rechARge: a randomized phase III trial of the androgen receptor ligand-directed degrader, BMS-986365, vs investigator's choice in patients with mCRPC
- Author(s)
- Chi, KN; McKay, RR; Sandhu, S; Arranz, JA; Barthélémy, P; Hadaschik, B; Matsubara, N; Shore, ND; Ye, D; Cascella, T; Irincheeva, I; Kreiser, S; Thiery-Vuillemin, A; Rathkopf, DE;
- Details
- Publication Year 2025-06-02,Volume 21,Issue #14,Page 1771-1777
- Journal Title
- Future Oncology
- Publication Type
- Research article
- Abstract
- 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.Clinical trial registration: www.clinicaltrials.gov identifier is NCT06764485.; What is this article about?Prostate cancer is the second most common cancer and the fifth most common cancer-related cause of death in men worldwide. Prostate cancer is primarily driven by the androgen receptor pathway, making it an optimal target to inhibit tumor growth. Hormone therapy (also known as hormonal castration), which works by blocking or reducing the production of male hormones known as androgens, is a common treatment for prostate cancer. However, for most people, their disease eventually becomes resistant to hormone therapy; this is referred to as metastatic castration-resistant prostate cancer (mCRPC). New drugs are urgently needed that can prolong the life of men with mCRPC. The study described here looks at a new drug for treating patients with mCRPC.What is the study about?The rechARge study is evaluating a new oral drug called BMS-986365 which removes a key protein in the development of prostate cancer called the androgen receptor (AR). BMS-986365 works in two ways: by eliminating the AR protein and also stopping the AR from contributing to tumor growth.What will the results of the study tell us?The rechARge study is a randomized, global phase III trial including patients with mCRPC that have developed resistance to drugs inhibiting the AR pathway. The study will determine whether patients survive longer without their disease worsening when treated with BMS-986365 compared to other standard-of-care options, including chemotherapy. The study will also evaluate the safety of BMS-986365.; eng
- Publisher
- Taylor & Francis
- Keywords
- Bms‑986365; androgen receptor; clinical trial; ligand-directed degrader; metastatic castration resistant prostate cancer; phase III; protein degradation; protocol
- Department(s)
- Medical Oncology
- Publisher's Version
- https://doi.org/10.1080/14796694.2025.2502318
- Open Access at Publisher's Site
https://doi.org/10.1080/14796694.2025.2502318- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2025-06-19 05:00:52
Last Modified: 2025-06-19 05:00:59