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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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

Hydrocortisone

2005

Completed Phase 4

~1260

Dexamethasone

2007

Completed Phase 4

~2590

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Orion Corporation, Orion PharmaIndustry Sponsor

137 Previous Clinical Trials

43,724 Total Patients Enrolled

5 Trials studying Prostate Cancer

407 Patients Enrolled for Prostate Cancer

Merck Sharp & Dohme LLCLead Sponsor

3,892 Previous Clinical Trials

5,059,946 Total Patients Enrolled

27 Trials studying Prostate Cancer

16,997 Patients Enrolled for Prostate Cancer

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,204 Total Patients Enrolled

13 Trials studying Prostate Cancer

3,306 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current total number of participants being recruited for this clinical study?

"Indeed, as documented on clinicaltrials.gov, this trial is currently in the active recruitment phase. The initial posting of the study occurred on December 31st, 2023 and it was most recently updated on January 5th, 2024. In order to complete the trial successfully, a total of 1200 participants will be enrolled across six different locations."

Answered by AI

Is the current investigation open for participant enrollment?

"Indeed, the details provided on clinicaltrials.gov indicate that this trial is currently seeking participants. The initial posting of the clinical trial was made on December 31st, 2023 and it was last updated on January 5th, 2024. The study aims to enroll a total of 1200 patients across six distinct locations."

Answered by AI

Has MK-5684 received the official stamp of approval from the FDA?

"Based on the classification of this trial as Phase 3, our team at Power assigns a safety rating of 3 to MK-5684. This indicates that there is evidence supporting its efficacy, along with multiple rounds of data demonstrating its safety."

Answered by AI

At how many distinct venues is this medical trial currently being conducted?

"In addition to Ad-Vance Medical Research-Research (Site 1353) in Ponce, Pan American Center for Oncology Trials - Ciudadela (Site 1351) in San Juan, and Blue Ridge Cancer Care (Site 0004) in Roanoke, there are six more sites involved in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

2023. "Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06136624.

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