Clinical Trials | A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 versus Investigator’s Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with Metastatic Castration-resistant Prostate Cancer. The purpose of this study is help us learn whether the study drug BMS-986365 works in men who have prostate cancer that has spread to other parts of the body (“metastatic”) and has progressed following standard hormonal therapy/radiation therapy or surgery. Experts are still researching the study drug to better understand its potential side effects and how well it works. It also means that Food and Drug Administration (FDA) in the United States or health authorities in other countries have not approved this drug nor its combination with any other drug for use in patients, including patients with your type of cancer. This study will test the safety and efficacy of study drug in a larger number of patients. This study will also assess how you feel about the prostate cancer, its treatment received in this study, and your quality of life as it relates to your health. This study will have two parts. In the first part, two different dose levels of BMS-986365 (300 mg and 400 mg) will be tested versus a comparator that will be chosen by your physician. At the end of the first part, the dose that presents the best benefit-risk profile (= being able to control the cancer while keeping a good tolerance) will be selected to be used in the 2nd part versus the same comparator. The other treatments you can receive in this study (as part of the comparator) are drugs that are approved by the Food and Drug Administration (FDA) in the United States and many countries for the treatment of prostate cancer: abiraterone plus prednisone/prednisolone, enzalutamide, or docetaxel plus prednisone/prednisolone. You may or may not benefit as a result of your participation in this study. However, this study may also help doctors learn things that can help other people in the future. From start to finish you can expect to be in this study for about a minimum of 4 years. This duration may vary based on total study duration. Additional information found here: https://clinicaltrials.gov/study/NCT06764485 For questions, contact: [email protected]