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Retzius-sparing robot-assisted radical prostatectomy (RS-RARP) has been shown to improve continence. However, questions remain regarding feasibility and generalizability of technique and outcomes.To compare the outcomes of 140 consecutive standard robot-assisted radical prostatectomy (S-RARP) versus RS-RARP.A total of 70 S-RARPs were performed followed by 70 RS-RARPs. Demographic, pathologic, and functional outcomes were compared preoperatively and through 12 mo. Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) was used to compare functional outcomes. Logistic and linear regression analyses were utilized to analyze variables associated with EPIC-CP urinary incontinence and overall quality of life (QOL) scores, and oncologic outcomes. Cox regression analysis was used to analyze incontinence at 12 mo.RS-RARP versus S-RARP.Patient and tumor characteristics (age, body mass index, prostate-specific antigen, Charlson Comorbidity Index, Gleason group, clinical stage, and Prostate Imaging Reporting and Data System score), perioperative outcomes (console time, estimated blood loss, postoperative complications, and length of stay), oncologic outcomes (positive surgical margin [PSM], and biochemical recurrence), overall and 12-mo continence rates (zero pads and zero to one safety pad), time to continence, potency (erection sufficient for sexual activity), EPIC-CP urinary incontinence, sexual function, and overall QOL scores.Median follow-up for S-RARP versus RS-RARP was 46.3 versus 12.3 mo. RS-RARP versus S-RARP had improved overall continence rates at total follow-up (95.7% vs 85.7%, p = 0.042) and 12-mo follow-up (97.6% vs 81.4%, p = 0.002), and faster return to continence (zero to one safety pad, 44 vs 131 d, p 0.001). RS-RARP EPIC-CP urinary incontinence and overall QOL scores remained significantly better at 12 mo. There were no differences in overall PSM rates, although RS-RARP had lower rates of nonfocal PSMs. There were no differences in sexual function. In multivariate analysis, RS-RARP was significantly associated with improved 12-mo EPIC-CP urinary incontinence and improved QOL scores, but was not associated with PSM or biochemical recurrence. Limitations include retrospective study design and unequal follow-up; however, significantly better RS-RARP continence at 12 mo is striking despite fewer patients attaining 12-mo follow-up.RS-RARP significantly improves early and long-term continence without compromising oncologic outcomes and leads to overall improved QOL.Retzius-sparing robot-assisted radical prostatectomy is an emerging technique for robotic radical prostatectomy that improves urinary function and quality of life without compromising cancer control.

A minimum number of index procedures is required for graduation. Without thresholds for surgical technique, it is unclear if robotic and open learning is balanced. We assessed the distribution of robotic and open surgeries performed by residents upon graduation.Voluntary Accreditation Council for Graduate Medical Education resident case logs from 11 institutions were de-identified and trends in robotic and open major surgeries were compared using Wilcoxon rank sum and 2-sample t-tests.A total of 89,199 major cases were recorded by 209 graduates from 2011 to 2017. The median proportion of robotic cases increased from 2011 to 2017 in reconstruction (4.7% to 15.2%), oncology (27.5% to 54.2%) and pediatrics (0% to 10.9%) (all values p0.001). Robotic and open cases remained most divergent in reconstruction, with a median of 12 robotic (IQR 9-19) to 70 open cases (IQR 55-106) being performed by residents in 2017. Similar observations occurred in pediatrics. In oncology the number of robotic procedures superseded that of open in 2016 and rose to a median of 148 robotic (IQR 108-214) to 121 open cases (IQR 90-169) in 2017, with the driver being robotic prostatectomy. Substantial differences in surgical technique were observed between institutions and among graduates from the same institution.Although robotic volume is increasing, the balance of surgical technique and the pace of change differ in reconstruction, oncology and pediatrics, as well as among individual institutions and graduates themselves. This raises questions about whether more specific guidelines are needed to ensure equity and standardization in training.

Purpose: Cisplatin-based neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) is standard of care for muscle-invasive bladder cancer (MIBC). However, NAC is used in less than 20% of patients with MIBC. Our goal is to investigate factors that contribute to underutilization NAC to facilitate more routine incorporation into clinical practice. Materials and Methods: We identified 5,915 patients diagnosed with cT2-T3N0M0 MIBC who underwent RC between 2004 and 2014 from the National Cancer Database. Univariate and multivariable models were created to identify variables associated with NAC utilization. Results: Only 18.8% of patients received NAC during the study period. On univariate analyses, NAC utilization was more likely at academic hospitals, US South and Midwest (p

Recent clinical trials have investigated the benefit of combining tyrosine kinase inhibitors (TKIs) and cytoreductive nephrectomy (CN) in patients with metastatic renal cell carcinoma. Our goal is to determine whether the perioperative use of TKIs increases the postoperative morbidity following CN in renal cell carcinoma patients. We identified 627 patients with Stage IV renal cell carcinoma who underwent CN from 2007–2010 utilizing the SEER-Medicare database. Eighty-two patients treated with TKIs were matched (3:1) to 246 controls. We calculated 30- and 90-day incidence rates of postoperative complications and mortality. On unadjusted analysis, TKI use prior to CN was associated with higher overall complication rate within 30 days (HR = 2.73, 95% CI: 1.09–6.8) after surgery. On multivariate analysis, perioperative TKI use was independently associated with higher risk for postoperative complications within 30 days (HR = 2.93, 95% CI: 1.17–7.36), as well as 90 days (HR = 1.84, 95% CI: 1.02–3.32) after nephrectomy. A higher Charlson comorbidity index also emerged to represent an independent risk factor for postoperative complications within 30 days (HR = 2.41, 95% CI: 1.44–4.02) and 90 days (HR = 2.23, 95% CI: 1.51–3.29) after nephrectomy. TKI treatment was not associated with an increased postoperative mortality at 30 and 90 days after surgery. Thus, TKI treatment was associated with an increased complication rate but not overall mortality following CN. Our results suggest that renal surgeons should be aware of possibly increased complications following CN in renal cell carcinoma patients, when TKI treatment is administered.

OBJECTIVE To describe the prevalence and predictors of burnout in USA and European urology residents, as although the rate of burnout in urologists is high and associated with severe negative sequelae, the extent and predictors of burnout in urology trainees remains poorly understood. SUBJECTS AND METHODS An anonymous 32-question survey of urology trainees across the USA and four European countries, analysing personal, programme, and institutional factors, was conducted. Burnout was assessed using the validated abridged Maslach Burnout Inventory. Univariate analysis and multivariable logistic regression models assessed drivers of burnout in the two cohorts. RESULTS Overall, 40% of participants met the criteria for burnout as follows: Portugal (68%), Italy (49%), USA (38%), Belgium (36%), and France (26%). Response rates were: USA, 20.9%; Italy, 45.2%; Portugal, 30.5%; France, 12.5%; and Belgium, 9.4%. Burnout was not associated with gender or level of training. In both cohorts, work-life balance (WLB) dissatisfaction was associated with increased burnout (odds ratio [OR] 4.5, P < 0.001), whilst non-medical reading (OR 0.6, P = 0.001) and structured mentorship (OR 0.4, P = 0.002) were associated with decreased burnout risk. Lack of access to mental health services was associated with burnout in the USA only (OR 3.5, P = 0.006), whilst more weekends on-call was associated with burnout in Europe only (OR 8.3, P = 0.033). In both cohorts, burned out residents were more likely to not choose a career in urology again (USA 54% vs 19%, P < 0.001; Europe 43% vs 25%, P = 0.047). CONCLUSION In this study of USA and European urology residents, we found high rates of burnout on both continents. Despite regional differences in the predictors of burnout, awareness of the unique institutional drivers may help inform directions of future interventions.

