, content, and construct valid reality-based simulation platform that can be used for objectively measuring robotic task performance.

Purpose: SEMA3B and SEMA3F are 2 closely related genes lying 80 kb apart on chromosome 3 that have been shown to suppress tumor formation in vivo and in vitro. Each gene has a single nucleotide polymorphism that results in a nonsynonymous coding change, rs2071203 (SEMA3B) and rs1046956 (SEMA3F), as well as noncoding single nucleotide polymorphisms., Materials and Methods: We performed a case-control study of 789 prostate cancer cases and 907 controls from 3 races/ethnicities to determine possible associations of 10 variants with prostate cancer risk or prognosis., Results: The risk of prostate cancer increased more than 2-fold in Hispanic men with TT alleles at rs2071203 in SEMA3B and with CC alleles for rs2072054 at the 5' end of SEMA3F (OR 2.13, 95% CI 1.12-4.04, p = 0.02 and OR 2.55, 95% CI 1.34-4.84, p = 0.0045, respectively). These 2 single nucleotide polymorphisms were also associated with a poor prognosis in Hispanic men (2.71 and 3.48-fold increased risk). A frequent G-C-G-G-A-T-C-C-T-G haplotype encompassing 10 SNPs was associated with an increased risk of prostate cancer and poor prognosis in Hispanic samples (OR 2.72, 95% CI 1.20-6.12, p = 0.016 and OR 3.32, 95% CI 1.21-9.10, p = 0.02). In nonHispanic white men the T-C-G-A-A-T-C-C haplotype was associated with a high Gleason score (OR 1.44, 95% CI 1.06-1.96, p = 0.021)., Conclusions: These data indicate that polymorphisms in SEMA3B and SEMA3F are associated with prostate cancer risk and poor prognosis in Hispanic and nonHispanic white men.

Purpose: Because of the role of TGFB1 in prostate cancer and progression, we hypothesized that polymorphisms of TGFB1 at C-509T may be associated with prostate cancer risk and/or more aggressive tumors., Materials and Methods: This is a case-control study. Controls consisted of male volunteers 40 years old or older with a normal digital rectal examination and prostate specific antigen 2.5 ng/ml or less. Cases consisted of men with biopsy proven prostate cancer. High grade prostate cancer included all cancers of Gleason sum 7 or greater. Poor prognosis in cases was defined as any stage with Gleason sum 8-10, pT3A (if Gleason sum was greater than 7), pT3B or higher (all Gleason sums), any N1 or higher, any M1 or higher, or any documented PSA recurrence (biochemical failure). Single nucleotide polymorphisms were genotyped using allelic discrimination assays. Logistic regression models were used to estimate the OR with the corresponding 95% CI for individual racial/ethnic groups. Allelic frequency across ethnic/racial groups was compared using Pearson's chi-square test., Results: A total of 653 cases and 1,476 controls were genotyped at C-509T. The TT genotype showed a significant protective effect against high grade prostate cancer (OR 0.482, 95% CI 0.274-0.849). In addition, the TT genotype was associated with a decreased risk of poor prognosis prostate cancer (OR 0.488, 95% CI 0.236-1.009). Limiting analysis to nonHispanic white men showed that the TT genotype had an even more pronounced protective effect for poor prognosis prostate cancer (OR 0.297, 95% CI 0.100-0.887). Finally, there was a significant difference in the distribution of allelic frequency across racial/ethnic groups (p <0.0001)., Conclusions: We observed an association between single nucleotide polymorphisms of TGFB1 at C-509T and a decreased risk of aggressive prostate cancer. The TT genotype of TGFB1 at C-509T demonstrates a protective effect against high grade prostate cancer and cases with poor prognosis.

Objectives: To test the accuracy of the 2001 Partin Tables in African American men who underwent radical prostatectomy at multiple centers throughout the United States., Methods: We compiled a large multiethnic cohort of men (n = 3748) treated with radical prostatectomy at multiple sites, including all of the sites of the Department of Veterans Affairs-based Shared Equal Access Regional Cancer Hospital (SEARCH) database (n = 1524), Wayne State University (n = 1305), the University of Texas Health Science Center (n = 522), and the Henry Ford Hospital (n = 397). We evaluated the accuracy of the 2001 Partin Tables using area under the receiver operator characteristic curve (AUC) separately among African American and white men., Results: African American men (n = 1188, 32%), despite being more likely to have clinical Stage T1c disease (56% versus 47%, chi-square P <0.001), had higher preoperative PSA values (9.1 versus 7.7 ng/mL, rank-sum P <0.001) and were more likely to have higher-grade disease on diagnostic biopsy (chi-square P = 0.005). Despite these differences in baseline clinical characteristics, the 2001 Partin Tables performed equally well in both racial groups. Specifically, there were no differences in the AUC for African American and white men for predicting organ-confined disease (AUC 0.73 versus 0.72; P = 0.56), extraprostatic extension (AUC 0.62 versus 0.62; P = 0.99), or seminal vesicle invasion (AUC 0.77 versus 0.79; P = 0.53)., Conclusions: These data lend further support to the idea that although baseline differences between the races existed that may underlie an overall more aggressive disease among African American men, for the individual patient, race is not valuable for prognostication.

