Clinical Localized Prostate Cancer Research Articles

Utility of positive core number on MRI-ultrasound fusion targeted biopsy in combination with PI-RADS scores for predicting unexpected extracapsular extension of clinically localized prostate cancer.

To evaluate the utility of magnetic resonance imaging (MRI) and MRI-ultrasound fusion targeted biopsy (TB) for predicting unexpected extracapsular extension (ECE) in clinically localized prostate cancer (CLPC). This study enrolled 89 prostate cancer patients with one or more lesions showing a Prostate Imaging-Reporting and Data System (PI-RADS) score ≥3 but without morphological abnormality in the prostatic capsule on pre-biopsy MRI. All patients underwent TB and systematic biopsy followed by radical prostatectomy (RP). Each lesion was examined by 3-core TB, taking cores from each third of the lesion. The preoperative variables predictive of ECE were explored by referring to RP specimens in the lesion-based analysis. Overall, 186 lesions, including 81 (43.5%), 73 (39.2%), and 32 (17.2%) with PI-RADS 3, 4, and 5, respectively, were analyzed. One hundred and twenty-two lesions (65.6%) were diagnosed as cancer on TB, and ECE was identified in 33 (17.7%) on the RP specimens. The positive TB core number was ≤2 in 129 lesions (69.4%) and three in 57 lesions (30.6%). On the multivariate analysis, PI-RADS ≥4 (p = 0.049, odds ratio [OR] = 2.39) and three positive cores on TB (p = 0.005, OR = 3.07) were independent predictors of ECE. Lesions with PI-RADS ≥4 and a positive TB core number of 3 had a significantly higher rate of ECE than those with PI-RADS 3 and a positive TB core number ≤2 (37.5% vs. 7.8%, p < 0.001). Positive TB core number in combination with PI-RADS scores is helpful to predict unexpected ECE in CLPC.

15-year biochemical failure, metastasis, salvage therapy, and cancer-specific and overall survival rates in men treated with robotic radical prostatectomy for PSA-screen detected prostate cancer.

An informed decision regarding a treatment option requires data on its long-term efficacy and side-effect profile. While the side-effects of robotic radical prostatectomy have been well-quantified, the data on its long-term efficacy are lacking. We here provide 15-year oncological outcomes of clinically-localized prostate cancer (CLPCa) patients treated with robot-assisted laparoscopic prostatectomy (RALP). We treated 1,807 men with CLPCa with RALP between 2001 and 2005 and prospectively collected follow-up data through 2020. We examined the rates of biochemical failure (BCF), metastatic progression, secondary therapy use, PCa-specific mortality (PCSM), and overall survival (OS) using Kaplan-Meier and competing-risk cumulative incidence methods as appropriate. The median follow-up was 14.1 years. Six hundred eight and 312 men had D'Amico intermediate- and high-risk disease, respectively. Overall, the 15-year rates of BCF, metastasis, secondary therapy use, PCSM, and OS were 28.1%, 4.0%, 16.3%, 2.5%, and 82.1%, respectively. The rates of oncologic failure increased with increasing D'Amico (preoperative) and Diaz (postoperative) risk scores - BCF, metastasis, and PCSM rates in D'Amico low-, intermediate-, and high-risk groups at 15-years were 15.2%, 38.3%, and 44.1% [BCF], 1.1%, 4.1%, and 13.0% [metastasis], and 0.5%, 3.4%, and 6.6% [PCSM], respectively, and in Diaz risk groups 1, 2, 3, 4, and 5 were 5.5%, 20.6%, 41.8%, 66.9%, and 89.2% [BCF], 0%, 0.5%, 3.2%, 20.5%, and 60.0% [metastasis], and 0%, 0.8%, 0.6%, 13.5%, and 37.5% [PCSM], respectively. The OS rates in D'Amico low-to-high and Diaz 1-to-5 risk groups at 15-years were 85.9%, 78.6%, and 75.2%, and 89.4%, 83.2%, 80.6%, 67.2%, and 23.4%, respectively. Men diagnosed with clinically-localized prostate cancer in the contemporaneous PSA-screening era and treated with RALP achieve durable long-term oncological control. The data reported here (in a risk-stratified manner) represent the longest follow-up after robotic radical prostatectomy, and as such, should be of value when counseling patients regarding expected oncologic outcomes from RALP.

