Radical Prostatectomy In Men Research Articles

Should all prostate needle biopsy Gleason score 4 + 4 = 8 prostate cancers be high risk? Implications for shared decision-making and patient counselling

ObjectivesTo estimate the probability of downgrading to Gleason score ≤7 at radical prostatectomy for men with a prostate needle biopsy demonstrating Gleason score 8 (4 + 4). MethodsThis is a retrospective review of men with Gleason score 8 (4 + 4) prostate cancer on needle biopsy who then underwent a radical prostatectomy at the Karmanos Cancer Institute or the University of Michigan. Men with any pattern 5 on the diagnostic biopsy were excluded. The objective was to estimate the proportion of patients whose tumors were downgraded to Gleason score ≤7 at radical prostatectomy and to identify clinical and biopsy parameters associated with downgrading. ResultsMedian age of our cohort was 63 years (IQR: 59, 67.5) and median follow-up was 15 months (IQR: 7, 37). Of the 105 men that met inclusion criteria, 59% (62/105) were downgraded to Gleason score ≤7 at radical prostatectomy. Having ≤2 cores demonstrating Gleason score 8, ≤50% maximal tumor involvement of any individual core positive for Gleason score 8, or the presence of Gleason pattern 3 (such as 3 + 4, 4 + 3, or 3 + 3) in other biopsy cores were all independently associated with downgrading in our multivariable model. Depending on the absence, presence, or combination of these 3 factors, patients had an estimated 6% to 82% probability of having their tumor downgraded at radical prostatectomy. ConclusionsMen with low volume Gleason 8 (4 + 4) and/or the presence Gleason pattern 3 on prostate needle biopsy often have their tumors downgraded at radical prostatectomy. The presence of these preoperative biopsy parameters could affect pretreatment counseling and impact patient management.

P021 - Analysis of surgical, oncological and functional outcomes of robot assisted radical prostatectomy in men over 75 years of age

P021 - Analysis of surgical, oncological and functional outcomes of robot assisted radical prostatectomy in men over 75 years of age

LBA48_PR - Adjuvant or salvage radiotherapy for the treatment of localised prostate cancer? A prospectively planned aggregate data meta-analysis

LBA48_PR - Adjuvant or salvage radiotherapy for the treatment of localised prostate cancer? A prospectively planned aggregate data meta-analysis

Advancing Age and the Odds of Upgrading and Upstaging at Radical Prostatectomy in Men with Gleason Score 6 Prostate Cancer

Advancing age is associated with upgrading/upstaging at radical prostatectomy (RP). We investigated how to identify healthy older men with Gleason score (GS) 6 prostate cancer (PC) who are at high risk for upgrading/upstaging who should be recommended for multiparametric magnetic resonance imaging (mpMRI). Between 1992 and 2017, 3571 men with GS6 PC were consecutively treated with RP at a single institution. Logistic regression multivariable analyses to determine the odds of upgrading and upstaging were performed adjusting for age at and year of diagnosis, clinical T category, prostate-specific antigen level, number of biopsy cores, and the percentage of positive biopsy cores (PPB). Of 3571 men, 115 (3.22%), 245 (6.86%) and 254 (7.11%) were upgraded, upstaged or had positive surgical margins (R1), respectively. Increasing age at diagnosis was associated with increased risk of upgrading to GS7 or higher, prostatectomy (p)T3/T4 and R1 with adjusted odds ratios of 1.05 (95% confidence interval (CI): 1.01-1.08, p=0.005), 1.02 (95% CI: 1.00-1.05, p=0.048) and 1.02 (95% CI: 1.002-1.05, p=0.03), respectively. Advancing age was associated with an increasing proportion of men upgraded to GS7 or higher (T1c: p = 0.002; T2 or higher: p = 0.04) or upstaged to pT3/4 or pT2R1(T1c: p = 0.02; T2 or higher: p = 0.02) among men with PPB >= but not <33%. Prior to initiating active surveillance, obtaining an mpMRI in otherwise healthy older men with GS6 PC and PPB >=33% should be considered.

Advancing Age and the Odds of Upgrading and Upstaging at Radical Prostatectomy in Men with Gleason Score 6 Prostate Cancer.

