MK-5684-004
A Study of Opevesostat Versus Alternative Next-generation Hormonal Agent in Metastatic Castration-resistant Prostate Cancer Post One NHA
Recruiting
Trial Purpose
The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as assessed by Blinded Independent Central Review (BICR), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.
View full trial information on Clinicaltrials.gov
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National Trial Reference Number | NCT06136650 |
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MSD Protocol ID |
MK-5684-004 |
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Conditions |
Metastatic Castration-Resistant Prostate Cancer, Prostatic Neoplasms |
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Age Range |
18+ |
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Sex | ALL |
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Trial Phase | 3 |
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Start Date End Date |
2023-12-18 2030-12-02 |
Study Details
Patient Participation
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial.
Conditions
Metastatic Castration-Resistant Prostate Cancer, Prostatic Neoplasms
Trial Phase 3
In Phase 3 trials, researchers try to find out if a treatment works in a large number of people, usually about 1,000 to 5,000 participantsResearch participantIn clinical research, a person who qualifies and agrees to participate in a study. Also called volunteer, trial participant. who have the health condition the treatment is intended to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials may happen in a doctor’s office, a clinic, or a hospital.
Trial Locations
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What can you do next?
If you think this clinical trial might be a good fir and you are interested in taking part, take the next step to see if you are eligible.
Discuss with your doctor or care team
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