MP67-04 VALIDATION OF NOVEL PREOPERATIVE RISK CATEGORIES ON THE PREDICTION OF CLINICAL RECURRENCE IN PATIENTS CANDIDATE FOR RADICAL PROSTATECTOMY FOR CLINICALLY LOCALIZED PROSTATE CANCER. RESULTS OF A LARGE, MULTI-INSTITUTIONAL SERIES

You have accessJournal of UrologyCME1 Apr 2023MP67-04 VALIDATION OF NOVEL PREOPERATIVE RISK CATEGORIES ON THE PREDICTION OF CLINICAL RECURRENCE IN PATIENTS CANDIDATE FOR RADICAL PROSTATECTOMY FOR CLINICALLY LOCALIZED PROSTATE CANCER. RESULTS OF A LARGE, MULTI-INSTITUTIONAL SERIES Elio Mazzone, Giorgio Gandaglia, Francesco Barletta, Andrea Necchi, Daniele Raggi, Laura Marandino, Armando Stabile, Vito Cucchiara, Giuseppe Rosiello, Gabriele Sorce, Francesco Pellegrino, Simone Scuderi, Daniele Robesti, Mario De Angelis, Antony Pellegrino, Mattia Longoni, Pietro Scilipoti, Francesco Montorsi, and Alberto Briganti Elio MazzoneElio Mazzone More articles by this author , Giorgio GandagliaGiorgio Gandaglia More articles by this author , Francesco BarlettaFrancesco Barletta More articles by this author , Andrea NecchiAndrea Necchi More articles by this author , Daniele RaggiDaniele Raggi More articles by this author , Laura MarandinoLaura Marandino More articles by this author , Armando StabileArmando Stabile More articles by this author , Vito CucchiaraVito Cucchiara More articles by this author , Giuseppe RosielloGiuseppe Rosiello More articles by this author , Gabriele SorceGabriele Sorce More articles by this author , Francesco PellegrinoFrancesco Pellegrino More articles by this author , Simone ScuderiSimone Scuderi More articles by this author , Daniele RobestiDaniele Robesti More articles by this author , Mario De AngelisMario De Angelis More articles by this author , Antony PellegrinoAntony Pellegrino More articles by this author , Mattia LongoniMattia Longoni More articles by this author , Pietro ScilipotiPietro Scilipoti More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , and Alberto BrigantiAlberto Briganti More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003330.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Most of the preoperative risk tools predicting prostate cancer (PCa) recurrence after radical prostatectomy (RP) considered biochemical recurrence (BCR) as the main endpoint when developed. However, not all patients with a BCR ultimately progress to clinical recurrence (CR). We aimed at internally validating a novel preoperative risk classification in predicting CR in patients treated with RP. METHODS: Overall, 2,901 patients treated with RP and who received pre-op mpMRI between 2014 -2022 at eight referral centers were identified. The study outcome was 5-yr CR defined as positive imaging after BCR. Kaplan-Meier and multivariable Cox regression models tested time and predictors of CR. Predictors consisted of PSA, biopsy grade group, MRI stage (organ-confined vs extracapsular extension vs. seminal vesicles invasion) and maximum diameter of lesion at MRI. These variables defined four risk groups based on the novel classification. The tool accuracy was compared to the EAU risk classification and CAPRA score in predicting 5-year CR using Harrel’s c-index. Decision curve analyses (DCA) compared the net-benefit associated with each of the risk tools. RESULTS: Overall, 937 (32%), 1006 (35%), 848 (30%) and 110 (3%) had low, intermediate, high and very-high risk disease according to the novel classification. Median follow-up was 43 months. At KM analyses, 5-year CR-free survival rates were 94, 90, 83 and 71% in, respectively, low, intermediate, high and very-high risk groups (p<0.01). The novel model tested for prediction CR in Cox regression analyses depicted good discrimination at internal validation (c-index 76%). After testing the accuracy of the EAU risk groups and the CAPRA score in our cohort, the novel model showed higher c index (78 vs. 69 vs. 73%). At DCA, our novel model showed a higher net-benefit compared to other models (Figure 1). CONCLUSIONS: We internally validated a novel preoperative risk tool to predict CR after RP. Our model exhibited higher accuracy as compared to available tools in the prediction of stronger oncologic endpoints at mid-term follow-up. This data reinforces the utility of this patient stratification for preoperative counselling and outcome predictions. Source of Funding: no © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e944 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Elio Mazzone More articles by this author Giorgio Gandaglia More articles by this author Francesco Barletta More articles by this author Andrea Necchi More articles by this author Daniele Raggi More articles by this author Laura Marandino More articles by this author Armando Stabile More articles by this author Vito Cucchiara More articles by this author Giuseppe Rosiello More articles by this author Gabriele Sorce More articles by this author Francesco Pellegrino More articles by this author Simone Scuderi More articles by this author Daniele Robesti More articles by this author Mario De Angelis More articles by this author Antony Pellegrino More articles by this author Mattia Longoni More articles by this author Pietro Scilipoti More articles by this author Francesco Montorsi More articles by this author Alberto Briganti More articles by this author Expand All Advertisement PDF downloadLoading ...

Association between pelvic nodal radiotherapy and patient-reported functional outcomes through 5 years among men undergoing external-beam radiotherapy for prostate cancer: An assessment of the comparative effectiveness analysis of surgery and radiation (CEASAR) cohort.