To identify a subset of men with Gleason score (GS) 6 prostate cancer who are at high risk for upgrading/upstaging who should be recommended for multiparametric magnetic resonance imaging. Between 1992 and 2017, a total of 3571 men with GS6 prostate cancer were consecutively treated at a single institution with radical prostatectomy. Logistic regression multivariable analyses to determine the odds of upgrading and upstaging were performed, adjusting for age and year of diagnosis, clinical T category, prostate-specific antigen level, number of biopsy cores, and percentage of positive biopsy cores. Of 3571 men, the disease of 115 (3.22%), 245 (6.86%), and 254 (7.11%) was upgraded, was upstaged, or had positive surgical margins (R1), respectively. Older age at diagnosis was associated with an increased risk of upgrading disease to GS7 or higher, prostatectomy T3/T4, and R1 with adjusted odds ratios (95% confidence intervals) of 1.05 (1.01-1.08; P= .005), 1.02 (1.00-1.05; P= .048), and 1.02 (1.002-1.05; P= .03), respectively. Older age was associated with an increasing proportion of men with disease upgraded to GS7 or higher (T1c: P= .002; T2 or higher: P= .04) or upstaged to pT3/4 or pT2R1 (T1c: P= .02; T2 or higher: P= .02) among men with≥ 33% but not< 33% positive biopsy cores. Before initiating active surveillance, performing multiparametric magnetic resonance imaging in otherwise healthy older men with GS6 prostate cancer and≥ 33% positive biopsy cores should be considered.

Management of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): an Evolving Treatment Paradigm.

Combination systemic therapy is now standard of care for all men with metastatic, hormone-sensitive prostate cancer (mHSPC). Patients with mHSPC should be treated with standard androgen deprivation therapy (ADT) and abiraterone acetate with prednisone or docetaxel (chemohormoanl therapy) unless there are contraindications to combination therapy. Based on the Chemohormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) study subgroup analysis, chemohormonal therapy may be most beneficial in men with high-volume disease burden, as men with low-volume metastatic disease do not appear to experience a survival benefit with chemohormonal therapy, while abiraterone in combination with ADT appears to be beneficial across both disease volume subgroups. Decisions regarding whether to use chemohormonal therapy or abiraterone and ADT for men with mHSPC should integrate consideration of volume of disease burden, quality of life effects, duration of therapy, and patient preferences for treatment as there is no formally powered prospective head-to-head comparison of these options demonstrating superiority of one approach over the other. Treatment of the primary tumor with radiation should be considered in men with de novo low-volume metastatic disease as radiation is associated with prolonged survival and a tolerable toxicity profile. Men with de novo high-volume metastatic disease do not appear to have improved survival with radiation of the primary tumor. Numerous clinical trials are ongoing to evaluate treatment approaches that may benefit men with mHSPC. Radical prostatectomy in men with mHSPC in combination with optimal systemic therapy is currently being assessed in a clinical trial, but should not be considered outside of a clinical trial. Metastasis-directed therapy with radiotherapy directed at metastatic lesions is still investigational, but can be considered in clinical trials in men with oligometastatic disease. Multiple studies are enrolling worldwide for men with mHSPC, and these should be considered for all interested patients.

PT390 - TRoMbone: Testing radical prostatectomy in men with oligo metastatic prostate cancer that has spread to the bone - a randomized controlled feasibility trial

PT390 - TRoMbone: Testing radical prostatectomy in men with oligo metastatic prostate cancer that has spread to the bone - a randomized controlled feasibility trial

Phase II trial enzalutamide and androgen deprivation therapy (ADT) with salvage radiation in men with high-risk PSA recurrent prostate cancer (PC): The STREAM trial.

29 Background: Salvage external beam radiotherapy (RT) and hormonal therapy improves survival over RT alone in men with non-metastatic hormone naïve PC and PSA recurrence after radical prostatectomy (RP). We investigated the safety/efficacy of enzalutamide with salvage RT and ADT in this setting. Methods: This was a 3 center prospective phase 2 single arm clinical trial in the Dept of Defense Prostate Cancer Clinical Trials Consortium. Eligibility: Gleason 7-10 PC and PSA recurrence within 4 years (yrs) of RP, PSA 0.2-4.0, no prior hormonal therapy, and no metastases on CT/Bone Scan imaging. Men received 6 months (mos) of ADT with 160 mg/d enzalutamide and 66 Gy RT to the prostate bed. Primary endpoint was 2 yr PFS with testosterone (T) recovery to &gt;100 ng/dl. Secondary objectives included PSA nadir, 3 yr PFS, safety and patient reported quality-of-life over time. This trial was designed with 84% power to detect a 20% improvement in 2 yr PFS vs historic data and a 1-sided alpha of 0.05. Results: We enrolled 38 men (90% white, 8% black, 2% Asian); 37 (97%) completed therapy and were evaluable with T recovery at 2 yrs. Median age was 64 yrs; 47% Gleason 8-10, 79% T3/T4 disease, 21% had resected N+ PC; median PSA was 0.4 (0.19-4.19). Median follow-up is 29.5 mo. Treatment was well tolerated with 11 patients (29%) experiencing G3 toxicities (including 4 HTN, 2 urinary retention, 2 CV events); no G4-5 or unexpected toxicities were observed. T recovery occurred in 35 (95%) at 12 mos. The primary endpoint of 2 yr PFS was 65% (95% CI: 47%-78% vs. historic controls with 51% 2 yr PFS rate) among the 37 patients with T recovery. PSA remained at undetectable levels in 69% at 2 yrs. The 3 yr PFS was 53% (95% CI: 36%, 68%). QOL data over time suggest short term reductions in urinary and sexual function with recovery by 12-24 mo in most men. Conclusions: Salvage enzalutamide and ADT for 6 months with RT following RP for men with PSA recurrent high risk PC is safe, and demonstrates encouraging efficacy at 2 and 3 years. Most men have testosterone recovery at 1 year. These data warrant prospective controlled phase 3 trials to assess the impact of potent AR inhibition in this curative intent setting. Clinical trial information: NCT02057939.

