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Hormone Therapy

hormone replacement therapy (HRT)+ 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 an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization
Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 82 months
Awards & highlights

Study Summary

This trial is studying the effectiveness and safety of MK-5684 plus hormone replacement therapy compared to other treatments in men with advanced prostate cancer. The main goal of the study is to see if MK-

Who is the study for?
This trial is for men with advanced prostate cancer that has spread and worsened despite hormone therapy. They must have tried one hormonal drug already, be in good physical shape (able to perform daily activities), and have normal organ function. Men who've had small cell prostate cancer or more than six cycles of a specific chemotherapy aren't eligible.Check my eligibility
What is being tested?
The study compares MK-5684 plus hormone replacement against other drugs like abiraterone acetate or enzalutamide in controlling advanced prostate cancer. It measures how long patients live without their disease getting worse on scans and overall survival, especially focusing on those with certain genetic features of the cancer.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, skin rash, changes in blood pressure due to hormone treatments, liver function changes from MK-5684, and potential allergic reactions to any of the medications used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My prostate cancer is confirmed and not of the small cell type.
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My scans show cancer has spread to my bones or other parts of my body.
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I have either been treated with PARPi, was considered not suitable for it, or I refused PARPi treatment.
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My testosterone levels are below 50 ng/dL due to ongoing treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 82 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 82 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
Overall Survival (OS)
Radiographic Progression-free Survival (rPFS)
Secondary outcome measures
Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Total Score
Duration of Response (DOR)
Number of Participants Who Discontinue Study Treatment Due to an AE
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: hormone replacement therapy (HRT)+ opevesostatExperimental Treatment4 Interventions
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.
Group II: Alternative next generation hormonal agent (NHA)Active 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 until disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Hydrocortisone
2005
Completed Phase 4
~1280

Find a Location

Who is running the clinical trial?

Orion Corporation, Orion PharmaIndustry Sponsor
137 Previous Clinical Trials
43,424 Total Patients Enrolled
5 Trials studying Prostate Cancer
407 Patients Enrolled for Prostate Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,896 Previous Clinical Trials
5,061,219 Total Patients Enrolled
27 Trials studying Prostate Cancer
16,997 Patients Enrolled for Prostate Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,782 Previous Clinical Trials
8,064,816 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.

Are patients currently able to participate in this ongoing trial?

"Indeed, as stated on clinicaltrials.gov, this study is presently seeking eligible participants. The trial was initially posted on December 18th, 2023 and recently updated on December 27th, 2023."

Answered by AI

At present, how many locations are hosting this particular clinical trial?

"This clinical trial is actively seeking participants from a total of 5 sites, including locations in Las Vegas, Roanoke, and Billings. It is advised to choose the site closest to your location in order to minimize travel obligations if you decide to participate."

Answered by AI

What are the potential hazards associated with combining MK-5684 and hormone replacement therapy (HRT) in individuals?

"Due to the availability of both efficacy and safety data from multiple rounds, our team at Power rates the safety level of MK-5684 + hormone replacement therapy (HRT) as 3 on a scale ranging from 1 to 3. This rating aligns with the trial's Phase 3 status."

Answered by AI

What is the current number of individuals actively involved in this medical study?

"Indeed, the details provided on clinicaltrials.gov indicate that this investigation is actively searching for eligible participants. The initial posting of the study took place on December 18th, 2023 and it was most recently updated on December 27th, 2023. A total of 1500 patients are being sought from five different locations to participate in this trial."

Answered by AI

Who else is applying?

What site did they apply to?
OptumCare Cancer Care-Research Department ( Site 0078)
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Curious of alternate/advanced treatment.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
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)
2023. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06136650.
All > Prostate Cancer Las Vegas > Abiraterone Acetate
~1000 spots leftby Dec 2030
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