The role of pelvic irradiation in men receiving external beam radiotherapy (EBRT) for prostate cancer is unclear, in part due to a lack of data on patient-reported outcomes. We sought to compare functional outcomes for men receiving prostate and pelvic versus prostate-only radiotherapy, longitudinally over 5 years. We performed a population-based, prospective cohort study of men with clinically-localized prostate cancer undergoing EBRT. We examined the effect of prostate and pelvic (n = 102) versus prostate-only (n = 485) radiotherapy on patient-reported disease-specific (using the Expanded Prostate Cancer Index Composite[EPIC]-26) and general health-related (using the SF-36) function, over 5 years. Regression models were adjusted for outcome-specific baseline function, clinicopathologic characteristics, and androgen deprivation therapy (ADT). 587 men (median [quartiles] age 69 [64-73] years) met inclusion criteria and completed ≥1 post-treatment survey. More men treated with prostate and pelvic radiotherapy had high-risk disease (58% vs. 18%, P < 0.01) and received ADT (75% vs. 41%, P < 0.01). These men reported worse sexual (6 months-5 years), hormonal (at 6 months), and physical (6 months-5 years) function. Accounting for baseline function, patient and tumor characteristics, and use of ADT, pelvic irradiation was not associated with statistically or clinically significant differences in bowel function, urinary incontinence, irritative voiding symptoms or sexual function through 5-years (all P > 0.05). Marginally clinically important differences were noted in hormonal function at 3-years (adjusted mean difference 4.7, 95% confidence interval [1.2-8.3]; minimally clinically important difference (MCID) 4 to 6) and 5-years (4.2, [0.4-8.0]) following treatment. After adjustment, there was a transient statistically significant, but not clinically important, difference in emotional well-being at 6 months (3.0, [0.19-5.8]; MCID 6) that resolved by 1 year and no differences in physical functioning or energy and fatigue. This prospective, population-based cohort study of men with localized prostate cancer treated with EBRT, showed no clinically important differences in disease-specific or general health-related quality of life with the addition of pelvic irradiation to prostate radiotherapy, supporting the use of pelvic radiotherapy when it may be of clinical benefit, such as men with increased risk of nodal involvement.

Conventional dose versus dose escalated radiotherapy including high-dose-rate brachytherapy boost for patients with Gleason score 9\u201310 clinical localized prostate cancer

As several recent researches focus on the importance of Gleason 9–10, we examine the role of radiotherapy dose escalation in those patients. We analyzed 476 patients with Gleason score 9–10 prostate cancer treated with radiotherapy. Of them, 127 patients were treated with conventional-dose external beam radiotherapy (Conv RT) and 349 patients were treated with high-dose radiotherapy (HDRT; 249 patients received high-dose-rate brachytherapy boost + external beam radiotherapy [HDR boost] and 100 patients received intensity-modulated radiotherapy [IMRT]). We compared these treatment groups using multi-institutional retrospective data. The patients had a median follow-up period of 66.3 months. HDRT showed superior biochemical disease-free survival (bDFS) rate (85.2%; HDR boost 84.7% and IMRT 86.6%) to Conv RT (71.1%, p < 0.0001) at 5 years, with a hazard ratio of 0.448. There were borderline difference in prostate cancer-specific mortality (PCSM; 4.3% and 2.75%, p = 0.0581), and distant metastasis-free survival (DMFS; 94.4% and 89.6%, p = 0.0916) rates at 5-years between Conv RT and HDRT group. Dose escalated radiotherapy showed better bDFS, borderline improvement in PCSM, and equivocal outcome in DMFS in with clinically localized Gleason 9–10 prostate cancer.

HIGH RISK PROSTATE CANCER: COMPARISON OF RADICAL PROSTATECTOMY VERSUS RADIATION THERAPY: EXPERIENCE OF MILITARY HOSPITAL RABAT

Context: To date, there is no Level 1 evidence comparing the efficacy of radical prostatectomy and radiotherapy for patients with clinically-localized prostate cancer. Objective: to evaluate overall survival (OS) and relapse free survival of high risk prostate cancer (PCa) treated either with external beam radiotherapy (EBRT) associated with androgen deprivation therapy (ADT) or radical prostatectomy (RP) with adjuvant or salvage radiotherapy and ADT. Also, it is very interesting to compare different acute and late toxicity of the both approach. Materials and Methods: During a period of 10 years from April 2009 and December 2018, 149 patients with high-risk prostate cancer were admitted to the radiotherapy department of the Mohammed V military hospital in Rabat (HMIMV). Among these patients, 17 underwent surgery followed by EBRT and ADT: this is the experimental arm (Group I) and 34 patients who had benefited from treatment with EBRT with ADT were selected from the other patients by a 1: 2 matching method who will represent the reference group (Group II) to allow a comparison with the experimental arm with the minimum possible bias. Results: The overall survival (OS) at 5 and 10 years was 100 % in the both arms while relapse free survival at 5 years was 91,7 % and 93,1% respectively in group I and II and at 10 years 91,7% in the group multimodal approach and 88,9 % in the EBRT+ADT group without any significant difference. We note more toxicities in the surgical group with more urinary incontinence (p=0,001) and more erectile dysfunction. Conclusion: RP with adjuvant EBRT and EBRT+ADT provided similar long-term cancer control for patients with high-risk prostate cancer but with different toxicity profiles.

