The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with Metastatic Castration-resistant Prostate Cancer (mCRPC) that progressed on or after prior treatment with one Next generation Hormonal Agent (NHA). The purpose of the study is compare an experimental treatment, MK-5684, to the standard treatments for mCRPC, abiraterone acetate and enzalutamide. MK-5684 is considered experimental because it has not been approved by the United States Food and Drug Administration (FDA). The study will test the safety of the trial drug, MK-5684, to see how well the drug works and how participants handle the drug in their body. There will be 2 groups, those that receive the experimental treatment, MK-5684, and those that receive the standard treatments, abiraterone acetate or enzalutamide. Placement in either group will be random, but participants and their doctor will know which group they are placed in.
The study involves receiving the investigational drugs, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, and talking to the study doctor. If you are eligible for the study and consent to participate, your involvement includes a screening visit to check for eligibility for the study. After the screening visit you will enter the treatment phase. During the first 3 months of the treatment phase, you will visit the trial site once every 2 weeks. You will then continue to visit the site about once every 4 weeks. You will be in the trial treatment phase for as long as you tolerate the trial drug(s) and your cancer does not get worse. After you stop getting the trial drug, you will enter the follow-up phase. How long you are in the Follow-up Phase depends on your health, which group you were in, and why you stopped getting trial drugs. You could be in the trial about 4.5 years. How long you are in the trial depends on your health and how well you tolerate the trial drugs.
The study drugs, MK-5684, abiraterone acetate, and enzalutamide, will be provided by the sponsor at no cost to you. All additional study procedures that are beyond your standard medical care, including laboratory tests, physical examinations, and visits to the study center, are provided to you at no charge.
Additional information can be found here: https://clinicaltrials.gov/study/NCT06136650
$50 stipend per visit Hotel Reimbursement: $300 per night Long distance travel, such as train, bus, or airplane, will be eligible for reimbursement