INTRODUCTION Surgical trainees experience high rates of depression and suicidal ideation (SI). However, there remain a gap in knowledge on the drivers of depression and SI in trainees, especially within the field of urology.We conducted a national study of urology trainees using a 50-item questionnaire in May 2018. The survey included demographic, depression (Patient Health Questionnaire-9 (PHQ-9)), burnout (Maslach Burnout Inventory (MBI)), and quality of life (QoL) questions.Overall, 37 (17.6%) endorsed depression; 24 residents endorsed SI (11%). SI was higher in those with depression (p0.001). Burnout was also higher among depressed residents (97.3% versus 61.8%, p0.001) and those endorsing SI (16.1% versus 1.5%, p0.001). Depression was associated with female gender (29.2% versus 12.4%, p = 0.005), fatigue (29.5% versus 7.8%, p0.001), and lack of structured mentorship (23.7% versus 9.8%, p = 0.010). Access to mental health services was protective (p = 0.016). Older age, low QoL, dissatisfaction with work-life-balance (WLB), and fatigue were associated with SI. On adjusted analysis, gender (OR 3.1 [95%CI 1.4-6.9], p = 0.006), fatigue (OR 3.8[95%CI 1.6-9.0], p = 0.002), and burnout (OR 16.7 [95%CI 2.2-127.5], p = 0.007) increased the odds of depression. On exploratory analysis, self-reported burnout alone was predictive of SI (OR 7.6 [95%CI 2.5-23]), and performed similarly to an adjusted model (AUC Area 0.718 [95%CI 0.634-0.802] versus 0.825 [0.753-0.897]).Urology trainees experience high rates of depression and SI. Female residents have significantly higher risk of depression. A single-item appears useful to screen for SI. Further investigation is needed to understand and promote urology resident wellness.

Background: Stereotactic body radiation therapy (SBRT) is a safe and effective treatment option for patients with low to intermediate risk prostate cancer (1). SBRT results in very low PSA nadirs secondary to the delivery of high biologically effective doses. Studies reporting on the diagnosis, confirmation, and management of salvageable isolated local failures (ILF) are limited. This study aims to determine the incidence and management approach of ILF after SBRT in a large single institution cohort. Method: All patients with low or intermediate risk localized prostate cancer treated with SBRT at Georgetown University Hospital were eligible for this study. Treatment was delivered using robotic SBRT with doses of 35-36.25 Gy in five fractions. ILF were diagnosed using multiparametric MRI and/or biopsy prompted by rising PSA levels after achieving long-term nadir. Patient's characteristics were extracted from a prospective institutional quality of life trial (IRB 2009-510). Type of salvage therapy and post-salvage PSA were determined on subsequent follow-up and chart review. Results: Between December 2008 to August 2018, 998 men with low to intermediate risk prostate cancer were eligible for inclusion in this analysis. Twenty-four patients (low risk, n = 5; intermediate risk, n = 19) were found to have ILF within the prostate on either MRI (n = 19) and/or biopsy (n = 20). Median pre-treatment PSA was 7.55 ng/ml. Median time to diagnosis of ILF was 72 months (24-110 months) with median PSA at the time of ILF of 2.8 ng/ml (0.7-33 ng/ml). Median PSA doubling time was 17 months (5-47 months). Thirteen patients with biopsy proven ILF proceeded with salvage therapy (cryotherapy n = 12, HIFU n = 1). Of 12 patients who underwent cryotherapy, 7 had a post-treatment PSA of

INTRODUCTION AND OBJECTIVE:Retzius-sparing robot-assisted radical prostatectomy (RS-RARP) is reported to improve urinary functional outcomes faster over standard RARP. However, there are reports of...

Background: Patients with a high pretreatment IPSS may have higher rates of late urinary morbidity after radiation therapy for prostate cancer (1). Stereotactic body radiation therapy (SBRT) delivers fewer high-dose fractions of radiation, which may be radiobiologically favorable to the conventional low-dose external beam fractions. The urinary toxicity associated with SBRT, however, remains unclear in patients with a high IPSS (1). We report our experience using SBRT for localized prostate cancer in patients with pretreatment IPSS ≥ 15. Methods: Localized prostate cancer patients with a pre-treatment IPSS ≥ 15 treated with SBRT at Georgetown University Hospital from 2009 to 2016 were included in this retrospective review of prospectively collected data. These patients were treated to 35-36.25 Gy in five fractions delivered via CyberKnife (Accuray Inc., Sunnyvale, CA). Urinary toxicity was assessed using the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4). Urinary quality of life was assessed using validated questionnaires (IPSS and EPIC-26). Results: 53 patients at a median age of 71 years (range 57-89 years) received SBRT with a minimum follow up of 3 years. The median prostate size was 37 cm3 (range 12-100 cm3) and 30.2% patients received ADT. The 3-years incidence rate of Grade 3 urinary toxicity was 7.5% with median time to toxicity of 2.9 years. There were no Grade 4 or 5 toxicities. A mean baseline IPSS score of 19.8 significantly decreased to 12.9 at 3 months post-SBRT (p = 0.002) and remained stable at 36 months (13.7). A mean baseline EPIC-26 obstructive/irritative score of 64.1 significantly improved to 80.2 at 3 months (p = 0.002). This improvement was maintained to 36 months. There was no significant change from the mean baseline EPIC-26 urinary incontinence score at any point during follow up. Conclusions: SBRT for clinically localized prostate cancer was well-tolerated in men with baseline IPSS ≥ 15 (1). Grade 3 toxicities occurred but resolved with time. Our data suggest that poor baseline urinary function does not worsen following SBRT and may even improve. High baseline IPSS score should not be considered a contraindication to SBRT.