Clinical-Genomic Sub-classification of High-Risk Prostate Cancer: Implications for Tailoring Therapy and Clinical Trial Design

Current risk stratification schema have limited prognostic value in predicting outcome in clinical high-risk localized (T3-T4, Gleason 8-10, or PSA > 20 ng/mL) prostate cancer. We sought to develop an optimized clinical-genomic risk stratification system tailored for high-risk disease. Two multicenter high-risk cohorts were used for training (n = 214) and validation (n = 151) of a novel integrated clinical-genomic Classifier Optimized for Outcome in High-risk Prostate cancer (COOHP) to classify patients as COOHP favorable high-risk, standard high-risk, or very high-risk. A prospectively collected cohort of patients with high-risk prostate cancer (n = 1,056) was used for reclassification analyses. Cox regression analysis was used to model metastasis-free survival (MFS) and overall survival (OS). Model performance was compared to prior sub-classification systems (three-tiered clinical and CAPRA) using c-indices. Among clinical high-risk patients managed with radical prostatectomy in the training cohort, 11% were reclassified as COOHP favorable high-risk disease, 70% as COOHP standard high-risk disease, and 18% as COOHP very high-risk disease. In the training cohort, COOHP significantly discriminated 5-year MFS among the three groups (94% vs 76% vs 34%, p < 0.05 for pairwise comparisons). In the validation cohort, COOHP significantly predicted 8-year MFS (100% vs 79% vs 58%, p < 0.05) and 10-year OS (100% vs 71% vs 53%, p < 0.05) among the three groups. The c-indices for COOHP in the validation cohort were 0.66 for predicting 8-year MFS and 0.71 for predicting 10-year OS. In contrast, the c-indices for prior sub-classification systems ranged from 0.44-0.50 for 8-year MFS and 0.64-0.65 for 10-year OS. In a prospective cohort, 22.2%, 63.4%, and 14.4% of patients were classified as COOHP favorable, standard, and very high-risk, respectively. A clinical-genomic risk stratification system specifically designed to discriminate prognosis in high-risk prostate cancer better identified favorable high-risk and very high-risk subsets of disease compared to prior stratification systems. Once further validated, this system could be used to counsel patients, to individualize the intensity of treatment, and to improve clinical trial design.

1114 - When to omit lymphadenectomy during radical prostatectomy in patients with clinical localized prostate cancer: A clinical net benefit analysis weighting staging accuracy, risk of morbidity and life expectancy

1114 - When to omit lymphadenectomy during radical prostatectomy in patients with clinical localized prostate cancer: A clinical net benefit analysis weighting staging accuracy, risk of morbidity and life expectancy

Active surveillance for low-risk prostate cancer - in pursuit of a standardized protocol.

IntroductionActive surveillance (AS) is a management option recommended by most guidelines for low risk clinically-localized prostate cancer (LR-CLPC). Data shows that AS is being increasingly adopted into clinical practice worldwide. Our aim was to review the up-to date guidelines and observational studies in regards to AS in LR-CLRPC to gain insight into principles of contemporary clinical practice.Material and methodsSeveral guidelines on the management of low-risk prostate cancer were reviewed for evidence-based recommendations regarding the protocol of AS. We reviewed the available literature for most recent studies on AS in LR-CLPC.ResultsNo uniform protocol of AS in LR-CLPC has been recommended up to date and available guidelines significantly differ in terms of protocol schedules and the role of particular tools in monitoring for disease progression. Nevertheless, recent studies on AS in LR-CLPC, in which various protocols were adopted, have demonstrated promising outcomes in regards to cancer-specific survival (99–100% at 5 years, 98.1–99.9% at 10 years, and 94.3–96% at 15 years), with high rates of men remaining within the protocols (23–39% at 10 years).ConclusionsThis article is a call for focusing further research on development and recommending a precise and standardized, evidence-based protocol for AS in LR-CLPC.

Are urologic surgeons performing robot-assisted radical prostatectomy at the University of Alberta meeting surgical quality performance benchmarks? The PROCURE-02 quality assurance study.

Robot-assisted radical prostatectomy (RARP) is a standard of care primary treatment for men with clinically localized prostate cancer (CLPC). The 2010 Canadian Urological Association (CUA) consensus guideline examining surgical quality performance for radical prostatectomy suggested benchmarks for surgical performance. To date, no study has examined whether Canadian surgeons are achieving these benchmarks. We determined the proportion of University of Alberta (UA) urologic surgeons achieving the CUA surgical quality performance outcome (SQPO) benchmarks. A retrospective quality assurance analysis of prospectively collected data from the PROstate Cancer Urosurgery Repository of Edmonton (PROCURE) was performed. Men who underwent RARP for CLPC between September 2007 and May 2018 by one of seven surgeons were analyzed. SQPO were an unadjusted pT2-R1 resection rate <25%, blood transfusion rate <10%, rectal injury rate <1%, and 90-day mortality rate <1%. Descriptive statistics were used to determine the proportion of surgeons achieving the benchmarks. Data were evaluable for 2821 men. Seven of seven (100%) surgeons achieved a blood transfusion rate <10%, rectal injury rate <1%, and 90-day mortality rate <1%. However, only six of seven surgeons achieved an unadjusted pT2-R1 resection rate <25%; one surgeon had an unadjusted pT2-R1 resection rate of 27.9%. Limitations include the lack of centralized pathology review for surgical margin status by a dedicated genitourinary pathologist. UA surgeons are achieving the CUA SQPO benchmarks for blood transfusion, rectal injury, and perioperative mortality. However, not all UA urologists are achieving a pT2-R1 resection rate <25%. Surgical quality performance initiatives designed to improve cancer control may be warranted.

