Lba02-11 updated progression-free survival from presto: a phase 3 randomized study of androgen annihilation for high-risk biochemically relapsed prostate cancer (aft-19)

You have accessJournal of UrologyCME1 Apr 2023LBA02-11 UPDATED PROGRESSION-FREE SURVIVAL FROM PRESTO: A PHASE 3 RANDOMIZED STUDY OF ANDROGEN ANNIHILATION FOR HIGH-RISK BIOCHEMICALLY RELAPSED PROSTATE CANCER (AFT-19) Rahul Aggarwal, Scott Eggener, Glenn Heller, Habn Xiao, David Hillman, Joel Picus, Jennifer Wang, Mary Ellen Taplin, Tanya Dorff, Leonard Appleman, Doug Weckstein, Akash Patnaik, Alan Bryce, Dan Shevrin, Susan Halabi, James Mohler, Daniel Anderson, Arpit Rao, Scott Tagawa, Alan Tan, Charles Ryan, and Michael Morris Rahul AggarwalRahul Aggarwal More articles by this author , Scott EggenerScott Eggener More articles by this author , Glenn HellerGlenn Heller More articles by this author , Habn XiaoHabn Xiao More articles by this author , David HillmanDavid Hillman More articles by this author , Joel PicusJoel Picus More articles by this author , Jennifer WangJennifer Wang More articles by this author , Mary Ellen TaplinMary Ellen Taplin More articles by this author , Tanya DorffTanya Dorff More articles by this author , Leonard ApplemanLeonard Appleman More articles by this author , Doug WecksteinDoug Weckstein More articles by this author , Akash PatnaikAkash Patnaik More articles by this author , Alan BryceAlan Bryce More articles by this author , Dan ShevrinDan Shevrin More articles by this author , Susan HalabiSusan Halabi More articles by this author , James MohlerJames Mohler More articles by this author , Daniel AndersonDaniel Anderson More articles by this author , Arpit RaoArpit Rao More articles by this author , Scott TagawaScott Tagawa More articles by this author , Alan TanAlan Tan More articles by this author , Charles RyanCharles Ryan More articles by this author , and Michael MorrisMichael Morris More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003361.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In the Phase 3 PRESTO study, intensified androgen deprivation therapy (ADT) with apalutamide (Apa) +/- abiraterone acetate plus prednisone (AAP) administered for 1 year prolonged prostate-specific antigen progression-free survival (PSA-PFS) in patients with high-risk biochemically relapse (BCR). We report PSA-PFS with extended follow up. METHODS: PRESTO is a randomized phase 3, open-label trial in patients with BCR following radical prostatectomy and PSADT ≤ 9 months (mo) without distant metastases on conventional imaging (NCT03009981). Patients were randomized 1:1:1 to receive 1 year of ADT, ADT+Apa, or ADT+Apa+AAP, stratified by PSADT (<3 vs 3–9 mo). The primary endpoint of PSA-PFS (>0.2 ng/mL) was compared for each experimental arm vs. control. Analyses were stratified by PSA doubling time and the study was designed to test each hypothesis at a one-sided alpha equal to 0.0125. The first interim analysis at 102 PSA-PFS events in each pair-wise comparison was previously reported (ESMO 2022). We report extended follow up with 146 (ADT vs ADT+Apa) and 142 (ADT vs ADT+Apa+AAP) events, respectively. RESULTS: A total of 504 pts were randomized to ADT (n=167), ADT+Apa (n=168) or ADT+Apa+AAP (n=169). Median time from randomization to last contact was 26.5 and 26.8 months, for the two treatment comparisons. Both experimental arms prolonged PSA-PFS compared to control (Apa+ADT vs ADT HR=0.59, 97.5% CI: 0.40–0.85, 1-sided p-value=0.0006; ADT+Apa+AAP vs ADT, HR=0.53, 97.5% CI: 0.36–0.77, p-value=1-sided 0.00006). Median time to testosterone recovery was 3.9, 3.8 and 4.7 mo in ADT, ADT+Apa, and ADT+Apa+AAP arms, respectively. The most common grade ≥2 adverse event (AE) was hypertension (19%, 23%, 30% in ADT, ADT+Apa and ADT+Apa+AAP arms, respectively). Three (2.1%) and five (3.4%) patients stopped treatment for AEs in the ADT+Apa and ADT+Apa + AAP arms, respectively. Follow-up for quality of life, metastasis-free survival (MFS), and time to castration resistance (TTCR) is ongoing. CONCLUSIONS: In patients with high-risk BCR following radical prostatectomy, intensified ADT with addition of apalutamide or apalutamide plus abiraterone each prolonged biochemical PFS without new safety concerns identified. Follow up is ongoing to determine the impact on longer term endpoints including MFS and time to castration resistance. Source of Funding: AFT, Janssen; https://acknowledgments.alliancefound.org © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1191 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Rahul Aggarwal More articles by this author Scott Eggener More articles by this author Glenn Heller More articles by this author Habn Xiao More articles by this author David Hillman More articles by this author Joel Picus More articles by this author Jennifer Wang More articles by this author Mary Ellen Taplin More articles by this author Tanya Dorff More articles by this author Leonard Appleman More articles by this author Doug Weckstein More articles by this author Akash Patnaik More articles by this author Alan Bryce More articles by this author Dan Shevrin More articles by this author Susan Halabi More articles by this author James Mohler More articles by this author Daniel Anderson More articles by this author Arpit Rao More articles by this author Scott Tagawa More articles by this author Alan Tan More articles by this author Charles Ryan More articles by this author Michael Morris More articles by this author Expand All Advertisement PDF downloadLoading ...