Low-risk Prostate Cancer Patients Research Articles

Low serum total testosterone level as a predictor of upgrading in low-risk prostate cancer patients after radical prostatectomy: A systematic review and meta-analysis.

PurposeTo investigated the association between serum total testosterone and Gleason score upgrading of low-risk prostate cancer after radical prostatectomy (RP).Materials and MethodsMedline, Web of Science, Embase, and Cochrane Library databases were searched to identify eligible studies published before October 2021. Multivariate adjusted odds ratios (ORs) and associated 95% confidence intervals (CIs) were calculated using random or fixed effects models.ResultsFive studies comprising 1,203 low-risk prostate cancer patients were included. The results showed that low serum total testosterone (<300 ng/dL) is associated with a high rate of Gleason score upgrading after RP (OR, 2.3; 95% CI, 1.38–3.83; p<0.001; I2, 92.2%). Notably, sensitivity and meta-regression analyses further strengthen the reliability of our results.ConclusionsOur results support the idea that low serum total testosterone is associated with a high rate of Gleason score upgrading in prostate cancer patients after RP. It is beneficial for urologist to ensure close monitoring of prostate-specific antigen levels and imaging examination when choosing non-RP treatment for low-risk prostate cancer patients.

Utilization of IMRT and Brachytherapy for Low-Risk and Intermediate-Risk Prostate Cancer Patients: Analysis of the RealWorld Scenario

Purpose: Two main techniques in radiation therapy (RT) for the treatment of low-risk and intermediate-risk prostate cancer (PCa) are intensity-modulated radiation therapy (IMRT) and brachytherapy (BT). In this study, the pattern of utilization of IMRT, low dose-rate (LDR) BT, and high dose-rate (HDR) BT has been evaluated using a large hospital based registry database. Methods: We analyzed a very large data set of N0, M0, non-surgical, stage T1-T2c prostate cancer patients diagnosed between 2004 and 2015 from the National Cancer Database (NCDB). Based on the RT techniques used, we considered three groups of patients: (1) IMRT (n=61,159; 48.4%) who received an initial as well as a boost treatment with the IMRT, (2) BT LDR (n=43,293; 34.3%), and (3) BT HDR (n=21,938; 17.3%). A total dose of 70-81Gy for IMRT was considered. For brachytherapy, LDR and HDR or unspecified brachytherapy was considered as monotherapy. Patients were stratified according to the National Comprehensive Cancer Network (NCCN) guidelines into: low-risk [clinical stage T1-T2a, Gleason Score (GS) of ≤ 6 (Grade Group 1), and Prostate-specific antigen (PSA) of &lt; 10 ng/mL] and intermediate-risk [clinical stage T2b-T2c, GS of 7 (Grade Groups 2 and 3), and PSA of 10-20 ng/mL]. OS probability was determined using the Kaplan-Meier estimator. Propensityscore matched (PSM) analysis was performed for each risk group (low and intermediate) for the three research treatment modalities (IMRT, BT LDR, and BT HDR). IBM SPSS software was used for statistical analysis; p-value &lt;0.05 was considered statistically significant. Results: There has been a relative increase in IMRT usage for the treatment of both low-risk (29% to 53%) and intermediaterisk (53% to 77%) PCa patients from 2004 to 2015. Observed comparable median OS in low-risk and intermediate-risk patients in these three modalities IMRT (74.8/63.4 mo.), LDR (77.7/65.7 mo.) and HDR (83.5/72.1 mo.). Conclusion: The pattern of utilization of RT modality seems inclined toward increased use of IMRT over brachytherapy (59% vs. 41%) for both the low-risk and intermediate-risk PCa patients. Over the years, use of IMRT increased more in low-risk patient group than in intermediate-risk group.

Diagnostic Imaging in Low-Risk Prostate Cancer: More Harm Than Good?

Despite guidelines recommending that staging imaging is not needed in very low-risk (VLR) and low-risk (LR) prostate cancer (PCa), there is concern for overutilization in these risk groups. We investigate utilization of staging imaging and implications of findings in newly diagnosed VLR and LR PCa patients. A total of 493 patients diagnosed with PCa between 2011 and 2017 were stratified according to American Urological Association and National Comprehensive Cancer Network® VLR and LR groups. Computerized tomography (CT), magnetic resonance imaging and bone scan performed at diagnosis was captured and guidelines compliance was evaluated. The significance of radiologist interpreted imaging findings, by imaging type, were classified as normal, nonurological, nonsignificant urological and PCa significant. Greater than 75% of patients in the VLR and LR groups underwent imaging at time of diagnosis. Bone scan was performed in 30% of patients, none of which noted PCa-significant findings, and the majority were normal. CT was utilized in 38% of patients, with only 3 showing PCa-significant findings. Ten CTs showed nonurological/nonsignificant urological findings causing further evaluation. Magnetic resonance imaging was the most utilized scan in low-risk groups, occurring in 70% of patients. Although the majority were normal, 25 scans showed nonsignificant urological findings while only 7 showed PCa-significant findings. Among VLR and LR PCa patients, there is high overutilization of imaging with most studies yielding minimal PCa-significant findings and further evaluation for incidental observations. This exploratory analysis gives awareness that staging imaging in VLR and LR PCa patients may do more harm than good.