SC180 - Time from biochemical to clinical recurrence should be considered as a proxy of overall survival in patients with clinically-localized prostate cancer who experience recurrence after radical prostatectomy

SC180 - Time from biochemical to clinical recurrence should be considered as a proxy of overall survival in patients with clinically-localized prostate cancer who experience recurrence after radical prostatectomy

Randomized trial evaluating the role of weight loss in overweight and obese men with early stage prostate Cancer on active surveillance: Rationale and design of the Prostate Cancer Active Lifestyle Study (PALS)

Active surveillance (AS) is increasingly used to monitor patients with low-risk prostate cancer; however, approximately 50% of AS patients experience disease reclassification requiring definitive treatment and little is known about patient characteristics that modify the risk of reclassification. Obesity may be one of the major contributing factors.The Prostate Cancer Active Lifestyle Study (PALS) is a clinical trial evaluating the impact of weight loss among overweight/obese (Body Mass Index (BMI) ≥ 25 kg/m2) men with clinically localized prostate cancer on AS. Two hundred participants will be randomized to either the PALS intervention, a 6-month structured diet and exercise program adapted from the Diabetes Prevention Program followed by 6 months of maintenance, or control (general diet and physical activity guidelines delivered in a single session). The PALS intervention involves one-on-one instruction with a registered dietitian and exercise physiologist to achieve the study goal of loss of 7% of baseline weight. Participation is coordinated so that the 6-month time point coincides with the participants' standard-of-care AS prostate biopsy. Primary outcomes will evaluate the intervention effects on circulating and tissue markers of glucose and insulin regulation, health-related quality of life and pathologic upgrading on follow-up prostate biopsies. Additional analyses will determine whether changes in weight and glucose regulation can be sustained for 6 months after the end of instruction. Findings from this trial may have wide reaching implications for men diagnosed with clinically-localized prostate cancer by providing an active lifestyle-based approach to improve prostate cancer patient outcomes.

Robotic laparoendoscopic single-site radical prostatectomy (R-LESS-RP) with daVinci Single-Site® platform. Concept and evolution of the technique following an IDEAL phase 1

To describe the evolution of robotic laparoendoscopic single-site radical prostatectomy (R-LESS-RP) performed with the daVinci Single-Site Platform® and a home-made multiport aimed to overcome classical drawbacks of LESS, still present with this platform. Between 09/2015 and 06/2017 12 patients underwent R-LESS RP for clinical localized prostate cancer. Following a "phase 1 (development-stage)" innovation, development, exploration, assessment, long-term study (IDEAL) framework, different solutions were drawn to overcome drawbacks of daVinci Single-Site Platform®, included 3 (A, B, and C) multi-ports developed and evaluated in term of advantages/drawbacks concerning ergonomy. The end points of this study were: feasibility, safety, efficacy, by reporting rational description of multiports configuration, demographics, perioperative variables, functional and oncological results. Semi-flexible robotic 5-mm needle-holder instead of Maryland forceps, 30° lenses up and barbed-suture allowed overcoming limits of robotic-platform. Multiport-C (GelPOINT Advanced-Access® and an extra 8-mm robotic trocar outside the multiport) showed the best compromise to ensure both surgeon and bed-side assistant to reproduce a standard robotic procedure. No conversion to either standard robotic or open technique or intraoperative complications occur in any case. Two patients experienced "high-grade" Clavien-Dindo complications. After 12.4 months follow-up, all patients were continent without any sign of biochemical relapse and among 5 preoperative potent patients submitted to nerve-sparing dissection, 4 reported good erectile-function. R-LESS-RP is feasible and safe in the hands of experienced minimally-invasive surgeons. Do date, we recommend a hybrid solution with a home-made multiport and use of an additional standard robotic trocar which allows the use endowrist® technology instruments.

Surrogate endpoints in early prostate cancer research.

