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)

Conditions

• Metastatic Castration-resistant Prostate Cancer (mCRPC)
• Prostatic Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Opevesostat — DRUG
  Administered orally
• Dexamethasone — DRUG
  Administered orally
• Fludrocortisone acetate — DRUG
  Administered orally
• Hydrocortisone — DRUG
  Administered orally or IM as a rescue drug
• Abiraterone acetate — DRUG
  Administered orally
• Prednisone acetate — DRUG
  Administered orally
• Enzalutamide — DRUG
  Administered orally

Study Details

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.

Key Dates

Start date

Dec 18, 2023

Status verified

Jun 2026

Primary completion

May 10, 2028

Completion

Dec 2, 2030

Study Design

Enrollment

1,314 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Hormone Replacement Therapy (HRT) + Opevesostat
  Participants receive opevesostat 5 mg by oral tablets twice daily (BID) plus dexamethasone 1.5 mg by oral tablets and fludrocortisone acetate 0.1 mg oral tablet once daily (QD) continuously until disease progression. Hydrocortisone 100 mg (oral or intramuscular \[IM\]) will also be provided to participants for use as rescue medication.
• Active Comparator: Alternative Next-Generation Hormonal Agent (NHA)
  Participants receive abiraterone 1000mg QD by oral tablets plus prednisone 5 mg BID by oral tablets or enzalutamide 160 mg QD by oral tablets until disease progression.

Primary Outcome Measure

Radiographic Progression-Free Survival (rPFS) [ Time Frame: Up to approximately 52 months ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (62)

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