Purpose: Retaining quality of life in patients treated with SBRT for prostate cancer remains paramount. As such, balancing the benefits of treatment against the effects of therapy on elderly patients is essential. The EORTC QLQ-ELD14 (ELD-14) is a validated questionnaire with a domain dedicated to burden of illness and treatment in the elderly. The Expanded Prostate Cancer Index Composite (EPIC)-26 is a validated questionnaire which measures urinary, bowel, sexual, and hormonal symptoms. This study reports trends in self-reported burden in patients with prostate cancer treated with SBRT and reveals convergence of self-reported burden with treatment related side effects obtained from the EPIC-26 questionnaire. Methods: All patients ≥70 years old, with localized prostate cancer treated with SBRT ± ADT at Medstar Georgetown University Hospital from 2013 to 2018 and had completed the ELD-14 were eligible for inclusion in this cross-sectional cohort study. Percentage of responses to questions related to disease and treatment burden were counted for each category ("not at all" and "a little" vs. "quite a bit" and "very much"). Additional demographic features were derived from available medical records. A total of 111 patients (median age of 74) responded to the ELD-14 questionnaire at onset of treatment and at the 2-year mark. Responses to EPIC questionnaires at matched follow-ups were scored and correlated with the self-reported burden domain of the ELD-14 using the Spearman correlation coefficient. Results: Number of patients reporting "quite a bit" or "very much" burden from prostate cancer was 6.3% prior to treatment. This was highest at 1-month (10.8%) and decreased to 9.0% at 24 months post-SBRT (X 2 = 3.836, p = 0.6986). By comparison, 3.6 and 5.4% reported "quite a bit" or "very much" burden from treatment at start of treatment and 24 months, respectively (X 2 = 1.046, p = 0.9838). Patient reported treatment burden was found to converge well with individual domains of EPIC-26. Patients undergoing ADT experienced more burden than their non-ADT counterparts. Conclusions: This cross-sectional study suggests a minority of patients reported high burden from their clinically localized prostate cancer or from their SBRT treatment. Self-reported burden converged well with lower EPIC scores in multiple domains.

To determine the prevalence of burnout in urology trainees and examine the influence of personal, programmatic, and institutional factors on burnout rates.We conducted an anonymous survey of burnout in urology residents across the United States using a 50-question REDCap-based electronic questionnaire in May of 2018. The survey included demographic questions, an inventory of stress-reduction techniques and the Maslach Burnout Inventory. Univariate analysis and multinomial logistic regression models were used to assess associations between individual, program, and organizational factors and resident burnout.Overall response rate was 20.9%. Individual factors such as age, gender, exercise, and meditation were not associated with burnout while reading for relaxation (P = .022) and spending time with family (P = .025) were protective against burnout. Residents working80 hours vs 60-80 hours and60 hours per week were more likely to exhibit burnout (77.6% vs 66.1% vs 47.1%, respectively, P = .044). Institutional factors such as structured mentorship programs (P = .019) and access to mental health services (P.001) were associated with decreased burnout. On multivariable analysis, unavailable or difficult-to-access mental health services were associated with increased odds of burnout (OR 5.38, 95%CI 2.20-13.16, P.001, and OR 2.33, 95%CI 1.07-5.07, P = .034, respectively).The prevalence of burnout in urology trainees is high. Institutional factors such as formal mentorship and access to mental health services may play an important role in resident well-being.

Patients presenting with prostate cancers undergo clinical staging evaluations to determine the extent of disease to guide therapeutic recommendations. Management options may include watchful waiting, surgery, or radiation therapy. Thus, initial risk stratification of prostate cancer patients is important for achieving optimal therapeutic results or cancer cure and preservation of quality of life. Predictive biomarkers for risks of complications or late effects of treatment are needed to inform clinical decisions for treatment selection. Here, we analyzed pre-treatment plasma metabolites in a cohort of prostate cancer patients (N = 99) treated with Stereotactic Body Radiation Therapy (SBRT) at Medstar-Georgetown University Hospital in a longitudinal, quality-of-life study to determine if individuals experiencing radiation toxicities can be identified by a molecular profile in plasma prior to treatment. We used a multiple reaction mass spectrometry-based molecular phenotyping of clinically annotated plasma samples in a retrospective outcome analysis to identify candidate biomarker panels correlating with adverse clinical outcomes following radiation therapy. We describe the discovery of candidate biomarkers, based on small molecule metabolite panels, showing high correlations (AUCs ≥ 95%) with radiation toxicities, suitable for validation studies in an expanded cohort of patients.

The utility of radical prostatectomy (RP) for locally-advanced prostate cancer remains unknown. Retrospective data has shown equivalent oncologic outcomes compared to radiation therapy (RT). RP may provide local tumor control and prevent secondary interventions from local invasion, and may decrease costs.Using SEER-Medicare data from 1995-2011 we identified men with locally-advanced prostate cancer undergoing RP or RT. Rates of post-treatment diagnoses and interventions were identified using ICD-9 and CPT codes. Skeletal related events (SRE), androgen deprivation therapy (ADT) utilization, all-cause mortality, prostate cancer-specific mortality, and costs were compared.A total of 8367 men with locally-advanced prostate cancer were identified (6200 RP, 2167 RT). RT was associated with increased urinary obstruction, hematuria, infection, and cystoscopic intervention while RP was associated with increased urethral stricture intervention and erectile dysfunction. Compared to RT, RP was associated with decreased all-cause mortality (3.1 versus 5.2 deaths/100-person-years, p0.001), prostate cancer-specific mortality (0.8 versus 2.0 deaths/100-person-years, p0.001), SREs (2.0 versus 3.4 events/100 person-years, p0.001), and ADT utilization overall (7.4 versus 33.8 doses/100-person-years, p0.001) and3 years after treatment (3.6 versus 4.6 doses/100-person-years, p0.001). Overall and cancer specific costs were significantly lower for RP versus RT.RT for locally-advanced prostate cancer has a higher incidence of mortality, secondary diagnoses and interventions, SRE, and ADT utilization compared to RP. This may lead to increased costs and have implications for quality of life. Our findings support the utility of RP in appropriately selected men with locally-advanced prostate cancer given the possible decreased morbidity and survival benefit.

Background Recent data suggest that intensity-modulated radiation therapy (IMRT) plus brachytherapy boost for unfavorable prostate cancer provides improved biochemical relapse-free survival over IMRT alone. Stereotactic body radiation therapy (SBRT) may be a less invasive alternative to brachytherapy boost. Here, we report the 3-year gastrointestinal (GI) and genitourinary (GU) toxicities of IMRT plus SBRT boost. Materials and methods Between March 2008 and September 2012, patients with prostate cancer were treated with robotic SBRT (19.5 Gy in three fractions) followed by fiducial-guided IMRT (45–50.4 Gy) on an institutional protocol. Toxicity was prospectively graded using the common terminology criteria for adverse events version 4.0 (CTCAEv.4) at the start of and at 1- to 6-month intervals after therapy. Rectal telangiectasias were graded using the Vienna Rectoscopy Score (VRS). Results At a median follow-up of 4.2 years (2.4–7.5), 108 patients (4 low-, 45 intermediate-, and 59 high-risk) with a median age of 74 years (55–92) were treated with SBRT plus IMRT, with 8% on anticoagulation and an additional 48% on antiplatelet therapy at the start of therapy. The cumulative incidence of late ≥grade 2 GI toxicity was 12%. Of these, 7% were due to late rectal bleeding, with six patients requiring up to two coagulation procedures. One patient with rectal telangiectasias was treated with hyperbaric oxygen (grade 3 toxicity). No rectal fistulas or stenoses were observed. Ten patients had multiple non-confluent telangiectasias (VRS grade 2), and three patients had multiple confluent telangiectasias (VRS grade 3). The cumulative incidence of late grade 3 GU toxicity was 6%. Most late toxicities were due to hematuria requiring bladder fulguration. There were no late ≥grade 4 GU toxicities. Conclusion Rates of clinically significant GI and GU toxicities are modest following IMRT plus SBRT boost. Future studies should compare cancer control, quality of life, and toxicity with other treatment modalities for patients with high-risk prostate cancer.