A randomized controlled trial evaluating the effect of low-dose chlormadinone in patients with low-risk prostate cancer: PROSAS study.

ObjectivesThis study was conducted to evaluate the effect of low-dose chlormadinone acetate, an antiandrogen agent, on the persistence rate of active surveillance in patients with low-risk prostate cancer.MethodsThe study was a multicenter, placebo-controlled, double-blind, randomized controlled trial conducted at 38 sites in Japan. Low-risk prostate cancer patients were randomly assigned to the chlormadinone group or the placebo group and the persistence rate of active surveillance was evaluated for 3 years.ResultsSeventy-one patients in the chlormadinone group and 72 patients in the placebo group were analyzed. The persistence rate of active surveillance [95% CI] at 3 years was 75.5% [62.5–84.6] in the chlormadinone group and 50.1% [36.7–62.2] in the placebo group, showing a significant difference between the groups (P = 0.0039). The hazard ratio [95% CI] of the chlormadinone group to the placebo group for discontinuation of active surveillance was 0.417 [0.226–0.770]. The chlormadinone group showed a significant decrease in prostate specific antigen level, testosterone level and prostate volume. The number of positive cores at 12 and 36 months biopsy was significantly lower in the chlormadinone group. The incidence of adverse events was 43.7% in the chlormadinone group and 12.5% in the placebo group. The most common adverse event in the chlormadinone group was constipation in 22.5%, followed by hepatobiliary disorders in 9.9%.ConclusionsIn patients with low-risk prostate cancer, low-dose chlormadinone showed a reduced number of positive cores and prostate volume, and an increased persistence rate of active surveillance (UMIN000012284).

Updated Toxicity and Quality-of-Life Outcomes From a Randomized Phase III Trial of Extreme Hypofractionated vs. Standard Fractionated Proton Therapy for Low-Risk Prostate Cancer

<h3>Purpose/Objective(s)</h3> We present an interim analysis of toxicity and quality-of-life (QOL) from a randomized phase III trial of extreme hypofractionated versus standard hypofractionated proton therapy for low-risk prostate cancer. <h3>Materials/Methods</h3> From 2011-2020, low-risk prostate cancer patients were randomized in a 1:2 fashion to standard fractionation (79.2 Gy [RBE] in 44 fractions, Arm A) versus extreme hypofractionation (38 Gy [RBE] in 5 fractions, Arm B) proton therapy. Patients were excluded if they had an American Urological Association Symptom Index (AUASI) > 17. Toxicity was defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and adjusted for pre-treatment toxicities. Patients completed Expanded Prostate Cancer Index Composite + (EPIC), Short Form 12 (SF) and AUASI surveys at baseline and 3, 6, 12, 18, 24 and 36 months. <h3>Results</h3> Forty-six patients were included in Arm A and 84 patients in Arm B. Median follow-up was 50 months. The majority of patients were clinical T1c (89% Arm A, 84.5% Arm B, <i>P</i> = 0.86) and a PSA > 4-10 (80.4% Arm A, 78.6% Arm B, <i>P</i> = 1.00). For both groups, median AUASI was 5 (range 0-14). Four patients (1 Arm A, 3 Arm B) had died at the time of last follow-up, none related to their prostate cancer or treatment. Between the two arms, no significant differences were noted in acute treatment-related genitourinary (GU) or gastrointestinal (GI) toxicities: acute GU grade ≥ 2 (0% Arm A, 5% Arm B), GU grade ≥ 3 (0% each arm), GI grade ≥ 2 (0% Arm A, 2% Arm B), grade ≥ 3 (0% each arm). Similarly, no significant differences were noted in late treatment-related GU or GI toxicities: late GU grade ≥ 2 (26% Arm A, 33% Arm B), GU grade ≥ 3 (2% Arm A, 1% Arm B), GI grade ≥ 2 (13% Arm A, 19% Arm B), GI grade ≥ 3 (0% each arm). When analyzing QOL by arm and timepoints, only EPIC Overall scores at 36 months were clinically significantly different (> MID) between the two arms with Arm B having improved scores (+29.62 points, <i>P</i> = 0.02). Other QOL domains (EPIC Urinary, EPIC Bowel, AUASI) were not clinically significantly different between the two arms across timepoints. <h3>Conclusion</h3> In a phase III randomized controlled trial comparing extreme hypofractionation to standard fractionation for the treatment of prostate cancer, no significant differences for treatment-related acute or late, grade ≥ 2 or ≥ 3, toxicity were found for GU or GI toxicities. Additionally, improved EPIC Overall scores at 36 months were found in patients treated with extreme hypofractionation. This trial was registered with Western IRB 20101536, and NCT01230866.

