Summary

• No prospective, randomized, head-to-head clinical trials comparing the efficacy and safety of AKEEGA with ERLEADA have been conducted.
• ProBio (Prostate-Biomarker, NCT03903835) is an ongoing, phase 3, outcome-adaptive, multiarm, multiple-assignment, randomized, open-label, international biomarker-driven platform study in patients with de novo metastatic hormone-sensitive prostate cancer (mHSPC) or first-line (L1) metastatic castration-resistant prostate cancer (mCRPC). Patients entering in the mHSPC phase will be randomized to receive either standard of care (SOC) or an experimental treatment including abiraterone acetate, AKEEGA, or ERLEADA based on predefined biomarker signatures. The study has a planned enrollment of 750 patients. The efficacy and safety results have not been published.^1,2
• An ongoing, phase 2, parallel-group, randomized trial evaluating the effectiveness of niraparib and abiraterone acetate, the components of AKEEGA, vs ERLEADA in patients with high-risk localized or locally advanced prostate cancer after SOC radiation therapy has been identified (NCT04947254).³

Product Labeling

AKEEGA (niraparib and abiraterone acetate) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/AKEEGA-pi.pdf.

ERLEADA (apalutamide) [Prescribing Information]. Horsham, PA: Janssen Products, LP; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/ERLEADA-pi.pdf.

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and DerwentDrug File (and/or other resources, including internal/external databases) was conducted on 24 May 2025. Summarized in this response are relevant data pertaining to this topic in patients with prostate cancer.