Predictors of acute urinary symptom flare following stereotactic body radiation therapy (SBRT) in the definitive treatment of localized prostate cancer

// Lymor Ringer 1,* , Paul Sirajuddin 1,* , Lucas Tricoli 1,* , Sarah Waye 1 , Muhammad Umer Choudhry 1 , Erika Parasido 1 , Angiela Sivakumar 1 , Mary Heckler 1 , Aisha Naeem 1 , Iman Abdelgawad 1,6 , Xuefeng Liu 2 , Adam S. Feldman 3 , Richard J. Lee 3 , Chin-Lee Wu 3 , Venkata Yenugonda 1 , Bhaskar Kallakury 2 , Anatoly Dritschilo 4 , John Lynch 4 , Richard Schlegel 1,2 , Olga Rodriguez 1 , Richard G. Pestell 5 , Maria Laura Avantaggiati 1,* and Chris Albanese 1,2,* 1 Department of Oncology and Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA 2 Department of Pathology, Georgetown University Medical Center, Washington, DC, USA 3 Massachusetts General Hospital, Boston, USA 4 Georgetown University Hospital, Washington, DC, USA 5 Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, USA 6 National Cancer Institute of Egypt, Cairo, Egypt * These authors contributed equally to this work Correspondence: Chris Albanese, email: // Keywords : p53, apoptosis, autophagy, primary cells, prostate Received : July 14, 2014 Accepted : September 25, 2014 Published : September 26, 2014 Abstract The p53 tumor suppressor protein plays a crucial role in influencing cell fate decisions in response to cellular stress. As p53 elicits cell cycle arrest, senescence or apoptosis, the integrity of the p53 pathway is considered a key determinant of anti-tumor responses. p53 can also promote autophagy, however the role of p53-dependent autophagy in chemosensitivity is poorly understood. VMY-1-103 (VMY), a dansylated analog of purvalanol B, displays rapid and potent anti-tumor activities, however the pathways by which VMY works are not fully defined. Using established prostate cancer cell lines and novel conditionally reprogrammed cells (CRCs) derived from prostate cancer patients; we have defined the mechanisms of VMY-induced prostate cancer cell death. Herein, we show that the cytotoxic effects of VMY required a p53-dependent induction of autophagy, and that inhibition of autophagy abrogated VMY-induced cell death. Cancer cell lines harboring p53 missense mutations evaded VMY toxicity and treatment with a small molecule compound that restores p53 activity re-established VMY-induced cell death. The elucidation of the molecular mechanisms governing VMY-dependent cell death in cell lines, and importantly in CRCs, provides the rationale for clinical studies of VMY, alone or in combination with p53 reactivating compounds, in human prostate cancer.

ObjectiveActive surveillance (AS) is an increasingly utilized strategy for monitoring men with low-risk prostate cancer (PCa) that allows them to defer active treatment (AT) in the absence of cancer progression. Studies have explored reasons for selecting AS and for then switching to AT, but less is known about men's experiences being on AS. We interviewed men to determine the clinical and psychological factors associated with selecting and adhering to AS protocols.MethodsWe conducted semi-structured interviews with men with a low-risk PCa at two academic medical centers. Subjects had either been on AS for ≥ 1 year or had opted for AT after a period of AS. We used an iterative, content-driven approach to analyze the interviews and to identify themes.ResultsWe enrolled 21 subjects, mean age 70.4 years, 3 racial/ethnic minorities, and 16 still on AS. Men recognized the favorable prognosis of their cancer (some had sought second opinions when initially offered AT), valued avoiding treatment complications, were reassured that close monitoring would identify progression early enough to be successfully treated, and trusted their urologists. Although men reported feeling anxious around the time of surveillance testing, those who switched to AT did so based only on evidence of cancer progression.ConclusionsOur selected sample was comfortable being on AS because they understood and valued the rationale for this approach. However, this highlights the importance of ensuring that men newly diagnosed with a low-risk PCa are provided sufficient information about prognosis and treatment options to make informed decisions.

BACKGROUND Routine symptom and health-related quality of life (HRQOL) assessments can engage patients, give provider feedback, and improve doctor/patient communication. OBJECTIVE We compared the impact of a technology-assisted symptom monitoring system versus usual care on HRQOL and doctor/patient communication in early-stage prostate cancer (PCa) survivors. METHODS Men (N = 94) were on average 62-years old, mostly African American (AA; 61.7%), and 10-19 months post-treatment. They were randomized to symptom monitoring plus feedback (SM + F; n = 49) or usual care (UC; n = 45). SM+F participants completed a 12-item telephoneassisted monitoring intervention. All participants completed a baseline and 2 follow-up interviews. RESULTS Among the SM+F participants, perceptions of the monitoring system were positive: 97.1% endorsed it as easy/very easy to use and 85% felt all patients could benefit from it. At baseline, men reported favorable general and cancer-specific HRQOL and doctor/patient communication, but poorer urinary and sexual function. Although there was no overall impact of the intervention, post hoc exploratory analyses indicated that among AA men, those who received SM+F improved relative to UC on doctor/patient communication (P < .05), general HRQOL (P < .06), and sexual function (P < .05). LIMITATIONS Variability in survivor follow-up care, limited access to eligible participants, and minimal physician training in the use of reports likely decreased physician investment. CONCLUSION Overall, PCa survivors were receptive to this monitoring system. Exploratory analyses suggest that this technology-assisted monitoring system may be of particular benefit to African American men. Additional studies with larger samples, more intervention time-points, and increased physician training are needed to strengthen the intervention's impact.

Laparoscopic and robotic partial nephrectomy have become the preferred option for surgical management of incidentally discovered small renal tumors. Currently there is no consensus on which aspects of the procedure should be performed laparoscopically versus robotically. We believe that combining a laparoscopic exposure and hilar dissection followed by tumor extirpation and renorrhaphy with robotic assistance provides improved perioperative outcomes compared to a pure robotic approach alone. We performed a comparison of perioperative outcomes between combined laparoscopic-robotic partial nephrectomy-or hybrid procedure-and pure robotic partial nephrectomy (RPN). A multi-center retrospective analysis of patients undergoing RPN and hybrid PN using the da Vinci S system(®) was performed. Patient data were reviewed for demographic and perioperative variables. Statistical analysis was performed using the Welch t test and linear regression, and nonparametric tests with similar significance results. Thirty-one patients underwent RPN while 77 patients underwent hybrid PN between 2007 and 2011. Preoperative variables were comparable in both groups with the exception of lesion size and nephrometry score which were significantly higher in patients undergoing hybrid PN. Length of surgery, estimated blood loss and morphine used were significantly less in the hybrid group, while warm ischemia time was significantly longer. The difference in WIT was accounted for in this data by adjusting for nephrometry score. In our multi-center series, the hybrid approach was associated with a shorter operative time, reduced blood loss and lower narcotic usage. We believe this approach is a valid alternative to RPN.

