LBA02-09 EMBARK: A PHASE 3 RANDOMIZED STUDY OF ENZALUTAMIDE OR PLACEBO PLUS LEUPROLIDE ACETATE AND ENZALUTAMIDE MONOTHERAPY IN HIGH-RISK BIOCHEMICALLY RECURRENT PROSTATE CANCER

Abstract

You have accessJournal of UrologyCME1 Apr 2023LBA02-09 EMBARK: A PHASE 3 RANDOMIZED STUDY OF ENZALUTAMIDE OR PLACEBO PLUS LEUPROLIDE ACETATE AND ENZALUTAMIDE MONOTHERAPY IN HIGH-RISK BIOCHEMICALLY RECURRENT PROSTATE CANCER Neal D. Shore, Murilo de Almeida Luz, Ugo De Giorgi, Martin Gleave, Geoffrey T. Gotto, Gabriel P. Haas, Miguel Ramirez-Backhaus, Antti Rannikko, Jamal Tarazi, Swetha Sridharan, Jennifer Sugg, Yiyun Tang, Ronald F. Tutrone, Balaji Venugopal, Arnauld Villers, Henry H. Woo, Fabian Zohren, and Stephen J. Freedland Neal D. ShoreNeal D. Shore More articles by this author , Murilo de Almeida LuzMurilo de Almeida Luz More articles by this author , Ugo De GiorgiUgo De Giorgi More articles by this author , Martin GleaveMartin Gleave More articles by this author , Geoffrey T. GottoGeoffrey T. Gotto More articles by this author , Gabriel P. HaasGabriel P. Haas More articles by this author , Miguel Ramirez-BackhausMiguel Ramirez-Backhaus More articles by this author , Antti RannikkoAntti Rannikko More articles by this author , Jamal TaraziJamal Tarazi More articles by this author , Swetha SridharanSwetha Sridharan More articles by this author , Jennifer SuggJennifer Sugg More articles by this author , Yiyun TangYiyun Tang More articles by this author , Ronald F. TutroneRonald F. Tutrone More articles by this author , Balaji VenugopalBalaji Venugopal More articles by this author , Arnauld VillersArnauld Villers More articles by this author , Henry H. WooHenry H. Woo More articles by this author , Fabian ZohrenFabian Zohren More articles by this author , and Stephen J. FreedlandStephen J. Freedland More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003361.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Within 10 years of following definitive therapy for prostate cancer, ∼20–50% of patients experience biochemical recurrence (BCR) characterized by rising prostate-specific antigen (PSA) levels. Given that novel hormone therapy plus androgen deprivation therapy has shown improved survival in metastatic hormone-sensitive prostate cancer, the objective of EMBARK was to evaluate the efficacy and safety of enzalutamide plus leuprolide acetate (LA) and enzalutamide monotherapy, earlier in the disease course in patients with high-risk BCR. METHODS: EMBARK (NCT02319837) is a randomized, phase 3 study of patients with BCR after local therapy considered high-risk: PSA doubling time ≤9 months and PSA ≥2 ng/mL above nadir post-radiotherapy (RT) or ≥1 ng/mL after radical prostatectomy (RP)±postoperative RT. Patients were randomized (1:1:1) to enzalutamide 160 mg/day plus LA (double-blind), placebo plus LA (double-blind), or enzalutamide monotherapy (open-label). LA 22.5 mg was administered every 12 weeks. If the PSA was <0.2 ng/mL at Week 36, therapy was stopped and restarted when PSA was ≥2 ng/mL for patients with primary RP, and ≥5 ng/mL for patients without RP. The primary endpoint, determined by blinded, independent central review, was metastasis-free survival (MFS) with enzalutamide plus LA vs placebo plus LA. Key secondary endpoints were MFS of enzalutamide monotherapy vs placebo plus LA, time to PSA progression, time to antineoplastic therapy, and overall survival of enzalutamide monotherapy or enzalutamide plus LA vs placebo plus LA. RESULTS: A total of 1068 patients were eligible and randomized in the study. The primary hypothesis was that treatment intensification with enzalutamide is associated with improved MFS vs placebo. Results will be analyzed to determine if enzalutamide in combination with LA and enzalutamide monotherapy significantly improved MFS vs placebo with LA and demonstrated an acceptable safety profile consistent with previous randomized controlled trials. Data analysis is ongoing and detailed outcomes will be provided in the late-breaking submission. CONCLUSIONS: The results will address the hypothesis that in patients with high-risk BCR, enzalutamide plus LA and enzalutamide monotherapy were associated with improved MFS vs placebo plus LA. Source of Funding: Pfizer Inc. and Astellas Pharma Inc © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1190 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Neal D. Shore More articles by this author Murilo de Almeida Luz More articles by this author Ugo De Giorgi More articles by this author Martin Gleave More articles by this author Geoffrey T. Gotto More articles by this author Gabriel P. Haas More articles by this author Miguel Ramirez-Backhaus More articles by this author Antti Rannikko More articles by this author Jamal Tarazi More articles by this author Swetha Sridharan More articles by this author Jennifer Sugg More articles by this author Yiyun Tang More articles by this author Ronald F. Tutrone More articles by this author Balaji Venugopal More articles by this author Arnauld Villers More articles by this author Henry H. Woo More articles by this author Fabian Zohren More articles by this author Stephen J. Freedland More articles by this author Expand All Advertisement PDF downloadLoading ...