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Hormone Therapy

Opevesostat for Prostate Cancer

Phase 3

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology

Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~54 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying a new drug called MK-5684 for men with advanced prostate cancer who have already received certain treatments. The study will compare MK-5684 to other drugs currently used in this

Who is the study for?

This trial is for men with advanced prostate cancer that has spread and resisted treatment, including hormone therapy and up to two chemo treatments. Participants must have a specific performance status, which measures how well they can do daily activities, and cannot have small cell prostate cancer histology.

What is being tested?

The study compares MK-5684 to other medications like abiraterone acetate or enzalutamide in improving survival without cancer progression. It's open-label, meaning everyone knows what treatment they're getting, and it uses imaging reviews by experts who don't know the patients' group assignments.

What are the potential side effects?

Possible side effects include those common to prostate cancer treatments such as fatigue, digestive issues, hormonal changes (like hot flashes), skin reactions, blood pressure changes due to steroids used alongside these drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is confirmed without being a small cell type.

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My cancer has spread, as shown by bone scan or CT/MRI.

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I have prostate cancer, received 1-2 taxane treatments, and my cancer progressed during/after treatment.

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I am on hormone therapy for cancer, and my testosterone levels are low.

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I have either been treated with PARPi, was not eligible for it, or refused it.

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I have either received 177Lu-PSMA-617 treatment, was considered ineligible for it, or refused it.

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I have provided a fresh biopsy sample from a part of my body that hasn't been treated with radiation.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My condition worsened after treatment with a new hormone therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~54 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~54 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~54 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

OS in AR LBD Mutation-Negative Participants

Overall Survival (OS) in Androgen Receptor Ligand Binding Domain (AR LBD) Mutation-Positive Participants

Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review in AR LBD Mutation-Positive Participant

+1 more

Secondary study objectives

Duration of Response (DOR)

Number of Participants Who Discontinue Study Treatment Due to an Adverse Event

Number of Participants Who Experience an Adverse Event

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: OpevesostatExperimental Treatment4 Interventions

Participants receive opevesostat 5 mg by oral tablets twice daily (bid) plus dexamethasone 1.5 mg by oral tablets once daily (qd) and 0.1 mg fludrocortisone acetate by oral tablet qd until progression. Hydrocortisone 100 mg (oral or intramuscular \[IM\]) dose will also be provided to participants for use as rescue medication.

Group II: Abiraterone Acetate or EnzalutamideActive Control3 Interventions

Participants receive abiraterone 1000 mg qd by oral tablets plus prednisone 5 mg bid by oral tablets or enzalutamide 160 mg qd by oral tablets.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludrocortisone acetate

2024

Completed Phase 1

~20

Hydrocortisone

2005