Race-specific prostate cancer outcomes in a cohort of low and favorable-intermediate risk patients who underwent external beam radiation therapy from 1990 to 2017.

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.

Current State of Advanced Practice Providers in Urological Practice.

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.

Urology Individual Critical Task List: Creation and Validation of a Simulation Curriculum.

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.

Proving the Effectiveness of the Fundamentals of Robotic Surgery (FRS) Skills Curriculum: A Single-blinded, Multispecialty, Multi-institutional Randomized Control Trial.

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.

A prospective analysis of health-related quality of life in intermediate and high-risk prostate cancer patients managed with intensity modulated radiation therapy, with vs. without hormonal therapy.

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.

Automated Urinalysis for Evaluation of Microscopic Hematuria: Current Options and Revising the Gold Standard.

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.

A prospective study of health-related quality of life outcomes among men treated for intermediate- and high-risk prostate cancer: the impact of primary and secondary therapies.

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.

Impact of Subsequent Biopsies on Comprehensive Health Related Quality of Life in Patients with and without Prostate Cancer.

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.

Malignant Solitary Fibrous Tumor of the Renal Vein Presenting as a Giant Renal Artery Aneurysm: A Case Report and Review of Literature.

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.

Origins of Robotic Surgery: From Skepticism to Standard of Care.

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.

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

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

Head-to-Head Comparison of Three Virtual-Reality Robotic Surgery Simulators.

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.

Mechanism of Action of the Transobturator Sling for Post-Radical Prostatectomy Incontinence: A Multi-institutional Prospective Study Using Dynamic Magnetic Resonance Imaging.

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.

Effect of Stone Size and Composition on Ultrasonic Propulsion Ex Vivo.

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.

Filariasis Orchitis-Differential for Acute Scrotum Pathology.

Granulomatous Orchitis secondary to lymphatic filiarisis is a rare diagnosis within the United States. We report a case of a 22yo Male from Sri Lanka, with a new onset scrotal swelling and palpable right testicular mass. Ultrasound identified a 1 cm right testicular mass with signs of tunica albuginea invasion. A right inguinal radical orchiectomy was performed and pathology showed Filarial orchitis. This report describes the detailed history, physical exam, and diagnostic workup and treatment options for a rare entity for acute scrotal pathology.

Safety and Effectiveness of a Longer Focal Beam and Burst Duration in Ultrasonic Propulsion for Repositioning Urinary Stones and Fragments.

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.

A prospective study of health-related quality-of-life outcomes for patients with low-risk prostate cancer managed by active surveillance or radiation therapy.

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.