Age and aggressiveness of prostate cancer: analysis of clinical and pathological characteristics after radical prostatectomy for men with localized prostate cancer.

IntroductionThe aim of this study was to describe age- related prostate cancer (PCa) characteristics in men after radical prostatectomy (RP).Material and methodsThere were 2,373 men who underwent RP for clinically localized PCa between 2002 and 2017 and had complete data that were included into the study. Among them, 315 (13.3%) men aged ≤55 years (GR-1), 1,098 (46.3%) men aged between 56 to 65 years (GR-2) and 960 (40.4%) men aged older than 65 years (GR-3) were identified. All preoperative and pathological parameters were compared between all three groups and between each group separately. High-risk prostate cancer (HRPCa) cases were analyzed separately. Regression analysis was used to evaluate the impact of age on cancer aggressiveness.ResultClinical stage (cT), biopsy Gleason score and D'Amico risk groups were different comparing age-related study groups (all p <0.01), respectively. Preoperatively cT1 and Gleason 6 were in the highest rate for GR-1 in comparison with GR-3: 35.9 vs. 27.1%, p = 0.003 and 65.1% vs. 56.7%, p = 0.008, respectively. Analyzing pathological parameters, only Gleason 9–10 was different between GR-1 and GR-3–3.8 vs. 7.6%, p = 0.02. There were 921 (38.8%) HRPCa cases identified. Age was a significant predictor for HRPCa (p = 0.019) in the regression analysis. The oldest men (GR-3) had up to 1.5 fold increased risk for HRPCa detection in comparison with the youngest one (p = 0.008, HR1.44. 95% CI 1.098–1.87).ConclusionsYounger, ≤55-year-old men, are more likely to present with less aggressive clinical and pathological PCa features in comparison with the older ones. Increasing age has a significant influence on HRPCa detection after RP.

Results of Phase 1 study on cytoreductive radical prostatectomy in men with newly diagnosed metastatic prostate cancer

BackgroundPreclinical and retrospective data suggest that cytoreductive radical prostatectomy may benefit a subset of men who present with metastatic prostate cancer (mPCa). Herein, we report the results of the first planned Phase 1 study on cytoreductive surgery.MethodsFrom four institutions, 36 patients consented to the study. However, four did not complete surgery because of rapid disease progression (n = 3) and another because of an intraoperatively discovered pericolonic abscess. Men with newly diagnosed clinical mPCa to lymph nodes or bones were eligible. The primary endpoint was the rate of major perioperative complications (Clavien-Dindo Grade 3 or higher) occurring within 90 days of surgery.ResultsThe mean age at surgery was 64.0 years. The 90-day overall complication rate was 31.2% (n = 10), of which two (6.25%) were considered major complications: one acute tubular necrosis requiring temporary dialysis and one death. In men with more than 6 months of follow-up, 67.9% had prostate specific antigen nadir ≤0.2 ng/mL, while one patient experienced a rapid rise in prostate specific antigen and another a widely disseminated disease that resulted in death 5 months after surgery. Altogether, these results demonstrate that cytoreductive radical prostatectomy is safe and surgically feasible in selected patients who present with mPCa . Yet, there may be a small subset of patients in whom surgery may cause a significant harm.ConclusionTherefore, cytoreductive surgery in men with mPCa should be limited to clinical trials until robust data are available.

