rechARge: a randomized phase III trial of the androgen receptor ligand-directed degrader, BMS-986365, vs investigator’s choice in patients with mCRPC
There is an ongoing need for efficacious, life-prolonging therapies for males with metastatic castration-resistant prostate cancer (mCRPC). mCRPC that progresses after treatment with androgen receptor pathway inhibitors (ARPIs) may still be driven by AR signaling. BMS-986365 is a heterobifunctional, orally bioavailable ligand-directed degrader that targets the AR through a first-in-class dual mechanism of AR degradation and antagonism. Here, we present the study design of rechARge, a phase III, randomized, multicenter, adaptive, two-part, open-label trial evaluating BMS-986365 versus investigator's choice of therapy comprising either docetaxel or a switch to an alternative ARPI (abiraterone or enzalutamide) in patients with mCRPC whose disease has progressed after treatment with one prior ARPI. The primary study objective is to compare the efficacy and safety of BMS-986365 versus investigator's choice of therapy. Approximately 960 patients will be enrolled.<b>Clinical trial registration:</b> www.clinicaltrials.gov identifier is NCT06764485.
Authors
- Dana E. Rathkopf (ORCID: https://orcid.org/0000-0002-4503-7582)
- Antoine Thiery-Vuillemin (ORCID: https://orcid.org/0000-0001-6822-3401)
- José Ángel Arranz
- Nobuaki Matsubara (ORCID: https://orcid.org/0000-0002-9203-4245)
- Dingwei Ye (ORCID: https://orcid.org/0000-0001-7770-9753)
- Rana R. McKay (ORCID: https://orcid.org/0000-0002-0581-7963)
- Shahneen Kaur Sandhu (ORCID: https://orcid.org/0000-0002-8660-4475)
- Boris Hadaschik (ORCID: https://orcid.org/0000-0002-1052-2692)
- Stephanie Kreiser
- Irina Irincheeva
- Neal D. Shore (ORCID: https://orcid.org/0000-0001-5767-0548)
- Teresa Cascella
- Philippe Barthélémy (ORCID: https://orcid.org/0009-0006-3868-186X)
- Kim Nguyen
Institutions
- BC Cancer Agency (CA)
- Memorial Sloan Kettering Cancer Center (US)
- Bristol-Myers Squibb (Germany) (DE)
- The University of Melbourne (AU)
- Peter MacCallum Cancer Centre (AU)
- University of California System (US)
- Hospital General Universitario Gregorio Marañón (ES)
- University of California San Diego (US)
- Fudan University Shanghai Cancer Center (CN)
- Bristol-Myers Squibb (France) (FR)
- Bristol-Myers Squibb (Sweden) (SE)
- National Cancer Center Hospital East (JP)
- Dermatology Specialists (US)
- Carolina Urologic Research Center (US)
- University of Duisburg-Essen (DE)
- Université de Strasbourg (FR)
Publication Details
- Journal
- Future Oncology
- Published
- 2025-06-02
- DOI
- https://doi.org/10.1080/14796694.2025.2502318
- Citations
- 5
- Primary Topic
- Prostate Cancer Treatment and Research
- Type
- article
- Field-Weighted Citation Impact
- 7.59