Non-invasive Urine Test for Molecular Classification of Clinical Significance in Newly Diagnosed Prostate Cancer Patients.

Objective: To avoid over-treatment of low-risk prostate cancer patients, it is important to identify clinically significant and insignificant cancer for treatment decision-making. However, no accurate test is currently available.Methods: To address this unmet medical need, we developed a novel gene classifier to distinguish clinically significant and insignificant cancer, which were classified based on the National Comprehensive Cancer Network risk stratification guidelines. A non-invasive urine test was developed using quantitative mRNA expression data of 24 genes in the classifier with an algorithm to stratify the clinical significance of the cancer. Two independent, multicenter, retrospective and prospective studies were conducted to assess the diagnostic performance of the 24-Gene Classifier and the current clinicopathological measures by univariate and multivariate logistic regression and discriminant analysis. In addition, assessments were performed in various Gleason grades/ISUP Grade Groups.Results: The results showed high diagnostic accuracy of the 24-Gene Classifier with an AUC of 0.917 (95% CI 0.892–0.942) in the retrospective cohort (n = 520), AUC of 0.959 (95% CI 0.935–0.983) in the prospective cohort (n = 207), and AUC of 0.930 (95% 0.912-CI 0.947) in the combination cohort (n = 727). Univariate and multivariate analysis showed that the 24-Gene Classifier was more accurate than cancer stage, Gleason score, and PSA, especially in the low/intermediate-grade/ISUP Grade Group 1–3 cancer subgroups.Conclusions: The 24-Gene Classifier urine test is an accurate and non-invasive liquid biopsy method for identifying clinically significant prostate cancer in newly diagnosed cancer patients. It has the potential to improve prostate cancer treatment decisions and active surveillance.