Objectives: Family history has been identified as a risk factor for prostate cancer. We assessed the risk of prostate cancer in men with a positive family history (at least one first-degree or second-degree relative), normal digital rectal examination (DRE) and a serum prostate-specific antigen (PSA) level of 4.0 ng/mL., Methods: A total of 87 volunteers from the San Antonio Center of biomarkers of risk for prostate cancer study enrolled in a prospective study to assess the prevalence of prostate cancer in men with a family history of prostate cancer, normal DRE findings, and a serum PSA level of 4.0 ng/mL or less. All subjects underwent transrectal ultrasound-guided prostate biopsy., Results: Prostate cancer was diagnosed in 22 (25.3%) of the 87 participants. The PSA values were significantly greater statistically in the men with prostate cancer (median 2.1 ng/mL) than in the men without prostate cancer (median 1.2 ng/mL, P = 0.01), and the odds of prostate cancer nearly doubled for a doubling of the PSA level within this interval (odds ratio 1.97, P = 0.02). No statistically significant difference was found in age, race, or number and type of affected relatives in men with and without prostate cancer., Conclusions: The results of our study have demonstrated a high frequency of prostate cancer in men with a positive family history but normal DRE findings and a PSA level of 4.0 ng/mL or less. These prospectively collected data raise an important consideration regarding lowering the PSA cutoff values for offering biopsy in patients with a positive family history and normal DRE findings.

The number of men for whom testosterone is prescribed is rapidly increasing. The aging man normally demonstrates a gradual decline in testosterone. Symptoms of hypogonadism include erectile dysfunction, diminished libido, sarcopenia, increased adiposity, osteopenia and osteoporosis, impaired cognition, and depression. There is a paucity of data regarding both efficacy and safety of testosterone replacement therapy. Testosterone levels have been shown to modulate prostate cancer risk and progression. A prospective evaluation of prostate cancer risk with testosterone replacement therapy has not been conducted. We outline concerns and recommendations for the use of testosterone replacement therapy in the aging man.

Objectives: Provide a critical summary of the latest interpretation of findings from the Prostate Cancer Prevention Trial (PCPT)., Methods: Findings from PCPT and recently published post-hoc analyses are reviewed., Results: PCPT demonstrated that finasteride can reduce the prevalence of prostate cancer, permitted the first large-scale assessment of the performance characteristics of prostate-specific antigen for prostate cancer screening, and identified new-onset erectile dysfunction as an early predictor of cardiovascular events., Conclusions: PCPT has and will continue to yield valuable information regarding future strategies for prostate cancer prevention and detection, benign prostatic hyperplasia, and other matters of public health importance.

Purpose: We reviewed the results of preliminary studies of select novel agents for metastatic prostate cancer and discuss the potential benefit of these agents for earlier stage disease, eg biochemically recurrent prostate cancer with high risk features., Materials and Methods: Available data on select investigational immunotherapies as well as endothelin-A receptor antagonists and survivin inhibitors were obtained and reviewed through PubMed searches, conference proceedings and unpublished proprietary information, when available., Results: A large number of promising agents are in varying stages of development. Phase III results have been reported for the endothelin-A receptor antagonist atrasentan. Several immunotherapies are currently in phase II/III trials, namely the GM-CSF transduced tumor cell vaccine GVAX, the prostatic acid phosphatase loaded dendritic cell vaccine Provenge and the prostate specific antigen expressing poxvirus vaccine PROSTVAC-VF. Another immunotherapy, the prostate specific membrane antigen immunoconjugate MLN2704 (Millennium Pharmaceuticals, Cambridge, Massachusetts), is in phase I/II study. The first clinical inhibitors of survivin are in early phase I studies. Several of these agents, including atrasentan, have shown statistically significant but modest effects in the advanced disease setting in which they have been studied., Conclusions: Clinical trial design with these novel therapies presents particular challenges since most of these agents may induce disease stabilization rather than disease regression. There is a risk of false-negative results and failure to recognize a potentially efficacious agent if these cytostatic agents are studied only in men with advanced, heavily pretreated disease in whom life expectancy is measured in months. We advocate the early referral and enrollment of men with high risk prostate cancer in clinical trials.

