MP62-17 ENZALUTAMIDE IN PATIENTS WITH LOCALIZED PROSTATE CANCER UNDERGOING ACTIVE SURVEILLANCE: ENACT

Abstract

You have accessJournal of UrologyProstate Cancer: Localized: Active Surveillance II (MP62)1 Sep 2021MP62-17 ENZALUTAMIDE IN PATIENTS WITH LOCALIZED PROSTATE CANCER UNDERGOING ACTIVE SURVEILLANCE: ENACT Neal D. Shore, Joseph Renzulli, Neil E. Fleshner, Courtney M.P. Hollowell, Srinivas Vourganti, Jonathan Silberstein, Rizwan Siddiqui, John Hairston, Dina Elsouda, David Russell, Matthew R. Cooperberg, and Scott A. Tomlins Neal D. ShoreNeal D. Shore More articles by this author , Joseph RenzulliJoseph Renzulli More articles by this author , Neil E. FleshnerNeil E. Fleshner More articles by this author , Courtney M.P. HollowellCourtney M.P. Hollowell More articles by this author , Srinivas VourgantiSrinivas Vourganti More articles by this author , Jonathan SilbersteinJonathan Silberstein More articles by this author , Rizwan SiddiquiRizwan Siddiqui More articles by this author , John HairstonJohn Hairston More articles by this author , Dina ElsoudaDina Elsouda More articles by this author , David RussellDavid Russell More articles by this author , Matthew R. CooperbergMatthew R. Cooperberg More articles by this author , and Scott A. TomlinsScott A. Tomlins More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002102.17AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To compare time to prostate cancer (PC) progression with enzalutamide (ENZA) vs active surveillance (AS) in patients (pts) with low- or intermediate-risk localized PC. METHODS: ENACT (NCT02799745): a Phase 2, open-label, exploratory study conducted in the U.S. and Canada from Jun 2016–Aug 2020. Eligible pts were diagnosed with histologically proven low- or intermediate-risk (Gleason score 3+4) localized PC within 6 months (mo) of screening and under AS. Pts were randomized 1:1 to ENZA monotherapy or ASa and were followed during 1 year (yr) of treatment and up to 2 yr of follow-up. Prior local or systemic PC therapy was not permitted. All biopsies were evaluated with blinded central review. Primary endpoint: time to pathological or therapeutic PC progression.b Secondary endpoints: incidence of negative biopsy at 1 and 2 yr; time to prostate-specific antigen (PSA) progression.c RESULTS: 114 pts were randomized to 160 mg ENZA and 113 to AS (total, n=227). 165 pts (ENZA, n=85; AS, n=80) completed 1 yr of treatment; 117 (n=66; n=51) and 94 (n=54; n=40) completed 1 and 2 yr of follow-up, respectively. Baseline characteristics were similar between arms; 53% of pts were low risk; 47% were intermediate risk. ENZA significantly reduced the risk of PC progression by 46% vs AS (p=0.02; Table). ENZA significantly increased the likelihood of negative biopsy at 1 yr vs AS (p<0.001); the difference was not statistically significant at 2 yr (Table). ENZA significantly delayed PSA progression by 6 mo vs AS (p=0.03). Adverse events (AEs) were reported by 92.0% and 54.9% of pts on ENZA and AS, respectively, during yr 1. The most commonly reported AEs with ENZA during yr 1 were fatigue, gynecomastia, nipple pain, and breast tenderness. The majority of these AEs were ≤grade 2. 3 pts in the ENZA arm died, none of whom were on the study drug at time of death. No deaths were related to treatment or progression of disease. CONCLUSIONS: ENZA monotherapy was well tolerated and significantly reduced the risk of PC progression by 46% vs AS in pts with low- or intermediate-risk localized PC. Pts receiving ENZA were 3.5 times more likely to have a negative biopsy at 1 yr vs AS and had PSA progression delayed by 6 mo vs AS. Source of Funding: Astellas Pharma Inc.; Pfizer Inc., the co-developers of enzalutamide. Editorial: Complete HealthVizion © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e1099-e1099 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Neal D. Shore More articles by this author Joseph Renzulli More articles by this author Neil E. Fleshner More articles by this author Courtney M.P. Hollowell More articles by this author Srinivas Vourganti More articles by this author Jonathan Silberstein More articles by this author Rizwan Siddiqui More articles by this author John Hairston More articles by this author Dina Elsouda More articles by this author David Russell More articles by this author Matthew R. Cooperberg More articles by this author Scott A. Tomlins More articles by this author Expand All Advertisement Loading ...