MP11-06 PREDICTORS OF GLEASON GRADE UPGRADING ON WHOLEMOUNT PATHOLOGY AFTER MRI-TARGETED VERSUS SYSTEMATIC BIOPSY

You have accessJournal of UrologyProstate Cancer: Staging (MP11)1 Sep 2021MP11-06 PREDICTORS OF GLEASON GRADE UPGRADING ON WHOLEMOUNT PATHOLOGY AFTER MRI-TARGETED VERSUS SYSTEMATIC BIOPSY Nabila Khondakar, Michael Ahdoot, Luke O'Connor, Michael Daneshvar, Nitin Yerram, Cheyenne Williams, Jeunice Owens-Walton, Sandeep Gurram, Patrick Gomella, Jillian Egan, Sherif Mehralivand, Maria Merino, Bradford Wood, Baris Turkbey, and Peter Pinto Nabila KhondakarNabila Khondakar More articles by this author , Michael AhdootMichael Ahdoot More articles by this author , Luke O'ConnorLuke O'Connor More articles by this author , Michael DaneshvarMichael Daneshvar More articles by this author , Nitin YerramNitin Yerram More articles by this author , Cheyenne WilliamsCheyenne Williams More articles by this author , Jeunice Owens-WaltonJeunice Owens-Walton More articles by this author , Sandeep GurramSandeep Gurram More articles by this author , Patrick GomellaPatrick Gomella More articles by this author , Jillian EganJillian Egan More articles by this author , Sherif MehralivandSherif Mehralivand More articles by this author , Maria MerinoMaria Merino More articles by this author , Bradford WoodBradford Wood More articles by this author , Baris TurkbeyBaris Turkbey More articles by this author , and Peter PintoPeter Pinto More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001984.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Despite limitations in diagnostic accuracy, transrectal ultrasound guided-systematic biopsy remains the most common method of prostate cancer (PCa) staging. Many low-risk PCa patients are deemed eligible for active surveillance based on systematic biopsy alone. The objective of this study was to analyze characteristics of patients eligible for AS based on systematic biopsy, who later underwent radical prostatectomy and were found to have Gleason Grade (GG) ≥3 disease. METHODS: Patients were enrolled in a nationally registered clinical trial to evaluate the use of MRI-targeted combined biopsy (NCT00102544). We queried our institutional database for patients who underwent radical prostatectomy between June 2007 and July 2020. Patients with GG1 or GG2 on systematic biopsy were included. Upgrading was determined by comparing GG on systematic and targeted biopsies, to GG on wholemount prostate specimen. Logistic regression models adjusted for age, BMI, and total prostate volume were used to identify predictors of upgrading to GG ≥3 disease. Chi-squared tests were used to compare categorical variables. RESULTS: A total of 773 patients who underwent radical prostatectomy between June 2007 and July 2020 were identified in our institutional database. Among patients who underwent combined biopsy (n = 495), 280 were diagnosed with GG1 (n=03) or GG2 (n=177) on systematic biopsy. The rate of upgrading to GG ≥ 3 was significantly higher for systematic than targeted biopsy (20.0% vs 5.0%, p<0.0001). Increased age at time of surgery was associated with increased odds of upgrading to GG≥ 3 (OR: 1.13, 95% CI: 1.03–1.25, p=.014). Targeted biopsy GG was associated with increased odds of upgrading to GG ≥3 on wholemount pathology (OR: 2.91, 95% CI: 1.74-5.38, p<0.001). Total number of lesions found on MRI was associated with lower odds of upgrading (OR: 0.41, 95% CI: 0.21-0.70, p=0.003). PSA at time of surgery, BMI, highest PIRADS score on MRI, and total prostate volume on MRI were not associated with upgrading to GG ≥ 3 on wholemount pathology (p>0.05). CONCLUSIONS: Approximately 1 in 5 patients eligible for AS based on 12-core TRUS-systematic biopsy portion of combined biopsy have GG ≥3 on wholemount histopathology after radical prostatectomy. Older age, GG on MRI-targeted biopsy, and fewer total lesions on pre-biopsy MRI are associated with upgrading to GG ≥3 on wholemount histopathology. Our findings support the use of MRI-targeted biopsy for risk-stratifying patients on AS. Source of Funding: NIH Intramural Funding, NIH Medical Research Scholars Program, Foundation for the NIH © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e179-e180 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Nabila Khondakar More articles by this author Michael Ahdoot More articles by this author Luke O'Connor More articles by this author Michael Daneshvar More articles by this author Nitin Yerram More articles by this author Cheyenne Williams More articles by this author Jeunice Owens-Walton More articles by this author Sandeep Gurram More articles by this author Patrick Gomella More articles by this author Jillian Egan More articles by this author Sherif Mehralivand More articles by this author Maria Merino More articles by this author Bradford Wood More articles by this author Baris Turkbey More articles by this author Peter Pinto More articles by this author Expand All Advertisement Loading ...

PD17-06 PSA VELOCITY PREDICTS CLINICAL PROGRESSION IN AFRICAN AMERICAN AND NON-HISPANIC WHITE PATIENTS WITH LOW RISK PROSTATE CANCER UNDERGOING ACTIVE SURVEILLANCE

