Apalutamide for High-Risk Localized Prostate Cancer Following Radical Prostatectomy in Apa-RP: A Multicenter, Open-Label, Single-Arm Phase 2 Study

Document Type

Conference Proceeding

Publication Date

5-2024

Publication Title

Journal of Urology

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=28days). 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 (range43.0-939.0) 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 re-ported 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) and10.2% (n[11) of pts required treatment dose reduction/interruption o rdiscontinuation 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 a100% 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.

Volume

211

Issue

5S

First Page

e4

Last Page

e5

Comments

American Urological Association Annual Meeting, May 3-6, 2024, San Antonio, TX

DOI

10.1097/01.JU.0001015816.87470.c9.07

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