Clinical research into clinically-localized prostate cancer (PC) is a highly challenging environment. The protracted durations and large numbers required to achieve survival endpoints have placed much pressure on validating early surrogate endpoints. Further confounding is the predominance of deaths from causes other than PC. The analysis of multiple randomized clinical trials in early PC has shown MFS to be a robust surrogate for OS, using a contemporary analytic framework that identify patient-level and trial-level associations. This could potentially save around one year of trial follow-up in some therapies. Identification of a similarly robust surrogate at a substantially earlier timepoint remains a major challenge. Multiple biochemical indices based on PSA have been proposed in the literature, but all remain to be validated at the trial-level. Operationally, many of these indices have inherent biases such as immortal-time bias (ITB) and interval censoring that potentially weakens associations and the individual- or trial-level. The complexity of a failure definition can also impact the reliability of the derived outcomes. Confounding issues such as the impact of comorbidities leading to non-cancer deaths have been largely dealt with by their exclusion using cancer-specific endpoints and advanced statistical methods, while issues such as PSA “bounce” and recovery from androgen deprivation therapy remain important to account for in cohorts treated with radiotherapy. Several potential surrogate endpoints based on serum prostate-specific antigen (PSA) levels show promising associations with PC-specific and overall survival (OS) in individual studies. Further large collaborative projects will continue to refine potential indices with these issues in mind, and explore the objective of an early surrogate of OS.

MP02-10 ARE UROLOGIC SURGEONS PERFORMING RADICAL PROSTATECTOMY IN THE CANADIAN UNIVERSAL HEALTH CARE SYSTEM PROVIDING HIGH QUALITY AND UNIFORM PROSTATE CANCER CONTROL?

You have accessJournal of UrologyGeneral & Epidemiological Trends & Socioeconomics: Quality Improvement & Patient Safety I1 Apr 2018MP02-10 ARE UROLOGIC SURGEONS PERFORMING RADICAL PROSTATECTOMY IN THE CANADIAN UNIVERSAL HEALTH CARE SYSTEM PROVIDING HIGH QUALITY AND UNIFORM PROSTATE CANCER CONTROL? Trevor Haines, Sunita Ghosh, Adrian Fairey, Niels Jacobsen, Benjamin Beech, Jan Rudzinski, Ryan Mclarty, Nick Dean, Steven Tong, and Dylan Hoare Trevor HainesTrevor Haines More articles by this author , Sunita GhoshSunita Ghosh More articles by this author , Adrian FaireyAdrian Fairey More articles by this author , Niels JacobsenNiels Jacobsen More articles by this author , Benjamin BeechBenjamin Beech More articles by this author , Jan RudzinskiJan Rudzinski More articles by this author , Ryan MclartyRyan Mclarty More articles by this author , Nick DeanNick Dean More articles by this author , Steven TongSteven Tong More articles by this author , and Dylan HoareDylan Hoare More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.136AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The 2010 Canadian Urological Association (CUA) consensus guideline examining surgical quality performance for radical prostatectomy states that urologic surgeons should achieve an unadjusted positive surgical margin (R1) rate < 25% for organ-confined (i.e., pT2) disease. To date, no study has examined whether Canadian urologic surgeons are achieving this benchmark. The primary objective of the current study was to determine the proportion of urologic surgeons achieving an unadjusted pT2-R1 rate < 25%. A secondary objective was to determine whether between-surgeon variation (i.e., heterogeneity) exists in pT2-R1 rates. METHODS A retrospective analysis of prospectively collected data from the University of Alberta (UA) Radical Prostatectomy Database was performed. Men who underwent radical prostatectomy for clinically localized prostate cancer (CLPC) between September 2007 and August 2017 by 1 of 9 urologic surgeons were analyzed. The primary outcome was pT2-R1 rate. General anatomic pathologists at 2 sites reviewed radical prostatectomy specimens. There was no centralized pathology review. A R1 was defined as the presence of cancer at the inked margin. Multivariable random effects models were used to evaluate heterogeneity in pT2-R1 rates after adjustment for case mix. Statistical tests were two-sided (p≤0.05). RESULTS Pathologic data were evaluable for 1870 patients. 1323 out of 1870 patients (71%) had pT2 disease. 6 out of 9 surgeons achieved unadjusted pT2-R1 rates < 25%. 3 surgeons had unadjusted pT2-R1 rates ≤ 15% whereas 3 surgeons had unadjusted pT2-R1 rates ≥ 28%. Multivariable random effects models showed statistically significant between-surgeon variation in pT2-R1 rates (p=0.024). CONCLUSIONS UA urologic surgeons are not all achieving the CUA pT2-R1 benchmark for surgical quality performance for radical prostatectomy. A patient′s likelihood of achieving optimal cancer control differs depending on which urologic surgeon performs his radical prostatectomy. Surgical quality performance initiatives designed to improve pT2-R1 rates of radical prostatectomy are warranted. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e15 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Trevor Haines More articles by this author Sunita Ghosh More articles by this author Adrian Fairey More articles by this author Niels Jacobsen More articles by this author Benjamin Beech More articles by this author Jan Rudzinski More articles by this author Ryan Mclarty More articles by this author Nick Dean More articles by this author Steven Tong More articles by this author Dylan Hoare More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

P027 - Comparative effectiveness of survival among surgery and radiotherapy for clinical localized prostate cancer

P027 - Comparative effectiveness of survival among surgery and radiotherapy for clinical localized prostate cancer

Long-term Oncologic Outcomes of Robotic-assisted Radical Prostatectomy by a Single Surgeon

