About this trial
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 hypotheses are 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) and overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.
Patient Profile
Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA)
Where’s this trial being run?
Tallaght University Hospital and St Vincents University Hospital
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
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QuestionsSummary Data
| Name: | MK-5684-004 |
|---|---|
| Number: | 24-03 |
| Full Title: | A Phase 3, Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) |
| Principal Investigator: | Prof Ray McDermott |
|---|---|
| Type: | Industry Sponsored |
| Sponsor: | Merck Sharp & Dohme LLC |
| Recruitment Started: |
Global: Ireland: |
| Global Recruitment Target: | 1200 |
|---|---|
| Ireland Recruitment Target: | 14 |