A 25-year-old man presented with painful ejaculation, an ejaculate volume of 0.75, and complaints of passing "granules" in the semen. Transrectal ultrasonography showed bilateral seminal vesicle enlargement. The patient underwent transurethral resection of the ejaculatory duct. The entry point of duct was resected using pure cutting current, resulting in the passage of multiple proteinaceous-appearing stones. Approximately 10 months later, the patient reported recurrent painful ejaculation and passage of granules in his semen. At cystoscopy, the ejaculatory duct openings were intubated with a cone-tipped catheter to perform bilateral seminal vesiculograms, which showed numerous mobile filling defects and a Steinstrasse appearance at the ejaculatory ducts. A 7F semirigid ureteroscope entered the lumen without difficulty over a guidewire, and the stones were fragmented with a 270-microm holmium laser fiber. The ejaculatory ducts were balloon dilated to 18F. To our knowledge, this is the first reported case where a ureteroscope was utilized to treat seminal-vesicle stones. The seminal vesiculogram proved to be extremely valuable in the diagnosis.

Malignancy arising from a multicystic dysplastic kidney (MCDK) is rare. Most reports are of Wilms' tumor and clear-cell renal cell carcinoma arising from a previously unrecognized MCDK. To our knowledge, no reports have described collecting duct carcinoma arising from MCDK.

Prostate cancer is a common malignancy with multiple potential opportunities for cancer prevention. As the genetic basis of this malignancy is further understood, prevention strategies will be developed for individual patients based on specific risk factors and pathways of carcinogenesis. The PCPT has conclusively proven that prostate cancer prevention is possible. The results of the SELECT should be available within several years. An enormous challenge for the medical community will be the development of an efficient strategy to evaluate the substantial number of dietary, behavioral, and pharmacologic prevention opportunities. Ultimately, the goal of prostate can-cer prevention is to (1) identify men who are destined to develop clinically significant prostate cancer, and (2) provide individualized agents to prevent disease development.

Most prostate biopsies do not show malignancy. The proper management of non-cancerous pathologic findings of the prostate is controversial. For this article, we reviewed the current literature for indications for repeat prostate biopsy after initial biopsies demonstrated non-cancerous prostatic tissue or benign prostatic hyperplasia. This review includes discussions of management of asymptomatic prostatitis and how it may affect prostate-specific antigen, and also the management of several potentially premalignant lesions such as atrophy, atypical small acinar proliferation, and high-grade prostatic intraepithelial neoplasia. There is a paucity of randomized trials in this area and, considering the high number of biopsies with non-malignant findings, we conclude that more investigation is warranted in this area.

Prostate cancer is a significant cause of disease and death, making it an attractive target for chemoprevention. The association between lifetime exposure to dihydrotestosterone and risk of developing prostate cancer suggests that chemoprevention is possible with 5alpha-reductase inhibition. The recently completed Prostate Cancer Prevention Trial indicates that chemoprevention is possible with the 5alpha-reductase inhibitor finasteride. Development of a cost-effective chemoprevention strategy for prostate cancer is evolving, and is expected to have significant positive economic and public health benefits.

Prostate cancer is the most common malignancy in men and, as a result, there has been a nationwide emphasis on screening and detection. With the widespread use of the prostate-specific antigen (PSA), prostate cancer screening effectively detects localized prostate cancer. However, recent reports have identified a significant proportion of prostate cancer in men with low PSA levels. Many of these cancers are higher-grade malignancies. Consequently, PSA may function more effectively as a screening tool when applied over a continuum that is associated with degree of risk, rather than a binary measure. Other markers are currently being investigated. Ideally, a marker will identify the malignancy that is a clinical threat, thereby avoiding intervention for indolent disease. Prevention strategies may be employed for higher-risk patients, and these strategies eventually may be tailored to genetic or other risks.

Background: An understanding of the patterns of failure after potentially curative treatment of breast cancer patients can lead to the development of improved methods of patient management., Methods: We compared two groups of patients in whom breast cancer recurred after potentially curative treatment. Patients were assigned to their groups based on the status of their lymph nodes at the time of presentation., Results: In all, 294 recurrences were analyzed to demonstrate that the patterns of failure for the two groups were identical. In the node-positive group, recurrence occurred sooner and their primary tumors were larger., Conclusion: The nearly identical patterns of treatment failure in lymph node negative and positive breast cancer patients suggests that metastasis in node negative patients occurs by a similar mechanism. The shorter time to recurrence and larger primary tumor may only reflect a lead time bias, in that node-positive patients have a greater tumor burden in their lymph nodes that facilitates identification by pathologists.