Purpose Robotic-assisted laparoscopic prostatectomy (RALP) offers reportedly comparable oncologic outcomes for localized disease compared with open radical retropubic prostatectomy (ORRP). However, the oncologic efficacy of RALP in locally-advanced prostate cancer (PCa) is less clear. We report and compare our experience with RALP and ORRP in men with locally advanced PCa. Methods Patients with locally advanced PCa (stage T3 or greater) were identified in both robotic and open cohorts. Clinicopathologic features including age, clinical stage, prostate-specific antigen, surgical margins, and Gleason score were reviewed. We further examined the incidence of positive surgical margins, the effect of the surgical learning curve on margins, and the need for adjuvant therapy. Results From 1997 to 2010, 1,011 patients underwent RALP and 415 patients were identified who underwent radical retropubic prostatectomy (RRP) across four institutions. 140 patients in the RALP group and 95 in the RRP group had locally advanced PCa on final pathology. The overall robotic positive margin rate 47.1% compared with 51.4% in the RRP group. A trend towards a lower positive margin rate was seen after 300 cases in the RALP group, with 66.7% positive margin rate in the first 300 cases compared with 41.8% in the latter 700 cases. In addition, a lower incidence of biochemical recurrence was also noted in the latter cases (30.6% vs. 9.5%). Conclusions Up to 2 out of 3 men undergoing RALP for locally-advanced PCa had positive margins during our initial experience. However, with increasing surgeon experience the overall positive margin rate decreased significantly and was comparable to the positive margin rate for patients with locally advanced disease undergoing ORRP over four academic institutions. We also noted a lower incidence of biochemical recurrence with increasing RALP experience, suggesting better oncologic outcomes with higher volume. Given this data, RALP has comparable oncologic outcomes compared to ORRP, especially with higher volume surgeons.

Background: Proctitis following prostate cancer radiation therapy is a primary determinant of quality of life (QOL). While previous studies have assessed acute rectal morbidity at 1 month after stereotactic body radiotherapy (SBRT), little data exist on the prevalence and severity of rectal morbidity within the first week following treatment. This study reports the acute bowel morbidity one week following prostate SBRT. Materials and methods: Between May 2013 and August 2014, 103 patients with clinically localized prostate cancer were treated with 35 to 36.25 Gy in five fractions using robotic SBRT delivered on a prospective clinical trial. Bowel toxicity was graded using the Common Terminology Criteria for Adverse Events version 4.0 (CTCAEv.4). Bowel QOL was assessed using EPIC-26 questionnaire bowel domain at baseline, one week, one month, and three months. Time-dependent changes in bowel symptoms were statistically compared using the Wilcoxon signed-rank test. Clinically significant change was assessed by the minimally important difference (MID) in EPIC score. This was defined as a change of one-half standard deviation (SD) from the baseline score. Results: One hundred and three patients with a minimum of three months of follow-up were analyzed. The cumulative incidence of acute grade 2 GI toxicity was 23%. There were no acute ≥ grade 3 bowel toxicities. EPIC bowel summary scores maximally declined at 1 week after SBRT (-13.9, p

Purpose/objective(s) Stereotactic body radiation therapy (SBRT) is emerging as a minimally invasive alternative to brachytherapy to deliver highly conformal, dose-­escalated radiation therapy (RT) to the prostate. SBRT alone may not adequately cover the tumor extensions outside the prostate commonly seen in unfavorable prostate cancer. External beam radiation therapy (EBRT) with high dose rate brachytherapy boost is a proven effective therapy for unfavorable prostate cancer. This study reports on early prostate-specific antigen and prostate cancer-specific quality of life (QOL) outcomes in a cohort of unfavorable patients treated with intensity-modulated radiation therapy (IMRT) and SBRT boost. Materials/methods Prostate cancer patients treated with SBRT (19.5 Gy in three fractions) followed by fiducial-guided IMRT (45–50.4 Gy) from March 2008 to September 2012 were included in this retrospective review of prospectively collected data. Biochemical failure was assessed using the Phoenix definition. Patients completed the expanded prostate cancer index composite (EPIC)-26 at baseline, 1 month after the completion of RT, every 3 months for the first year, then every 6 months for a minimum of 2 years. Results One hundred eight patients (4 low-, 45 intermediate-, and 59 high-risk) with median age of 74 years completed treatment, with median follow-up of 4.4 years. Sixty-four percent of the patients received androgen deprivation therapy prior to the initiation of RT. The 3-year actuarial biochemical control rates were 100 and 89.8% for intermediate- and high-risk patients, respectively. At the initiation of RT, 9 and 5% of men felt their urinary and bowel function was a moderate to big problem, respectively. Mean EPIC urinary and bowel function and bother scores exhibited transient declines, with subsequent return to near baseline. At 2 years posttreatment, 13.7 and 5% of men felt their urinary and bowel function was a moderate to big problem, respectively. Conclusion At 3-year follow-up, biochemical control was favorable. Acute urinary and bowel symptoms were comparable to conventionally fractionated IMRT and brachytherapy. Patients recovered to near their baseline urinary and bowel function by 2 years posttreatment. A combination of IMRT with SBRT boost is well tolerated with minimal impact on prostate cancer-specific QOL.

Background Stereotactic body radiation therapy (SBRT) delivers high doses of radiation to the prostate while minimizing radiation to the adjacent critical organs. Large fraction sizes may increase urinary morbidity due to unavoidable treatment of the prostatic urethra. This study reports rates of acute urinary morbidity following SBRT for localized prostate cancer with prophylactic alpha-adrenergic antagonist utilization and urethral dose reduction (UDR). Methods From April 2013 to September 2014, 102 patients with clinically localized prostate cancer were treated with robotic SBRT to a total dose of 35–36.25 Gy in five fractions. UDR was employed to limit the maximum point dose of the prostatic urethra to 40 Gy. Prophylactic alpha-adrenergic antagonists were initiated 5 days prior to SBRT and continued until resolution of urinary symptoms. Quality of life (QoL) was assessed before and after treatment using the American Urological Association Symptom Score (AUA) and the Expanded Prostate Cancer Index Composite-26 (EPIC-26). Clinical significance was assessed using a minimally important difference (MID) of one half SD change from baseline. Results One hundred two patients underwent definitive prostate SBRT with UDR and were followed for 3 months. No patient experienced acute urinary retention requiring catheterization. A mean baseline AUA symptom score of 9.06 significantly increased to 11.83 1-week post-SBRT (p = 0.0024) and 11.84 1-month post-SBRT (p = 0.0023) but returned to baseline by 3 months. A mean baseline EPIC-26 irritative/obstructive score of 87.7 decreased to 74.1 1-week post-SBRT (p