You have accessJournal of UrologyProstate Cancer: Localized: Active Surveillance I (PD17)1 Sep 2021PD17-06 PSA VELOCITY PREDICTS CLINICAL PROGRESSION IN AFRICAN AMERICAN AND NON-HISPANIC WHITE PATIENTS WITH LOW RISK PROSTATE CANCER UNDERGOING ACTIVE SURVEILLANCE Juan Javier-DesLoges, Tyler Nelson, Rishi Deka, Patrick Courtney, Vinit Nalawade, Loren Mell, James Murphy, J. Kellogg Parsons, and Brent Rose Juan Javier-DesLogesJuan Javier-DesLoges More articles by this author , Tyler NelsonTyler Nelson More articles by this author , Rishi DekaRishi Deka More articles by this author , Patrick CourtneyPatrick Courtney More articles by this author , Vinit NalawadeVinit Nalawade More articles by this author , Loren MellLoren Mell More articles by this author , James MurphyJames Murphy More articles by this author , J. Kellogg ParsonsJ. Kellogg Parsons More articles by this author , and Brent RoseBrent Rose More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001999.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The utility of prostate-specific antigen velocity (PSAV) to predict clinical progression in patients with localized prostate cancer (PC) on active surveillance remains unclear, and in African American (AA) patients on active surveillance remains undefined. METHODS: We performed a cohort analysis using the national US Veterans Affairs Informatics and Computing Infrastructure (VINCI). We identified 5296 patients diagnosed with localized prostate cancer (PC) from 2001 to 2015 managed with active surveillance. Follow-up extended through March 31, 2020. We defined low-risk PC as ISUP grade group 1 (GG1) clinical tumor stage ≤ 2A, and PSA level ≤ 10 ng/dl; and active surveillance as no definitive treatment within the first year after diagnosis with at least one additional staging biopsy after diagnostic biopsy. The primary outcome was grade progression on repeat biopsy/prostatectomy defined as GG2 or GG3. The secondary outcome was incident metastases. Cumulative incidence functions and multivariable Cox proportional hazards models were used to test associations between PSAV and outcomes. RESULTS: The final cohort included 3919 Non-Hispanic White patients (NHW) (74%) and 1377 AA (26%) patients. GG2 progression on repeat biopsy occurred in 2062 (38.9%) patients, with a cumulative incidence (CI) of 43.2 % and GG3 progression occurred in 728 (13.7%) patients, with a CI of 18% at seven years. Fifty-four (0.8%) patients developed metastases, with a CI of 1.4% at ten years. In unadjusted analyses, compared to NHW patients, AA patients were significantly more likely to progress to GG2 (52.8% vs 39.8%, p<0.001), and GG3 (22.2% vs 16.8%, p=0.01). On MV analysis, PSAV was a significant predictor of GG2 (HR 1.32 [1.26-1.39]), GG3 (1.5 [1.40-1.62]), and metastases (1.38 [1.10-1.74]). A significant interaction term between race and PSAV indicated the need for different PSAV thresholds for AA and NHW men. Based on maximally selected rank statistics, optimal thresholds for separating outcomes were different in AA vs NHW men. (0.44 vs. 1.18). CONCLUSIONS: In this analysis of PSAV in low-risk prostate cancer patients on AS—to our knowledge, the largest to date for AA patients—we observed that PSAV is a robust predictor of upgrading on restaging biopsy as well as metastasis. Compared to NHW patients, AA patients were more likely to progress at lower values of PSAV and therefore merit close follow-up on active surveillance protocols. Source of Funding: Department of Defense, grant number W81XWH-17-PCRP-PRA (RD and BSR) © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e286-e287 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Juan Javier-DesLoges More articles by this author Tyler Nelson More articles by this author Rishi Deka More articles by this author Patrick Courtney More articles by this author Vinit Nalawade More articles by this author Loren Mell More articles by this author James Murphy More articles by this author J. Kellogg Parsons More articles by this author Brent Rose More articles by this author Expand All Advertisement Loading ...

National consensus quality indicators to assess quality of care for active surveillance in low-risk prostate cancer: An evidence-informed, modified Delphi survey of Canadian urologists/radiation oncologists.

Although many low-risk prostate cancer (PCa) patients worldwide currently receive active surveillance (AS), adherence to clinical guidelines on AS and variations in care at the population level remain poorly understood. We sought to develop system-level quality indicators (QIs) and performance measures for benchmarking the quality of care during AS. Convenience sampling methods were used to identify an expert panel among practicing urologists and radiation oncologists across Canada. QI development involved two phases: 1) proposed QIs were identified through a literature search and published clinical guidelines on AS; and 2) indicators were selected through a modified Delphi process during which each panelist independently rated each indicator based on clinical importance. QI items were chosen as appropriate measures for quality of AS care if they met prespecified criteria (disagreement index <1 and median importance of ≥7 on a nine-point scale). Among 42 invited expert panel members, the response rate was 45% (n=19). Expert panel members were well-represented by type of physician (84% urologists, 16% radiation oncologists) and practice setting (79% academic, 21% non-academic). The expert panel endorsed 20 of 27 potential indicators as appropriate for measuring quality of AS care. We developed a set of QIs to measure AS care using published guidelines and clinical experts. Use of the indicators will be assessed for feasibility in healthcare databases. Reporting quality of care with these AS indicators may enhance adherence, reduce variation in care, and improve patient outcomes among low-risk PCa patients on AS.

Indication for Active Surveillance in the Era of MRI-Targeted Prostate Biopsies

Introduction: Active surveillance (AS) strategies were established to avoid overtreatment of low-risk prostate cancer (PCa) patients. Low tumor volume represents one indication criteria; however, applying this criterion after MRI-targeted prostate biopsies may lead to overestimation of tumor volume; wherefore, patients suitable for AS would be exposed to the risk of overtreatment. Methods: This retrospective analysis included 318 patients in which PCa was detected by MRI-TRUS fusion prostate biopsy. Classic and extended indication for AS included Gleason 6 and Gleason 3 + 4 cancer, respectively. We assessed the effect of targeted biopsies and temporary rating strategies on eligibility for AS and developed new “composite” algorithms to more accurately assess eligibility for AS. Results: Forty-four (13.8%) and 60 (18.9%) of the 318 patients qualified for AS according to “classic” and “extended” criteria, respectively. Application of the “composite 1” definition led to AS eligibility of 52 of 248 patients (20.97%) in the classic and of 77 of 248 patients (31.05%) in the “extended” group. Conclusions: We could demonstrate that classic algorithms led to ineligibility of patients for AS. We propose a new rating algorithm to improve tumor assessment for a more accurate indication for AS.