The aim of the study was to evaluate the long-term oncology outcomes of prostate cancer patients receiving robotic-assisted radical prostatectomy (RARP). We retrospectively evaluated 111 patients with clinically-localized prostate cancer receiving RARP with a mean follow-up of 103.43 months. The 5-year BCRFS and 8-year BCRFS among low-, intermediate-, and high-risk patients were 95.5% vs. 77.1% vs. 53.7% and 95.5% vs. 61.2% vs. 48.1% (p=0.000). The median time to BCR in these three groups was 122.5, 98.0, and 79.2 months. Regarding postoperative factors, positive lymph node (HR=3.748, 95% CI=1.407-9.984), pathology Gleason score (HR=1.507, 95%CI=1.010-2.248), and postoperative nadir PSA <0.003 ng/ml (HR=0.058, 95%CI=0.020-0.166) were independent risk factors for BCR. D'Amico risk classification was effective at predicting biochemical recurrence in patients receiving RARP. Furthermore, postoperative risk factors such as metastatic lymph node, pathology Gleason score, and nadir PSA <0.003 ng/ml were independent predictors of biochemical recurrence.

Abstract 5324: ERG expression and PTEN loss by BMI and weight change in men with prostate cancer

Abstract Background: Obesity and weight gain are associated with poor prostate cancer outcome; underlying mechanisms are unknown. Obesity has been more strongly associated with lethal disease in men positive for the TMPRSS2:ERG gene fusion than negative for this fusion. PTEN loss is associated with increased risk of lethal progression; its association with obesity has not been explored. We evaluated whether prevalence of ERG expression and PTEN loss in prostate tumors differs by BMI and weight change. Methods: From a retrospective cohort study of 1,337 men with clinically-localized prostate cancer who underwent prostatectomy at Johns Hopkins (1993-2006), we sampled 291 men by combination of BMI at 1 year after surgery (normal, overweight, obese) and weight change from 5 years before to 1 year after surgery (loss, maintenance, gain). Within each category, men were frequency-matched on age, Gleason sum, organ confinement, and surgery year. We used genetically validated immunohistochemistry assays to assess ERG positivity and heterogeneous PTEN loss. Logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for the association of BMI and weight change (adjusted for height, starting weight) with ERG positivity and heterogeneous PTEN loss. Results: Mean age was 56.1 years and mean Gleason sum was 6.2; 73% had organ-confined disease. Prevalence of ERG positivity did not statistically significantly differ by BMI or weight change. However, when jointly categorized by BMI and weight change, overweight/obese men who maintained (OR=2.5; 95%CI 1.1-5.7) or gained weight (OR=2.5; 95%CI 1.1-5.8), and normal weight men who gained weight (OR=4.7; 95%CI 1.4-15.2) were significantly more likely to have ERG positive tumors compared with normal weight men who maintained weight. Overweight/obese men were also significantly more likely (OR=2.4; 95%CI 1.3-4.7) to have PTEN loss compared with normal weight men. When stratified by ERG status, this association appeared to be stronger for men with ERG positive tumors (OR=2.9; 95%CI 1.3-6.8) than for men with ERG negative tumors (OR=1.6; 95%CI 0.6-4.9). Prevalence of PTEN loss did not differ by weight change. When jointly categorized by BMI and weight change, overweight/obese men who maintained (OR=2.0; 95%CI 0.8-5.3) or gained weight (OR=1.9; 95%CI 0.7-5.1) appeared to be more likely to have PTEN loss compared with normal weight men who maintained weight. Conclusions: Overweight/obese men who maintained or gained weight circa diagnosis and normal weight men who gained weight were more likely to have ERG positive tumors. Overweight/obese men were more likely to have tumors with PTEN loss; this association was stronger among overweight/obese men who also had ERG positive tumors. The TMPRSS2:ERG gene fusion and PTEN loss may contribute to the increased risk of poor prostate cancer outcomes among overweight/obese men. Funding: Prostate Cancer Foundation Citation Format: Janelle S. Ho, Ibrahim Kulac, Tamara L. Lotan, John R. Barber, Patrick C. Walsh, Misop Han, Angelo M. De Marzo, Elizabeth A. Platz, Corinne E. Joshu. ERG expression and PTEN loss by BMI and weight change in men with prostate cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 5324. doi:10.1158/1538-7445.AM2017-5324

Background factors and short-term health-related quality of life in patients who initially underwent radical prostatectomy or androgen deprivation therapy for localized prostate cancer in a Japanese prospective observational study (J-CaP Innovative Study-1).