P273 - mpMRI for the prediction of unfavorable pathological features at radical prostatectomy in men initially managed with active surveillance for low risk PCA

P273 - mpMRI for the prediction of unfavorable pathological features at radical prostatectomy in men initially managed with active surveillance for low risk PCA

P269 - Multi-institutional external validation of the EAU guidelines recommendations for the use of staging mpMRI prior to radical prostatectomy in men with intermediate and high-risk prostate cancer

P269 - Multi-institutional external validation of the EAU guidelines recommendations for the use of staging mpMRI prior to radical prostatectomy in men with intermediate and high-risk prostate cancer

This Month in Adult Urology

No AccessJournal of UrologyThis Month in Adult Urology1 Oct 2018This Month in Adult Urology Joseph A. Smith Joseph A. SmithJoseph A. Smith More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.06.034AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail "This Month in Adult Urology." The Journal of Urology, 200(4), pp. 669–670 References 1 : Sexual function in a nationwide cohort of 2,260 survivors of testicular cancer after 17 years of followup. J Urol2018; 200: 794. Link, Google Scholar 2 : A national contemporary analysis of perioperative outcomes of open versus minimally invasive sacrocolpopexy. J Urol2018; 200: 862. Link, Google Scholar 3 : Is routine renal tumor biopsy associated with lower rates of benign histology following nephrectomy for small renal masses?. J Urol2018; 200: 731. Link, Google Scholar 4 : Bladder cancer survival of men receiving 5α-reductase inhibitors. J Urol2018; 200: 743. Link, Google Scholar 5 : Prostate specific antigen density as a predictor of clinically significant prostate cancer when the prostate specific antigen is in the diagnostic gray zone: defining the optimum cutoff point stratified by race and body mass index. J Urol2018; 200: 758. Link, Google Scholar 6 : Validation of Prostate Imaging Reporting and Data System version 2 for the detection of prostate cancer. J Urol2018; 200: 767. Link, Google Scholar 7 : Multi-institutional outcomes of endoscopic management of stricture recurrence after bulbar urethroplasty. J Urol2018; 200: 837. Link, Google Scholar 8 : Acupuncture for chronic prostatitis/chronic pelvic pain syndrome: a randomized, sham acupuncture controlled trial. J Urol2018; 200: 815. Link, Google Scholar 9 : Long-term outcomes after deferred radical prostatectomy in men initially treated with active surveillance. J Urol2018; 200: 779. Link, Google Scholar 10 : Menopause and risk of kidney stones. J Urol2018; 200: 823. Link, Google Scholar © 2018 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 200Issue 4October 2018Page: 669-670 Advertisement Copyright & Permissions© 2018 by American Urological Association Education and Research, Inc.MetricsAuthor Information Joseph A. Smith More articles by this author Expand All Advertisement PDF downloadLoading ...

Long-Term Outcomes after Deferred Radical Prostatectomy in Men Initially Treated with Active Surveillance

We sought to determine long-term outcomes after deferred radical prostatectomy. The study population consisted of all 132 men with screening detected prostate cancer who underwent deferred radical prostatectomy from January 1, 1995 to December 31, 2014 after active surveillance in the Göteborg Randomized, Population-based Prostate Cancer Screening Trial. The last date of followup was May 15, 2017. Followup during active surveillance was performed with prostate specific antigen tests every 3 to 6 months and repeat biopsies every 2 to 4 years. Triggers for radical prostatectomy were disease progression based on prostate specific antigen, grade and/or stage, or patient request. Outcomes included adverse pathology findings at radical prostatectomy, defined as Gleason score greater than 3 + 4, extraprostatic extension, positive margins, seminal vesicle invasion and/or N+, whether the index tumor at radical prostatectomy was identified at biopsy and prostate specific antigen relapse-free survival. Kaplan-Meier analysis was performed. Median time from diagnosis to surgery was 1.9 years (IQR 1.2-4.2) and median postoperative followup was 10.9 years (IQR 7.5-14.5). A total of 52 men (39%) experienced at least 1 unfavorable pathology feature at radical prostatectomy. The 10-year prostate specific antigen relapse-free survival was 79.5%. The index tumor was not identified in the diagnostic biopsy in 38 of the 132 men (29%) or at the last repeat biopsy that preceded radical prostatectomy 22 of 105 (21%). A large proportion of men had unfavorable pathology findings at deferred radical prostatectomy and the index tumor was frequently not identified. There is a clear need for better risk classification and protocols to determine disease progression during active surveillance.

