About this trial
This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) and 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 participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy. It is hypothesized that opevesostat is superior with respect to OS and rPFS per PCWG Modified RECIST 1.1 as assessed by BICR in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants
Patient Profile
Participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy.
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-5684-003 |
|---|---|
| Number: | 24-02 |
| 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) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy |
| Principal Investigator: | Prof Ray McDermott |
|---|---|
| Type: | Industry Sponsored |
| Sponsor: | Merck Sharp & Dohme LLC |
| Recruitment Started: |
Global: Ireland: |
| Global Recruitment Target: | 1200 |
|---|---|
| Ireland Recruitment Target: | 10 |