OncoMatch/Clinical Trials/NCT06136650
A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)
Is NCT06136650 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for metastatic castration-resistant prostate cancer (mcrpc).
Treatment: Opevesostat · Dexamethasone · Fludrocortisone acetate · Hydrocortisone · Abiraterone acetate · Prednisone acetate · Enzalutamide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage IV
Metastatic disease required
Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography (CT)/magnetic resonance imaging (MRI)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: next-generation hormonal agent — hormone sensitive prostate cancer (HSPC) or castration-resistant prostate cancer (CRPC)
Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) (metastatic hormone-sensitive prostate cancer [mHSPC] or non-metastatic hormone-sensitive prostate cancer [nmHSPC]), or castration-resistant prostate cancer (CRPC) (metastatic castration-resistant prostate cancer [mCRPC] or non-metastatic castration-resistant prostate cancer [nmCRPC]), for at least 8 weeks of NHA treatment (at least 14 weeks of NHA treatment for participants with bone progression)
Cannot have received: taxane-based chemotherapy
Exception: for metastatic castration-resistant prostate cancer (mCRPC)
Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC)
Lab requirements
Blood counts
adequate organ function
Kidney function
adequate organ function
Liver function
adequate organ function
Has adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Arizona Cancer Center - North Campus ( Site 0073) · Tucson, Arizona
- UCLA Hematology/Oncology - Santa Monica ( Site 0044) · Los Angeles, California
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040) · Orange, California
- University of California, Irvine (UCI) Health - UC Irvine Medical Center (0120) · Orange, California
- Stanford Cancer Center ( Site 0036) · Palo Alto, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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