Cytoreductive Radical Prostatectomy in Men with Prostate Cancer and Skeletal Metastases

BackgroundAndrogen deprivation therapy (ADT) represents the standard treatment for hormone-naïve prostate cancer with systemic metastases (mPCA). The role of radical prostatectomy (RP) in this setting is unclear. ObjectiveTo evaluate the oncological and functional outcomes of men with mPCA who underwent cytoreductive RP (CRP). Design, setting, and participantsRetrospective, multi-institutional study of 113 patients with biopsy-proven mPCA who fulfilled the following selection criteria: (1) completely resectable PCA; (2) osseous metastases; (3) absence of gross retroperitoneal lymph node metastases; (4) absence of bulky pelvic lymph node metastases >3cm; (5) no or minimal visceral metastases; (6) Eastern Cooperative Oncology Group performance status of 0–1; and (7) written informed consent. InterventionCRP with extended pelvic lymphadenectomy. Eighty patients (70.8%) received neoadjuvant ADT and 91 (86.5%) adjuvant ADT and/or radiation therapy. Outcome measurements and statistical analysisCancer-specific survival, overall survival (OS), biochemical relapse-free survival (BRFS), and clinical relapse-free survival (CRFS) were evaluated using descriptive statistical analyses, the Kaplan-Meier method, and univariate and multivariate analyses. Treatment-associated complications were analysed according to the Clavien-Dindo classification. Results and limitationsThe mean patient age was 61 yr (range 42–69). The mean follow-up was 53.6 mo (range 13–96, median 45.7). The 3-yr and 5-yr OS was 99 (87.6%) and 90 (79.6%), respectively, and the mean CRFS was 72.3 mo. Preoperative prostate-specific antigen (PSA)<1.0ng/ml and PSA below the median of 8.0ng/ml were significantly associated with BRFS (p<0.0004). Pathohistology revealed viable PCA in all cases: 16 (14.2%) had pT4a, 21 (18.6%) had pT2a–c, and 76 (67.3%) had pT3a/b PCA. Positive lymph nodes were identified in 61.6% and positive surgical margins in 36.8% of the patients. Eleven men (9.7%) experienced Clavien Dindo grade IIIa–b complications. Low-volume disease, neoadjuvant ADT, and preoperative PSA were significantly associated with a lower risk of surgery-related complications (p<0.05). No, mild (1–2 pads/d), and severe incontinence (>2 pads/d) was observed in 68.1%, 17.7%, and 14.1%, respectively. Limitations of the study are the retrospective nature and potential patient selection bias. ConclusionsCRP results in 5-yr OS of 80%, a low rate of significant complications, and good functional outcome in well-selected patients. CRP might be an individualised treatment option in the multimodal management of mPCA. Patient summaryWe assessed oncological and functional outcomes associated with cytoreductive radical prostatectomy (CRP) in select men with prostate cancer and osseous metastases. We found that CRP might be associated with long overall and relapse-free survival in well-selected patients. CRP could become an additional treatment option in the multimodal therapy of metastatic prostate cancer; it should be performed in a clinical protocol setting and does not represent a standard therapeutic option.