Although most prostatectomy studies emphasize optimal nerve-sparing dissection planes, subtle technical variation also affects functional outcomes. The impact of minimizing assistant/surgeon tension on urinary function has not been quantified. We assess urinary function after attenuating neurovascular bundle (NVB) and rhabdosphincter tension during robotic-assisted radical prostatectomy (RARP). Retrospective study of prospectively collected data for 268 (RARP-T) versus 342 (RARP-0T) men with versus without tension on the NVB and rhabdosphincter during RARP. Outcomes compared include Expanded Prostate Cancer Index (EPIC) urinary function, estimated blood loss (EBL), operative time, and positive surgical margins (PSM). In unadjusted analysis, men undergoing RARP-T versus RARP-0T were older, had higher biopsy and pathologic Gleason grade, and higher preoperative prostate specific antigen (all p ≤ 0.023). Baseline urinary function was similar. Postoperatively, RARP-0T versus RARP-T was associated with higher 5-month urinary function scores (69.7 versus 64, p = 0.049). In adjusted analyses, RARP-0T versus RARP-T was associated with improved 5-month urinary function [Parameter Estimate (PE) 7.37, Standard Error (SE) 2.67, p = 0.006], while bilateral versus non-/unilateral nerve-sparing was associated with improved 12-month urinary function and continence (both p ≤ 0.035). RARP-0T versus RARP-T was associated with shorter operative times (PE 6.66, SE 1.90, p = 0.001) and higher EBL (PE 20.88, SE 6.49, p = 0.001). There were no significant differences in PSM. While the use of tension aids in dissection of anatomic planes, avoidance of NVB counter-traction and minimizing tension on the rhabdosphincter during apical dissection attenuates neuropraxia and leads to earlier urinary function recovery. Bilateral versus non-/unilateral nerve-sparing also improves urinary function recovery.

The capacity of an individual to process DNA damage is considered a crucial factor in carcinogenesis. The comet assay is a phenotypic measure of the combined effects of sensitivity to a mutagen exposure and repair capacity. In this paper, we evaluate the association of the DNA repair kinetics, as measured by the comet assay, with prostate cancer risk. In a pilot study of 55 men with prostate cancer, 53 men without the disease, and 71 men free of cancer at biopsy, we investigated the association of DNA damage with prostate cancer risk at early (0–15 min) and later (15–45 min) stages following gamma-radiation exposure. Although residual damage within 45 min was the same for all groups (65% of DNA in comet tail disappeared), prostate cancer cases had a slower first phase (38% vs. 41%) and faster second phase (27% vs. 22%) of the repair response compared to controls. When subjects were categorized into quartiles, according to efficiency of repairing DNA damage, high repair-efficiency within the first 15 min after exposure was not associated with prostate cancer risk while higher at the 15–45 min period was associated with increased risk (OR for highest-to-lowest quartiles = 3.24, 95% CI = 0.98–10.66, p-trend = 0.04). Despite limited sample size, our data suggest that DNA repair kinetics marginally differ between prostate cancer cases and controls. This small difference could be associated with differential responses to DNA damage among susceptible individuals.

The survival advantages associated with different treatments for localized prostate cancer (PCa) continue to be uncertain. We evaluated patients' use of an interactive CD-ROM-based decision aid designed to improve informed decision making about PCa treatment. Newly diagnosed, early-stage PCa patients who had not made a treatment decision completed a baseline telephone interview (N = 132), were mailed the CD-ROM, and completed a one-month follow-up interview (N = 120; 91%). Compared to non-users (21%), CD-users (79%) preferred to make an independent rather than a shared treatment decision (OR = 3.5, CI 1.2,10.5). The majority of users (63%-90%) responded positively regarding the length and clarity of the information. Further, 76% reported using the CD as much/more than other information sources. A preference for having less decisional control predicted greater satisfaction with the CD (F[7,87] = 4.75, p.05). Electronic utilization data revealed that the topics most accessed concerned treatment information and that users spent over an hour using the CD (median = 72 minutes). This electronic educational tool was well-accepted by patients and may be particularly useful for patients who desire less control over their treatment decisions and who are less proactive in seeking information on their own.

Clinical data suggest that large radiation fractions are biologically superior to smaller fraction sizes in prostate cancer radiotherapy. The CyberKnife is an appealing delivery system for hypofractionated radiosurgery due to its ability to deliver highly conformal radiation and to track and adjust for prostate motion in real-time. We report our early experience using the CyberKnife to deliver a hypofractionated stereotactic body radiation therapy (SBRT) boost to patients with intermediate- to high-risk prostate cancer. Twenty-four patients were treated with hypofractionated SBRT and supplemental external radiation therapy plus or minus androgen deprivation therapy (ADT). Patients were treated with SBRT to a dose of 19.5 Gy in 3 fractions followed by intensity modulated radiation therapy (IMRT) to a dose of 50.4 Gy in 28 fractions. Quality of life data were collected with American Urological Association (AUA) symptom score and Expanded Prostate Cancer Index Composite (EPIC) questionnaires before and after treatment. PSA responses were monitored; acute urinary and rectal toxicities were assessed using Common Toxicity Criteria (CTC) v3. All 24 patients completed the planned treatment with an average follow-up of 9.3 months. For patients who did not receive ADT, the median pre-treatment PSA was 10.6 ng/ml and decreased in all patients to a median of 1.5 ng/ml by 6 months post-treatment. Acute effects associated with treatment included Grade 2 urinary and gastrointestinal toxicity but no patient experienced acute Grade 3 or greater toxicity. AUA and EPIC scores returned to baseline by six months post-treatment. Hypofractionated SBRT combined with IMRT offers radiobiological benefits of a large fraction boost for dose escalation and is a well tolerated treatment option for men with intermediate- to high-risk prostate cancer. Early results are encouraging with biochemical response and acceptable toxicity. These data provide a basis for the design of a phase II clinical trial.

BACKGROUND The high incidence of and few identified risk factors for prostate cancer underscore the need to further evaluate markers of prostate carcinogenesis. The aim of this pilot study was to evaluate urinary estrogen metabolites as a biomarker of prostate cancer risk. METHODS Using a liquid chromatography–tandem mass spectrometry method, urinary concentrations of 15 estrogen metabolites were determined in 77 prostate cancer cases, 77 healthy controls, and 37 subjects who had no evidence of prostate cancer after a prostate biopsy. RESULTS We observed an inverse association between the urinary 16-ketoestradiol (16-KE2) and 17-epiestriol (17-epiE3)—metabolites with high estrogenic activity—and prostate cancer risk. Men in the lowest quartile of 16-KE2, had a 4.6-fold risk of prostate cancer (OR = 4.62, 95% CI = 1.34–15.99), compared with those in the highest quartile. CONCLUSIONS We observed modest differences in estrogen metabolite concentrations between prostate cancer patients and subjects without cancer. Larger studies with both androgen and estrogen measurements are needed to confirm these results to clarify further whether estrogen metabolites are independent biomarkers for prostate cancer risk and whether androgen/estrogen imbalance influences prostate cancer risk. Prostate 77:507–516, 2011. © 2010 Wiley-Liss, Inc.