A comparative analysis between low-dose-rate brachytherapy and external beam radiation therapy for low- and intermediate-risk prostate cancer in Asian men

Objective To report the long-term clinical outcomes of low-risk (LR) and intermediate-risk (IR) prostate cancer patients treated with low-dose-rate brachytherapy (LDR-BT) and external beam radiation therapy (EBRT). Patients and Methods Men with biopsy-proven low- and intermediate-risk prostate cancer received EBRT and LDR-BT in an Asian academic center from 2000 to 2019 were reviewed. Kaplan–Meier survival analysis was performed to compare biochemical failure-free survival (bFFS) and overall survival (OS) between LDR and EBRT in the low- and intermediate-risk cohorts. Results 642 patients (521 EBRT and 121 LDR-BT) with low- and intermediate-risk prostate cancer were included for analysis. In the intermediate-risk group, 5- and 10-year bFFS was 96%, 89% and 86%, 61% for LDR-BT and EBRT, respectively. LDR-BT was associated with a statistically significant improvement of bFFS in the intermediate-risk cohort (HR 2.7, p = 0.02). In the low-risk cohort, no difference of bFFS was found between LDR-BT and EBRT (HR 1.9, p = 0.08). Hormone therapy was more common in EBRT than LDR-BT for intermediate-risk group (71% versus 44%, p < 0.05). Prostate cancer-specific mortality was low in both EBRT (1%) and LDR-BT (2%) cohorts. No significant difference in OS was found between LDR-BT and EBRT in low- and intermediate-risk group (HR 2.1, p = 0.2 and HR = 1.7, p = 0.3). Conclusion In our retrospective study, LDR-BT is associated with superior bFFS compared with EBRT in Asian men with intermediate-risk prostate cancer.

P1035 - Low risk prostate cancer patients with negative confirmatory biopsies during active surveillance are at low risk of being treated for their disease

P1035 - Low risk prostate cancer patients with negative confirmatory biopsies during active surveillance are at low risk of being treated for their disease

Using the Movember Foundation's GAP3 cohort to measure the effect of active surveillance on patient-reported urinary and sexual function-a retrospective study in low-risk prostate cancer patients.

BackgroundActive surveillance (AS) for low-risk prostate cancer (PCa) is intended to overcome potential side-effects of definitive treatment. Frequent prostate biopsies during AS may, however, impact erectile (EF) and urinary function (UF). The objective of this study was to test the influence of prostate biopsies on patient-reported EF and UF using multicenter data from the largest to-date AS-database.MethodsIn this retrospective study, data analyses were performed using the Movember GAP3 database (v3.2), containing data from 21,169 AS participants from 27 AS-cohorts worldwide. Participants were included in the study if they had at least one follow-up prostate biopsy and completed at least one patient reported outcome measure (PROM) related to EF [Sexual Health Inventory for Men (SHIM)/five item International Index of Erectile Function (IIEF-5)] or UF [International Prostate Symptom Score (IPSS)] during follow-up. The longitudinal effect of the number of biopsies on either SHIM/IIEF-5 or IPSS were analyzed using linear mixed models to adjust for clustering at patient-level. Analyses were stratified by center; covariates included age and Gleason Grade group at diagnosis, and time on AS.ResultsA total of 696 participants completed the SHIM/IIEF-5 3,175 times, with a median follow-up of 36 months [interquartile range (IQR) 20–55 months]. A total of 845 participants completed the IPSS 4,061 times, with a median follow-up of 35 months (IQR 19–56 months). The intraclass correlation (ICC) was 0.74 for the SHIM/IIEF-5 and 0.68 for the IPSS, indicating substantial differences between participants’ PROMs. Limited heterogeneity between cohorts in the estimated effect of the number of biopsies on either PROM were observed. A significant association was observed between the number of biopsies and the SHIM/IIEF-5 score, but not for the IPSS score. Every biopsy was associated with a decrease in the SHIM/IIEF-5 score of an average 0.67 (95% CI, 0.47–0.88) points.ConclusionsRepeated prostate biopsy as part of an AS protocol for men with low-risk PCa does not have a significant association with self-reported UF but does impact self-reported sexual function. Further research is, however, needed to understand whether the effect on sexual function implies a negative clinical impact on their quality of life and is meaningful from a patient’s perspective. In the meantime, clinicians and patients should anticipate a potential decline in erectile function and hence consider incorporating the risk of this harm into their discussion about opting for AS and also when deciding on the stringency of follow-up biopsy schedules with long-term AS.