MP05-11 PATHOLOGICAL AND ONCOLOGICAL OUTCOMES IN PATIENTS WITH PSA≥10 NG/ML LOW RISK PROSTATE CANCER

You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy I1 Apr 2018MP05-11 PATHOLOGICAL AND ONCOLOGICAL OUTCOMES IN PATIENTS WITH PSA≥10 NG/ML LOW RISK PROSTATE CANCER Cristina Negrean, Mila Mansour, Félix Couture, Kevin C. Zorn, Marc Zanaty, Pierre Karakiewicz, Côme Tholomier, Naeem Bhojani, and Azizi Mounsif Cristina NegreanCristina Negrean More articles by this author , Mila MansourMila Mansour More articles by this author , Félix CoutureFélix Couture More articles by this author , Kevin C. ZornKevin C. Zorn More articles by this author , Marc ZanatyMarc Zanaty More articles by this author , Pierre KarakiewiczPierre Karakiewicz More articles by this author , Côme TholomierCôme Tholomier More articles by this author , Naeem BhojaniNaeem Bhojani More articles by this author , and Azizi MounsifAzizi Mounsif More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.182AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Low risk prostate cancers (PCa) represent a particular challenge for physicians. Which patients should be on active surveillance (AS) and which should receive a more aggressive treatment including radical prostatectomy (RP)? Up to date, very few data is available on the differences in prognosis between PSA<10 ng/mL and PSA≥10 ng/mL in men with low risk prostate cancer after RP. Herein, we sought to compare onco-pathological outcomes in men with PSA<10 ng/mL vs PSA≥10 ng/mL after robotic assisted radical prostatectomy (RARP). We hypothesised that biochemical recurrence (BCR) rate would be lower in PSA<10 ng/mL. As a secondary endpoint, we tried to assess outcomes in men with PSA≥10 ng/mL on AS versus those who were upfront not on AS to assess any oncological differences between groups. METHODS We conducted a retrospective study on the prospectively maintained database. 309 patients with low risk Gleason 6 prostate cancer who had RARP at university hospital (CHUM) between 2007 and 2017 were included in this study. They were divided in 2 groups based on serum PSA; group 1 with PSA<10 ng/mL (n=279) and group 2 with PSA≥10 ng/mL (n=30). Using Kaplan-Meier curves BCR-free period was compared between the two groups. Furthermore, we examined at oncological outcomes in PSA≥10 ng/mL group between men on AS and those not on AS using t-test. RESULTS With regards to Gleason upgrading after RARP, no significant difference was observed between the 2 groups (57.3%, 66.7%, p=0.370). However, with a median follow up of 36 months, BCR was significantly higher in PSA≥10 ng/mL, 16.7% compared to 1.8% in PSA<10 ng/mL (p<0.001). The mean BCR-freedom was 70.7 ± 0.6 months in the last group. This was statistically longer than for PSA≥10 ng/mL group (61.0 ± 4.5 months, p<0.001). The BCR inside the PSA≥10 ng/mL group was similar between AS and non-AS subgroups (0% versus 23.8% respectively, p value = 0.109). CONCLUSIONS Our results advocate that patients with Gleason 6 low risk PCa and PSA≥10 ng/mL have greater BCR rate as opposed to PSA<10 ng/mL. The BCR-freedom is statistically shorter for patients with PSA higher than 10 ng/mL. This supports that PSA value is an independent indicator for BCR after radical prostatectomy in men with low risk cancer. Moreover, among men with PSA≥10 ng/mL, oncological outcomes appear to be similar regardless of the management approach, AS or not. This might suggest that low risk PCa with PSA≥10 can be managed by AS after RP without increasing their risk of BCR. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e46-e47 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Cristina Negrean More articles by this author Mila Mansour More articles by this author Félix Couture More articles by this author Kevin C. Zorn More articles by this author Marc Zanaty More articles by this author Pierre Karakiewicz More articles by this author Côme Tholomier More articles by this author Naeem Bhojani More articles by this author Azizi Mounsif More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