52 Background: Anxiety is a common aliment among elderly men. It may be negatively impacted by the diagnosis of cancer. Effective cancer treatment may alleviate anxiety. The EORTC QLQ-ELD14 (ELD14) is a validated questionnaire, which evaluates patient reported anxiety. Using the ELD14 questionnaire, this study assesses the trends in prostate cancer patient’s anxiety before and after treatment with SBRT. Methods: All patients with localized prostate cancer who received SBRT at Georgetown University Hospital from 2007 to 2016 were eligible for inclusion in this cross-sectional cohort. The ELD14 questionnaire was used to assess quality of life before and following treatment. Initially, approximately 267 patients (median age of 70) responded to the ELD14 questionnaire. This study is focused on questions related to patient’s anxiety regarding their families, future, health and end of life. The responses to these questions were grouped into three clinically relevant categories (not at all, a little and quite a bit to very much). Results: Prior to treatment, 19% of patients felt quite a bit or very much worried about their families coping with their illness. This decreased to 9% at 24 months post-SBRT (p = 0.007). Initially, 27% of patients reported concerns for the future of their families, which subsequently decreased to 20% at 24 months (p = 0.15). At initial consult, 32% of patients reported being worried about their future health. This decreased to 13% at 24 months (p < 0.001). Twenty percent of patient reported concern about their future at initial consult; this declined to 11% at 24 months (p = 0.03). And finally, self reported anxiety about end of life was 18% at the initial consult and 12% at 24 months (p = 0.16). Conclusions: Self-reported anxiety surrounding family, health and future is prevalent amongst prostate cancer patients at initial evaluation. Significant reduction in anxiety is observed in our cohort post-SBRT. Further investigations in the causes of pre and post-treatment anxiety may offer valuable insight into preventable root causes and improvement in patient’s quality of life.

51 Background: Retaining quality of life in patients treated with SBRT for prostate cancer remains paramount. As such, balancing the benefits of treatment against the effects of therapy on patients is essential. The quality of life is influenced by the disease and treatment related burden. The EORTC QLQ-ELD14 (ELD14) is a validated questionnaire that can assess burden. This study reports burden trends in patients with prostate cancer treated with SBRT. Methods: All patients with localized prostate cancer treated with SBRT at Georgetown University Hospital from 2007 to 2016 were eligible for inclusion in this cross-sectional cohort. The ELD14 questionnaire was used to assess self-reported patient quality of life at time points before and following treatment. Initially, 267 patients (Median age of 70) responded to the ELD14 questionnaire. Approximately 30% received ADT. The specific questions reviewed for this study were focused on burden of disease and treatment. The responses to these questions were grouped into three clinically relevant categories (not at all, a little and quite a bit to very much). Results: Number of patients reporting quite a bit or very much burden from prostate cancer declined over time from 13% prior to treatment to 8% at 36 months post-SBRT. This was highest at one month post-SBRT (15%) and resolved to baseline by 6 months. Treatment burden similarly decreased over time from 10% to 3%. Patients treated with androgen deprivation therapy (ADT) experienced greater burden than others. At initial consult, 19% of patients on ADT reported quite a bit or very much burden from their illness. At one month post-SBRT, this had increased to 27% and subsequently decreased to 16% at 36 months. Of those not receiving ADT, 12% reported having quite a bit or very much burden from illness initially, 9% at one month and 6% at 36 months. Conclusions: This cross-sectional study suggests that the burden of clinically localized prostate and its treatment with SBRT improves over time. Increased burden was noted in patients receiving ADT. These findings can inform decision making in improving quality of life for patients with prostate cancer treated with SBRT.

In several developed countries intermittent androgen deprivation therapy has been accepted over continuous androgen deprivation therapy for advanced prostate cancer management. To our knowledge its adoption and predictors of use in American urology practice remain unknown.Using SEER-Medicare data we identified a cohort of men 66 years old or older who were newly diagnosed with prostate cancer with metastasis or with treated recurrence in whom androgen deprivation therapy was started during 2003 to 2007. We determined intermittent androgen deprivation therapy receipt based on interruptions longer than 3 months between scheduled and actual therapy injections, and physician visits and prostate specific antigen tests during the interruption. Predictors included patient and physician characteristics. We performed logistic regression analysis separately in the metastatic and treated recurrence groups using generalized estimating equations to account for the clustering effect of patients treated by the same physician.Our cohort included 4,281 men, of whom 2,487 with metastasis and 1,794 with treated recurrence received intermittent androgen deprivation therapy. In patients who received intermittent rather than continuous therapy the median duration of therapy was by 6.4 and 9.0 months longer in those with metastasis and treated recurrence, respectively. Each patient group showed significant variation in intermittent therapy use by region (p0.0001). There was lower intermittent androgen deprivation therapy use in the Eastern and Central regions than in the Mountain and Pacific regions.Intermittent androgen deprivation therapy has not been widely used in American urology practice. Its adoption shows substantial variation by geographic regions. These regional differences likely reflect uncertainty regarding the efficacy of this therapy among providers as well as differences in patient preferences and involvement in treatment decision making.

Purpose: Magnetic resonance imaging (MRI)-directed stereotactic body radiation therapy (SBRT) has been established as a safe and effective treatment for prostate cancer. For patients with contraindications to MRI, CT-urethrogram is an alternative imaging approach to identify the location of the prostatic apex to guide treatment. This study sought to evaluate the safety of urethrogram-directed SBRT for prostate cancer.Methods: Between February 2009 and January 2014, 31 men with clinically localized prostate cancer were treated definitively with urethrogram-directed SBRT with or without supplemental intensity modulated radiation therapy (IMRT) at Georgetown University Hospital. SBRT was delivered either as a primary treatment of 35-36.25 Gray (Gy) in 5 fractions or as a boost of 19.5 Gy in 3 fractions followed by supplemental conventionally fractionated intensity modulated radiation therapy (45-50.4 Gy). Toxicities were recorded and scored using the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v.4.0).Results: The median patient age was 70 years with a median prostate volume of 38 cc. The median follow-up was 3.7 years. The patients were elderly (Median age = 70), and comorbidities were common (Carlson Comorbidity Index > 2 in 36%). 71% of patients utilized alpha agonists prior to treatment, and 9.7% had prior procedures for benign prostatic hyperplasia (BPH). The 3-year actuarial incidence rates of > Grade 3 GU toxicity and > Grade 2 GI toxicity were 3.2% and 9.7%, respectively. There were no Grade 4 or 5 toxicities.Conclusions: MRI is the preferred imaging modality to guide prostate SBRT treatment. However, urethrogram-directed SBRT is a safe alternative for the treatment of patients with prostate cancer who are unable to undergo MRI.