BackgroundThis prospective observational study elucidated the usefulness of hormonal therapy for localized prostate cancer. Background factors and the health-related quality of life in patients who initially underwent radical prostatectomy (RP) or primary androgen deprivation therapy (PADT) for localized prostate cancer are summarized.Materials and methodsPatients aged 67–76 years with clinical stage T1c or T2 localized prostate cancer treated with PADT or RP, a prostate-specific antigen concentration of <20 ng/mL, and Gleason score of ≤7 were included. Health-related quality of life results estimated by the Medical Outcomes Study 8-Item Short-Form Health Survey (SF-8) and the Expanded Prostate Cancer Index Composite (EPIC) were investigated.ResultsIn total, 850 patients who underwent RP and 370 patients who underwent PADT were enrolled. The proportion of patients with comorbidities of hypertension, cardiovascular disease, and/or cerebrovascular disease was greater in the PADT group than in the RP group. The proportion of patients deciding on treatment was significantly higher in the PADT group than in the RP group. In the RP group, the scores of many SF-8 and EPIC domains decreased at 3 months following surgery and returned to baseline levels at 1 year. In the PADT group, several domains gradually decreased during the year after treatment initiation. The proportion of patients with decreased satisfaction scores at 1 year compared with baseline was lower in the PADT group than that in the RP group.ConclusionTreatment risk influenced decisions on primary treatment for localized prostate cancer. Although there was a selection bias, short-term overall satisfaction in the PADT group was superior to that in the RP group in this clinical study.

MP64-10 IS THERE AN AGE LIMIT FOR THE INDICATION OF EXTENDED PELVIC LYMPH NODE DISSECTION DURING RADICAL PROSTATECTOMY IN PATIENTS WITH CLINICALLY LOCALIZED PROSTATE CANCER?

You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy V1 Apr 2017MP64-10 IS THERE AN AGE LIMIT FOR THE INDICATION OF EXTENDED PELVIC LYMPH NODE DISSECTION DURING RADICAL PROSTATECTOMY IN PATIENTS WITH CLINICALLY LOCALIZED PROSTATE CANCER? Alessandro Larcher, Nicola Fossati, Giorgio Gandaglia, Umberto Capitanio, Paolo Dell'Oglio, Emanuele Zaffuto, Nazareno Suardi, Marco Bandini, Shahrokh Shariat, Francesco Montorsi, and Alberto Briganti Alessandro LarcherAlessandro Larcher More articles by this author , Nicola FossatiNicola Fossati More articles by this author , Giorgio GandagliaGiorgio Gandaglia More articles by this author , Umberto CapitanioUmberto Capitanio More articles by this author , Paolo Dell'OglioPaolo Dell'Oglio More articles by this author , Emanuele ZaffutoEmanuele Zaffuto More articles by this author , Nazareno SuardiNazareno Suardi More articles by this author , Marco BandiniMarco Bandini More articles by this author , Shahrokh ShariatShahrokh Shariat More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , and Alberto BrigantiAlberto Briganti More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.1983AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Available recommendations for extended lymph node dissection [eLND] at radical prostatectomy [RP] do not consider patient age, but rely on cancer characteristics only. However, for patients with limited life-expectancy, eLND might be an overtreatment. We hypothesized that limited life-expectancy of older RP candidates might dilute any beneficial effect of eLND in terms of cancer staging and outcomes. Therefore, we aimed at assessing the differential effect of age on the risk of lymph node invasion [LNI] and mortality due to cause other than prostate cancer [OCM] in order to define an age limit above which eLND might be avoided. METHODS We included 3,906 patients diagnosed with prostate cancer and treated with RP and an anatomically defined eLND at a single Institution. Logistic and Cox regression analyses were used to compute the risk of LNI at eLND and the risk of OCM 10 years after RP. Predictors of LNI were chosen in compliance with guidelines-recommended models and were PSA, primary and secondary biopsy Gleason score and clinical stage. Predictors of OCM were age at surgery, Charlson comorbidity index [CCI] and year of surgery. Locally weighted scatterplot smoothing method was used to graphically examine the differential effect of age on the risk of LNI and OCM. RESULTS Median age was 65 years. LNI rate was 12%. 10-year OCM rate was 5%. PSA (odd ratio [OR] 1.06; p<0.001), primary (OR 5.32; p<0.001) and secondary (OR 2.27; p<0.001) biopsy Gleason score ≥4 as well as clinical stage cT2 (OR 2.4; p<0.001) and cT3 (OR 3.24; p<0.001) were associated with higher LNI risk. Age (hazard ratio [HR] 1.11; p<0.001) and CCI (HR 1.28; p=0.03) were associated with higher OCM risk. Year of surgery (HR 0.92; p<0.001) was associated with lower OCM risk. For patients aged 75 or younger, the risk of LNI (8-11%) was higher than the risk of OCM (<1-10%; Figure 1). Conversely, for patients aged 76 or older the risk of LNI (11-17%) was equal or lower than the risk of OCM (11-26%). CONCLUSIONS For RP candidates older than 75 years, the risk of OCM equals or exceeds the risk of LNI. Such relatively high risk of OCM compared to the relatively low risk of LNI casts relevant doubts on any potential benefit related to eLND at RP. These findings argue against the routine use of eLND for older patients in clinical practice. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e848 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Alessandro Larcher More articles by this author Nicola Fossati More articles by this author Giorgio Gandaglia More articles by this author Umberto Capitanio More articles by this author Paolo Dell'Oglio More articles by this author Emanuele Zaffuto More articles by this author Nazareno Suardi More articles by this author Marco Bandini More articles by this author Shahrokh Shariat More articles by this author Francesco Montorsi More articles by this author Alberto Briganti More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...