P2-07 APALUTAMIDE FOR HIGH-RISK LOCALIZED PROSTATE CANCER FOLLOWING RADICAL PROSTATECTOMY IN Apa-RP: A Multicenter, Open-Label, Single-Arm Phase 2 Study

You have accessJournal of UrologyParadigm-shifting, Practice-changing Clinical Trials in Urology (P2)1 May 2024P2-07 APALUTAMIDE FOR HIGH-RISK LOCALIZED PROSTATE CANCER FOLLOWING RADICAL PROSTATECTOMY IN Apa-RP: A Multicenter, Open-Label, Single-Arm Phase 2 Study Neal Shore, Jason Hafron, Daniel Saltzstein, Gordon Brown, Laurence Belkoff, Pankaj Aggarwal, Jennifer Phillips, Amitabha Bhaumik, and Tracy McGowan Neal ShoreNeal Shore , Jason HafronJason Hafron , Daniel SaltzsteinDaniel Saltzstein , Gordon BrownGordon Brown , Laurence BelkoffLaurence Belkoff , Pankaj AggarwalPankaj Aggarwal , Jennifer PhillipsJennifer Phillips , Amitabha BhaumikAmitabha Bhaumik , and Tracy McGowanTracy McGowan View All Author Informationhttps://doi.org/10.1097/01.JU.0001015816.87470.c9.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: Approximately 25% of patients (pts) with high-risk localized prostate cancer (HR LPC) experience disease recurrence within 2 years following radical prostatectomy (RP). The Apa-RP study (NCT04523207) investigated adjuvant treatment with apalutamide and androgen deprivation therapy (ADT) to determine if this combination improved the biochemical recurrence (BCR)-free rate in participants with HR LPC who had undergone RP, compared with historical data from pts with RP alone. METHODS: In this multicenter, open-label, single-arm, Phase 2 study conducted at 27 US community urologic practices, treatment-naïve pts with HR LPC who had undergone RP were treated with apalutamide (240 mg; once daily) and ADT for 12 cycles (1 cycle=28 days). The primary endpoint was confirmed BCR-free rate at 24 months, where BCR is defined as two sequential prostate-specific antigen (PSA) levels >0.2 ng/mL. Secondary endpoints included testosterone recovery rate and safety. Modified intention-to-treat analysis set is reported. RESULTS: 108 pts were enrolled; the median age was 66.0 (range 46.0-77.0) years. The median pre-operative PSA and testosterone at baseline were 7.6 (range 2.2-62.7) ng/dL and 340.0 (range 43.0-939.0) ng/dL, respectively. Confirmed BCR-free rate was 100% at 24 months (90% confidence interval CI 93.0, 100.0) (Figure 1A); unconfirmed BCR-free rate at 24 months was 98.4% (90% CI 92.2, 99.7) (Figure 1B). The serum testosterone recovery (≥150 ng/dL) event rate was 76.4% (95% CI 65.0-84.5) at 12 months following treatment completion. Treatment-emergent adverse events (TEAEs) were reported by 99.1% (n=107) of pts during the study; 22.2% (n=24) were Grade 3 -4, and 14.8% (n=16) were serious AEs. 13.0% (n=14) and 10.2% (n=11) of pts required treatment dose reduction/interruption or discontinuation due to AEs, respectively. CONCLUSIONS: The Apa-RP study results suggest that treatment intensification with 12 months of apalutamide+ADT could become an option for patients with HR LPC undergoing RP, based on a 100% BCR-free survival. 76% of patients had testosterone recovery (≥150 ng/dL) 12 months after treatment completion. The safety profile of apalutamide + ADT was consistent with previous reports. Download PPT Source of Funding: Johnson & Johnson © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5S2May 2024Page: e4 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Neal Shore More articles by this author Jason Hafron More articles by this author Daniel Saltzstein More articles by this author Gordon Brown More articles by this author Laurence Belkoff More articles by this author Pankaj Aggarwal More articles by this author Jennifer Phillips More articles by this author Amitabha Bhaumik More articles by this author Tracy McGowan More articles by this author Expand All Advertisement PDF downloadLoading ...