PD20-06 THE IMPACT OF MULTIPARAMETRIC MRI ON PREDICTING PROGRESSION IN MEN ON ACTIVE SURVEILLANCE FOR PROSTATE CANCER

You have accessJournal of UrologyProstate Cancer: Localized: Active Surveillance III1 Apr 2018PD20-06 THE IMPACT OF MULTIPARAMETRIC MRI ON PREDICTING PROGRESSION IN MEN ON ACTIVE SURVEILLANCE FOR PROSTATE CANCER Zachary Kornberg, Antonio Carlos Westphalen, Janet E Cowan, June M Chan, Matthew R Cooperberg, Katsuto Shinohara, and Peter R Carroll Zachary KornbergZachary Kornberg More articles by this author , Antonio Carlos WestphalenAntonio Carlos Westphalen More articles by this author , Janet E CowanJanet E Cowan More articles by this author , June M ChanJune M Chan More articles by this author , Matthew R CooperbergMatthew R Cooperberg More articles by this author , Katsuto ShinoharaKatsuto Shinohara More articles by this author , and Peter R CarrollPeter R Carroll More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.1010AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Multiparametric MRI (mpMRI) and PI-RADS scoring are increasingly utilized to identify lesions suspicious for prostate cancer that may require intervention. We sought to determine whether PI-RADS score was associated with risk of disease progression in men on active surveillance (AS) who underwent re-biopsy and/or delayed radical prostatectomy (RP). METHODS UCSF participants were enrolled on AS with low/intermediate risk prostate cancer (stage cT1/T2, CAPRA ≤5), had <33% positive cores and a Gleason score (GS) of 3+3 or 3+4 at diagnostic or confirmatory biopsy within 1 year, and underwent MRI. Primary outcomes were upgrade and progression on re-biopsy. Upgrade was defined as an increase from GS 3+3 to ≥3+4 or from GS 3+4 to ≥4+3. Progression was defined as upgrade or increase to >33% biopsy cores. The secondary outcome was adverse pathology on RP, defined as GS ≥4+3, stage ≥pT3a, or pN1 in a sub-group of men who underwent delayed surgery. We performed Cox proportional hazards regression models to evaluate association between PI-RADS score with each outcome, adjusted for diagnostic age (years), PSA (ng/ml), PSA density (log), and percent positive biopsy cores. RESULTS Of 1,585 men enrolled on AS, we evaluated 453 men with GS 3+3 (88%) and 3+4 (12%) who underwent MRI. Among patients with GS 3+3, PI-RADS 5 vs. PI-RADS 1-2 was associated with an increased risk of biopsy upgrade (Hazard Ratio [HR]: 2.93; 95% confidence interval [CI], 1.61-5.32, p<0.01, 159 events) and biopsy progression (HR: 2.28; CI, 1.40-3.71; p<0.01, 217 events) on re-biopsy. PI-RADS 4 vs. PI-RADS 1-2 was borderline associated with biopsy upgrade (HR: 1.79; CI 1.01-3.19; p=0.05), and associated with increased risk of biopsy progression (HR: 1.71; CI 1.08-2.72; p=0.02). PI-RADS 3 vs. PI-RADS 1-2 was associated with increased risk of biopsy upgrade (HR: 2.12; CI 1.17-3.83; p=0.01) and progression (HR: 1.68; CI 1.04-2.74; p=0.04). In a subgroup of 114 men who underwent delayed RP, PI-RADS score was not associated with increased risk of adverse pathology on delayed RP in men with GS 3+3, nor was PI-RADS associated with biopsy upgrade, progression, or adverse pathology in men with GS 3+4. CONCLUSIONS In patients with GS 3+3, PI-RADS 5 is associated with biopsy upgrade and progression, and PI-RADS 1-2 with non-progression. mpMRI may be a viable adjunct in treatment decision making for men on AS. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e403-e404 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Zachary Kornberg More articles by this author Antonio Carlos Westphalen More articles by this author Janet E Cowan More articles by this author June M Chan More articles by this author Matthew R Cooperberg More articles by this author Katsuto Shinohara More articles by this author Peter R Carroll More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

A 17-Gene Genomic Prostate Score Assay Provides Independent Information on Adverse Pathology in the Setting of Combined Multiparametric Magnetic Resonance Imaging Fusion Targeted and Systematic Prostate Biopsy

Multiparametric magnetic resonance imaging and biopsy based molecular tests such as the 17-gene Oncotype DX® Genomic Prostate Score™ assay are increasingly performed to improve risk stratification in men with clinically localized prostate cancer. The prostate score assay was previously shown to be a significant independent predictor of adverse pathology findings at radical prostatectomy in men diagnosed by systematic biopsies only. Therefore, we investigated the ability of the prostate score assay to predict adverse pathology findings in the setting of magnetic resonance imaging guided prostate biopsy. We identified men diagnosed with NCCN® (National Comprehensive Cancer Network®) very low, low or intermediate risk prostate cancer who underwent simultaneous multiparametric magnetic resonance imaging fusion targeted and systematic prostate biopsy with subsequent radical prostatectomy within 6 months. Prostate score assay testing was performed on biopsy tissue with the highest Gleason score. The primary outcome of the study was adverse pathology findings, defined as Gleason score 4 + 3 or greater disease and/or pT3+ at radical prostatectomy. Independent predictors of adverse pathology findings were determined in a multivariable model to adjust for clinical parameters. A total of 134 men were eligible for primary analysis. On univariable analysis the UCLA score, magnetic resonance imaging, prostate score assay results and biopsy Gleason score were significant predictors of adverse pathology findings. After multivariable adjustment prostate score assay values remained a significant predictor of adverse pathology results (prostate score assay per 20 U OR 3.28, 95% CI 1.74-6.62, p <0.001). A wide and overlapping distribution of prostate score assay results was seen across PI-RADS® (Prostate Imaging Reporting and Data System) version 2 scores. The prostate score assay result is an independent predictor of adverse pathology findings in patients who were diagnosed with very low, low or intermediate risk prostate cancer in the setting of multiparametric magnetic resonance imaging fusion prostate biopsy. This assay can be useful as an independent technology or an adjunct technology to multiparametric magnetic resonance imaging to individualize risk stratification of low and intermediate risk prostate cancer.

Results of a phase II trial of neoadjuvant abiraterone + prednisone+ enzalutamide + leuprolide (APEL) versus enzalutamide + leuprolide (EL) for patients with high-risk localized prostate cancer (PC) undergoing radical prostatectomy (RP).