PR2 Concordance of Preferences and Treatment Choice Using Choice Based Adaptive Conjoint Analysis

A patient needs to be aware of all treatment options to assess which fits best with individual goals. Objective of this study is to assess the association between value markers (utility levels) and treatment choice in men with localized prostate cancer. In this randomized controlled trial, localized prostate cancer patients were randomized to a preference assessment intervention, PreProCare, or to usual care. Patient reported outcomes were assessed at baseline, and at 3, 6, 12 and 24-month follow-up. Treatment choice and other clinical data were obtained from medical charts. We compared treatment choice across intervention groups by prostate cancer risk categories. Hierarchical Bayesian random effects model generated utilities and mean relative importance scores of treatment attributes. For low-risk patients from intervention group, GLM log-link model was used to analyze the association between value markers of treatment attributes and uptake of active surveillance. Total of 743 localized prostate cancer patients were randomized to the PreProCare intervention (n=371) or to usual care (n=372). Demographics and clinical characteristics were comparable by intervention status. Among low-risk patients, higher proportion from intervention group was receiving active surveillance, compared to usual care group (P <.001). Among 117 low-risk prostate cancer patients from intervention group, older age (OR=1.2, CI=1.09, 1.31), sexual function (OR=1.5, CI=1.1, 2.1), fear of surgery (OR=1.5, CI=1.1, 2.2), recovery time (OR=1.1, CI=1.02, 1.9) were associated with higher odds of being on active surveillance. Survival (OR=0.68, CI=0.49, 0.96) was associated with lower odds of being on active surveillance. We observed that patient treatment choice aligned with their values. Value markers (or utility levels) of treatment such as survival, recovery time and sexual function were associated with active surveillance in low-risk prostate cancer patients. Preference assessment intervention can help prostate cancer patients reveal their preferences, leading to better alignment with treatment decision.

Discovery of primary prostate cancer biomarkers using cross cancer learning

Prostate cancer (PCa), the second leading cause of cancer death in American men, is a relatively slow-growing malignancy with multiple early treatment options. Yet, a significant number of low-risk PCa patients are over-diagnosed and over-treated with significant and long-term quality of life effects. Further, there is ever increasing evidence of metastasis and higher mortality when hormone-sensitive or castration-resistant PCa tumors are treated indistinctively. Hence, the critical need is to discover clinically-relevant and actionable PCa biomarkers by better understanding the biology of PCa. In this paper, we have discovered novel biomarkers of PCa tumors through cross-cancer learning by leveraging the pathological and molecular similarities in the DNA repair pathways of ovarian, prostate, and breast cancer tumors. Cross-cancer disease learning enriches the study population and identifies genetic/phenotypic commonalities that are important across diseases with pathological and molecular similarities. Our results show that ADIRF, SLC2A5, C3orf86, HSPA1B are among the most significant PCa biomarkers, while MTRNR2L1, EEPD1, TEPP and VN1R2 are jointly important biomarkers across prostate, breast and ovarian cancers. Our validation results have further shown that the discovered biomarkers can predict the disease state better than any randomly selected subset of differentially expressed prostate cancer genes.

The effect of race/ethnicity on active treatment rates among septuagenarian or older low risk prostate cancer patients

BackgroundRace/ethnicity may predispose to higher active treatment rates in septuagenarian or older low risk prostate cancer (CaP) patients. We tested this hypothesis within a contemporary North American cohort. Material and MethodsWe relied on the Surveillance, Epidemiology and End Results (SEER) database 2010-2016. The effect of race/ethnicity was tested in univariable and multivariable logistic regression analyses predicting definitive treatment administration. Treatment rates (no local treatment [NLT], external beam radiotherapy [EBRT], radical prostatectomy [RP] and brachytherapy) were examined without, as well as with adjustment for age, socioeconomic status, marital status, residence type, year of diagnosis, other-cause mortality, prostate-specific antigen (PSA) and clinical T stage across races/ethnicities. Moreover, temporal trend analyses were performed. ResultsOf 15,118 septuagenarian or older low risk CaP patients, 11,509 (76.1%) were Caucasian, 1,613 (10.7%) African-American, 1,293 (8.5%) Hispanic/Latino and 703 (4.7%) Asian. No clinically meaningful differences were recorded between races/ethnicities with respect to age at diagnosis, PSA, clinical T stage and percentage of positive biopsy cores. Conversely, clinically meaningful and statistically significant differences were identified in socioeconomic status and treatment modality. Specifically, treatment rates ranged as follows: NLT 41.8-48.2, EBRT 23.0-29.9, RP 13.8-21.8 and brachytherapy 6.4-9.9% across race/ethnicies. After adjustment for patient and tumor characteristics, NLT, EBRT, RP and brachytherapy rates showed virtually no residual heterogeneity between races/ethnicities. Finally, in temporal trend analyses, EBRT rates decreased in all races/ethnicities. Conversely, RP and brachytherapy rates did not change over time. ConclusionThe rates of active treatment in septuagenarian or older low risk CaP patients are surprisingly elevated in all races/ethnicities, even though they decreased over time. All differences in active treatment rates according to race/ethnicity depend on baseline patient and tumor characteristics.

