Journal article
Apalutamide for High-Risk Localized Prostate Cancer Following Radical Prostatectomy (Apa-RP)
The Journal of urology, v 212(5), p682
Nov 2024
PMID: 39088398
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Approximately 25% to 50% of patients with high-risk localized prostate cancer experience biochemical recurrence (BCR) within 2 years of radical prostatectomy. The Apa-RP study (NCT04523207) investigated whether adjuvant apalutamide plus androgen deprivation therapy (ADT) in high-risk patients who have undergone radical prostatectomy improved BCR-free survival.
Apa-RP was a multicenter, open-label, single-arm, phase 2 study conducted in community urology practices in the US. High-risk patients who had radical prostatectomy received 12 cycles of apalutamide (240 mg daily; 28-day cycles) plus ADT. The primary end point was BCR-free survival. Secondary end points included testosterone recovery (≥150 ng/dL) and safety.
One hundred eight patients were enrolled; median age was 66.0 years (range 46.0-77.0 years). Median preoperative PSA and baseline testosterone were 7.6 ng/mL (range 2.2-62.7 ng/mL) and 340.0 ng/dL (range 43.0-939.0 ng/dL), respectively. The BCR-free rate at 24 months (12 months after completion of planned therapy) was 100% (90% CI 93-100). Serum testosterone recovery rate (≥50 and ≥150 ng/dL) 12 months after treatment completion was 96% (95% CI 88-98) and 77% (95% CI 66-85), respectively. Overall, 107 (99%) patients experienced treatment-emergent adverse events, with 24 (22%) experiencing grade 3 to 4 events.
In Apa-RP, BCR-free survival was 100% with 77% of patients having testosterone recovery (≥150 ng/dL) within 12 months of actual treatment completion and a manageable safety profile. These results provide proof of concept that treatment intensification with 12 cycles of apalutamide plus ADT could become an option for patients with high-risk localized prostate cancer who have undergone radical prostatectomy.
ClinicalTrials.gov Identifier: NCT04523207.
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Details
- Title
- Apalutamide for High-Risk Localized Prostate Cancer Following Radical Prostatectomy (Apa-RP)
- Creators
- Neal Shore - Carolina Urologic Research CenterJason Hafron - Michigan Institute of UrologyDaniel Saltzstein - Urology San AntonioGordon Brown - Thomas Jefferson University HospitalLaurence Belkoff - Main Line HealthPankaj Aggarwal - Janssen (United States)Jennifer Phillips - Janssen (United States)Amitabha Bhaumik - Janssen (United States)Tracy McGowan - Janssen (United States)
- Publication Details
- The Journal of urology, v 212(5), p682
- Publisher
- LIPPINCOTT WILLIAMS & WILKINS; PHILADELPHIA
- Number of pages
- 10
- Grant note
- Janssen Scientific Affairs
We wish to thank the patients, care partners, family members, and staff from all the units that participated in the study. The authors acknowledge Rushikesh Potdar for his contributions in the study. Medical writing support for the development of this manuscript, under the direction of the authors, was provided by Kerry Guest, PhD, of Ashfield MedComms, an Inizio company.
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Surgery
- Web of Science ID
- WOS:001354408800038
- Scopus ID
- 2-s2.0-85201030702
- Other Identifier
- 991021916912004721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- Web of Science research areas
- Urology & Nephrology