79 Background: Patients with high-risk PC have an increased risk of recurrence and mortality despite therapy. Abiraterone, a CYP17 inhibitor, and enzalutamide, a next generation anti-androgen, have demonstrated improved overall survival in metastatic PC. In this multicenter randomized phase II trial, we evaluate the impact of second generation hormone therapy on RP pathologic outcomes. Methods: Eligible patients had biopsy Gleason score ≥4+3=7, PSA &gt;20 ng/mL or cT3 disease (by prostate MRI). Lymph node were require to be &lt;20 mm. Patients were randomized 2:1 to APE:EL for 6 cycles (24 weeks) followed by RP. All RPs underwent central pathology review. The primary endpoint was the rate of pathologic complete response (pCR) or minimum residual disease (MRD, tumor ≤5 mm). Secondary endpoints include PSA response, surgical staging at RP, positive margin rate, and safety. Results: 75 patients were enrolled at four sites: DFCI/BWH (n=55), BIDMC (n=11), UW (n=5), JHU (n=4). Median age was 62 years. Most patients had NCCN high-risk disease [n=66, 88%; cT3 n=21 (28%), Gleason 8-10 n=59 (79%), PSA &gt;20 ng/mL n=17 (23%)]. All patients completed 6 cycles followed by RP. Median PSA nadir was 0.03 and 0.02 ng/mL and time to nadir was 3.7 and 4.6 months in the APEL and EL arms, respectively. The combined pCR or MRD rate was 30% (n=15/50) in the APEL arm and 16% (n=4/25) in the EL arm. The response difference was 14% (80% CI -3%-30%, p=0.263). 15 patients (14 in APEL; 1 in EL) had grade 3 adverse events (AEs). The most common grade 3 AEs were hypertension (n=7) and ALT increase (n=5). No grade 4-5 AEs occurred. Conclusions: Neoadjuvant hormone therapy plus RP in men with high-risk PC resulted in favorable pathologic responses (≤5 mm residual tumor) in 16-30% with a trend towards improved pathologic outcomes with APEL and acceptable safety profile. Follow-up is necessary to evaluate the impact of therapy on recurrence rates. Clinical trial information: NCT02268175. [Table: see text]

The impact of race on adverse pathologic features at the time of radical prostatectomy in men with prostate cancer and implications for adjuvant radiotherapy.

75 Background: Patients with adverse pathologic features (≥pT3 disease or positive margins) at the time of radical prostatectomy (RP) have higher biochemical recurrence (BR). Adjuvant radiotherapy (ART) reduces BR, but has potential toxicities. Also, studies suggest Black men are more likely to have aggressive prostate cancer. Our objective was to identify whether black men undergoing RP are more likely to have adverse pathologic features (APF) that lead to an indication for ART. Methods: We conducted a retrospective cohort study of men with cT1-4 Nx/0 Mx/0 prostate adenocarcinoma in the National Cancer Database who underwent RP. Race was divided into 3 groups (Caucasian, Black, Other). Chi-square tests and analysis of variance (ANOVA) tests were used to compare clinical and socioeconomic covariates between race groups. Univariate (UVA) and multivariable analysis (MVA) were performed using logistic regression (LR) to identify covariates predicting for APF. LR was performed to identify the impact of race on pT3 disease and positive margins. Results: A total of 313,013 patients diagnosed between 2004-2014 and undergoing RP were included. 256,315 (85%) were Caucasian, 33,725 (11%) were Black, and 12,973 (4%) were Other race. Fewer Black men had Gleason group 1 (33% vs. 41%) but more had Gleason group 2 disease (46% vs. 38%, p &lt; 0.001). Black men more frequently had PSA ≥10 ng/ml (18% vs. 16%, p &lt; 0.001) and ≥cT2b disease (18% vs. 14%, p &lt; 0.001). On UVA, Black men were more likely to have APF (Odds Ratio [OR] 1.18; 95% Confidence Interval [CI] 1.15-1.21; [p &lt; 0.001]). On MVA, black race was independently associated with having APF (OR 1.21; 95% CI 1.18-1.24; p &lt; 0.001). Black men were more likely to have positive margins (OR 1.26; 95% CI 1.22-1.29; p &lt; 0.001) but less likely to have ≥pT3 disease (OR 0.77; 95% CI 0.74-0.79; p &lt; 0.001). Conclusions: Independent of socioeconomic and clinical factors, Black men undergoing RP are more likely to have APF, increasing the risk of BR in this group, and more frequently creating an indication for ART. This appears to be more due to positive margins than locally advanced tumor. The underlying cause of this disparity warrants further exploration.