Background Dysuria following prostate radiation therapy is a common toxicity that adversely affects patients’ quality of life and may be difficult to manage. Methods Two hundred four patients treated with stereotactic body radiation therapy (SBRT) from 2007 to 2010 for localized prostate carcinoma with a minimum follow-up of 3 years were included in this retrospective review of prospectively collected data. All patients were treated to 35–36.25 Gy in five fractions delivered with robotic SBRT with real time fiducial tracking. Dysuria and other lower urinary tract symptoms were assessed via Question 4b (Pain or burning on urination) of the expanded prostate index composite-26 and the American Urological Association (AUA) Symptom Score at baseline and at routine follow-up. Results Two hundred four patients (82 low-, 105 intermediate-, and 17 high-risk according to the D’Amico classification) at a median age of 69 years (range 48–91) received SBRT for their localized prostate cancer with a median follow-up of 47 months. Bother associated with dysuria significantly increased from a baseline of 12% to a maximum of 43% at 1 month (p

Purpose: Stereotactic body radiation therapy (SBRT) is increasingly utilized as primary treatment for clinically localized prostate cancer. Consensus regarding the appropriate patient-reported outcome (PRO) endpoints for clinical trials evaluating radiation modalities for early stage prostate cancer is lacking. To aid in clinical trial design, this study presents PROs over a 36-month period following SBRT for clinically localized prostate cancer. Methods: Between February 2008 and September 2010, 174 hormone-naïve patients with clinically localized prostate cancer were treated with 35–36.25 Gy SBRT (CyberKnife, Accuray) delivered in 5 fractions. Patients completed the validated Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire at baseline and all follow-ups. The proportion of patients developing a clinically significant decline in each EPIC domain score was determined. The minimally important difference (MID) was defined as a change of one-half the standard deviation from the baseline. Per Radiation Therapy Oncology Group (RTOG) 0938, we also examined the patients who experienced a decline in EPIC urinary domain summary score of >2 points (unacceptable toxicity defined as ≥60% of all patients reporting this degree of decline) and EPIC bowel domain summary score of >5 points (unacceptable toxicity defined as >55% of all patients reporting this degree of decline) from baseline to 1 year. Results: A total of 174 patients at a median age of 69 years received SBRT with a minimum follow-up of 36 months. The proportion of patients reporting a clinically significant decline (MID for urinary/bowel are 5.5/4.4) in EPIC urinary/bowel domain scores was 34%/30% at 6 months, 40%/32.2% at 12 months, and 32.8%/21.5% at 36 months. The patients reporting a decrease in the EPIC urinary domain summary score of >2 points was 43.2% (CI: 33.7%, 54.6%) at 6 months, 51.6% (CI: 43.4%, 59.7%) at 12 months, and 41.8% (CI: 33.3%, 50.6%) at 36 months. The patients reporting a decrease in the EPIC bowel domain summary score of >5 points was 29.6% (CI: 21.9%, 39.3%) at 6 months, 29% (CI: 22%, 36.8%) at 12 months, and 22.4% (CI: 15.7%, 30.4%) at 36 months. Conclusion: Following prostate SBRT, clinically significant urinary symptoms are more common than bowel symptoms. Our prostate SBRT treatment protocol meets the RTOG 0938 criteria for moving forward to a Phase III trial comparing it to conventionally fractionated radiation therapy. Notably, between 12 and 36 months, the proportion of patients reporting a significant decrease in both EPIC urinary and bowel domain scores declined, suggesting a late improvement in these symptom domains. Further investigation is needed to elucidate (1) which EPIC domains bear the greatest influence on post-treatment quality of life and (2) at what time point PRO endpoint(s) should be assessed.

Background Hematuria following prostate radiotherapy is a known toxicity that may adversely affect a patient’s quality of life. Given the higher dose of radiation per fraction using stereotactic body radiation therapy (SBRT) there is concern that post-SBRT hematuria would be more common than with alternative radiation therapy approaches. Herein, we describe the incidence and severity of hematuria following stereotactic body radiation therapy (SBRT) for prostate cancer at our institution. Methods Two hundred and eight consecutive patients with prostate cancer treated with SBRT monotherapy with at least three years of follow-up were included in this retrospective analysis. Treatment was delivered using the CyberKnife® (Accuray) to doses of 35–36.25 Gy in 5 fractions. Toxicities were scored using the CTCAE v.4. Hematuria was counted at the highest grade it occurred in the acute and late setting for each patient. Cystoscopy findings were retrospectively reviewed. Univariate and multivariate analyses were performed. Hematuria-associated bother was assessed via the Expanded Prostate Index Composite (EPIC)-26. Results The median age was 69 years with a median prostate volume of 39 cc. With a median follow-up of 48 months, 38 patients (18.3%) experienced at least one episode of hematuria. Median time to hematuria was 13.5 months. In the late period, there were three grade 3 events and five grade 2 events. There were no grade 4 or 5 events. The 3-year actuarial incidence of late hematuria ≥ grade 2 was 2.4%. On univariate analysis, prostate volume (p = 0.022) and history of prior procedure(s) for benign prostatic hypertrophy (BPH) (p = 0.002) were significantly associated with hematuria. On multivariate analysis, history of prior procedure(s) for BPH (p

Background: Laparoscopic and robotic simple prostatectomy (SP) have been introduced with the aim of reducing the morbidity of the standard open technique. Objective: To report a large multi-institutional series of minimally invasive SP (MISP). Design, setting, and participants: Consecutive cases of MISP done for the treatment of bladder outlet obstruction (BOO) due to benign prostatic enlargement (BPE) between 2000 and 2014 at 23 participating institutions in the Americas and Europe were included in this retrospective analysis. Intervention: Laparoscopic or robotic SP. Outcome measurements and statistical analysis: Demographic data and main perioperative outcomes were gathered and analyzed. A multivariable analysis was conducted to identify factors associated with a favorable trifecta outcome, arbitrarily defined as a combination of the following postoperative events: International Prostate Symptom Score 15 ml/s, and no perioperative complications. Results and limitations: Overall, 1330 consecutive cases were analyzed, including 487 robotic (36.6%) and 843 laparoscopic (63.4%) SP cases. Median overall prostate volume was 100 ml (range: 89-128). Median estimated blood loss was 200 ml (range: 150-300). An intraoperative transfusion was required in 3.5% of cases, an intraoperative complication was recorded in 2.2% of cases, and the conversion rate was 3%. Median length of stay was 4 d (range: 3-5). On pathology, prostate cancer was found in 4% of cases. Overall postoperative complication rate was 10.6%, mostly of low grade. At a median follow-up of 12 mo, a significant improvement was observed for subjective and objective indicators of BOO. Trifecta outcome was not significantly influenced by the type of procedure (robotic vs laparoscopic; p = 0.136; odds ratio [OR]: 1.6; 95% confidence interval [CI], 0.8-2.9), whereas operative time (p = 0.01; OR: 0.9; 95% CI, 0.9-1.0) and estimated blood loss ( p = 0.03; OR: 0.9; 95% CI, 0.9-1.0) were the only two significant factors. Retrospective study design, lack of a control arm, and limited follow-up represent major limitations of the present analysis. Conclusions: This study provides the largest outcome analysis reported for MISP for BOO/BPE. These findings confirm that SP can be safely and effectively performed in a minimally invasive fashion in a variety of healthcare settings in which specific surgical expertise and technology is available. MISP can be considered a viable surgical treatment in cases of large prostatic adenomas. The use of robotic technology for this indication can be considered in centers that have a robotic program in place for other urologic indications. Patient summary: Analysis of a large data set from multiple institutions shows that surgical removal of symptomatic large prostatic adenomas can be carried out with good outcomes by using robot-assisted laparoscopy.