Long-term and pathological outcomes of low- and intermediate-risk prostate cancer after radical prostatectomy: implications for active surveillance

PurposeThe safety of active surveillance (AS) in favorable intermediate-risk (FIR) prostate cancer (PCa) remains uncertain. To provide guidance on clinical decision-making, we examined long-term and pathological outcomes of low-risk and intermediate-risk PCa patients after radical prostatectomy (RP).MethodsThe study involved 5693 patients diagnosed between 1994 and 2019 with low-risk, FIR, and unfavorable intermediate-risk (UIR) PCa (stratification according to the AUA guidelines) who underwent RP. Pathological outcomes were compared, and Kaplan–Meier analysis determined biochemical recurrence-free survival (BRFS) and cancer-specific survival (CSS) at 5, 10, 15, and 20 years. Multiple Cox regression was used to simultaneously control for relevant confounders.ResultsThose at FIR had higher rates of upgrading and upstaging (12.8% vs. 7.2%, p < 0.001; 19.8% vs. 12.0%, p < 0.001) as well as pathological tumor and node stage (≥ pT3a: 18.8% vs. 11.6%, p < 0.001; pN1: 2.7% vs. 0.8%, p > 0.001) compared to patients at low risk. The 20-year BRFS was 69%, 65%, and 44% and the 20-year CSS was 98%, 95%, and 89% in low-risk, FIR, and UIR patients. On multiple Cox regression, FIR was not associated with a worse BRFS (HR 1.07, CI 0.87–1.32), UIR was associated with a worse BRFS (HR 1.49, CI 1.20–1.85).ConclusionPatients at FIR had only slightly worse pathological and long-term outcomes compared to patients at low risk, whereas the difference compared to patients at UIR was large. This emphasizes AS in these patients as a possible treatment strategy in well-counseled patients.

PO42: High Dose Rate Brachytherapy Monotherapy, for Low and Intermediate Low Risk Prostate Cancer Patients. Early Analysis

PO42: High Dose Rate Brachytherapy Monotherapy, for Low and Intermediate Low Risk Prostate Cancer Patients. Early Analysis

PO42: High Dose Rate Brachytherapy Monotherapy, for Low and Intermediate Low Risk Prostate Cancer Patients. Early Analysis

Purpose: To evaluate biochemical progression free survival (b-PFS) and toxicity in a consecutive cohort of 76 patients with low risk (LR) and favorable intermediate risk (FIR) prostate carcinoma (PCa) treated with High Dose Rate Monotherapy (HDRM).

Use of multiparametric magnetic resonance imaging (mpMRI) in active surveillance for low-risk prostate cancer: a scoping review on the benefits and harm of mpMRI in different biopsy scenarios.

There is uncertainty on how multiparametric MRI (mpMRI) and MRI-targeted biopsy (MRI-TB) can be best used to manage low-risk prostate cancer patients on Active Surveillance (AS). We performed a scoping review to evaluate the benefits and harm associated with four different biopsy scenarios in which mpMRI can be implemented in AS. Medline, Embase and Cochrane Library databases (1 January 2013-18 September 2020) were searched. Included studies were on men with low-risk prostate cancer enrolled in AS, who had mpMRI ± MRI-TB and standard prostate biopsy (systematic transrectal ultrasound or transperineal saturation biopsy), at confirmatory or follow-up biopsy. Primary outcomes were the number of Gleason score upgrades and biopsies avoided. Eight confirmatory biopsy studies and three follow-up biopsy studies were included. Compared to the benchmark of using standard biopsy (SB) for all men, the addition of MRI-TB increased the detection of Gleason score upgrades at both confirmatory (6/8 studies) and follow-up biopsy (3/3 studies), with increments of 1.7-11.8 upgrades per 100 men. 6/7 studies suggested that the use of a positive mpMRI to triage men for MRI-TB or SB alone would detect fewer Gleason score upgrades than benchmark at confirmatory biopsy, but the combination of MRI-TB and SB would detect more upgrades than the benchmark. For follow-up biopsy, the evidence on mpMRI triage biopsy scenarios was inconclusive due to the small number of included studies. The addition of MRI-TB to benchmark (SB for all men) maximises the detection of Gleason score upgrades at confirmatory and follow-up biopsy. When the use of mpMRI to triage men for a biopsy is desired, the combination of MRI-TB and SB should be considered for men with positive mpMRI at confirmatory biopsy. The evidence on mpMRI triage scenarios was inconclusive in the follow-up biopsy setting.