This clinical trial is for participants who have metastatic castration-resistant prostate cancer (mCRPC) and failed to respond to drugs or surgery to block the testes from making hormones and after treatment with other drugs for prostate cancer.
Study of Investigational Drug, MK5684, in Participants with Metastatic Castration-Resistant Prostate Cancer
Patient Summary
The Omaha-003 clinical trial is for participants who have metastatic castration-resistant prostate cancer (mCRPC) and failed to respond to drugs or surgery to block the testes from making hormones and after treatment with other drugs for prostate cancer.
This trial is comparing the investigational drug, MK5684, to standard treatments for mCRPC. Researchers want to learn if the investigational study drug, MK-5684, when taken with 2 hormone replacement drugs, is safe, how well it may work, and if participants live longer or live longer before their disease worsens compared to those who take abiraterone acetate or enzalutamide (standard treatments for mCRPC).
This is a Phase 3 clinical trial that will enroll approximately 1,200 participants.
What is the Purpose?
This clinical trial’s objective is to find out if MK-5684 is safe and if it may help to slow down or stop the growth of mCRPC.
What Type of Therapy is being studied?
The investigational drug, MK-5684, is being studied to see whether it may help slow or stop prostate cancer by blocking a protein in the body called CYP11A1 from making androgens and other steroid hormones. Many proteins in the body help make androgens. Androgens are a type of steroid hormone that certain types of prostate cancer cells can use to grow and spread. MK-5684 is experimental. It has not been approved to treat any disease or condition.
Who Can Participate?
You may qualify to take part in this trial if you:
- Are ≥18 years of age
- Have advanced mCRPC (Stage 4 metastatic prostate cancer)
- Your mCRPC has become worse within 6 months before starting the trial and:
- After being treated with drugs or surgery to block the testes from making hormones
AND
- After treatment with other drugs for prostate cancer
You may not qualify to take part in this trial if you:
- Have a gastrointestinal disorder that might affect absorption of the study medication
- Have a history of pituitary dysfunction
- Have poorly controlled diabetes mellitus
These are not the only eligibility criteria. For further information, please speak to the trial doctor.
What’s Involved?
In this trial, participants will receive:
- The investigational drug, MK-5684, plus hormone replacement therapy (fludrocortisone and dexamethasone)
OR
- One of the standard treatments, abiraterone acetate or enzalutamide. Abiraterone acetate can cause the adrenal glands to make less of a hormone called cortisol. To help maintain this hormone, participants in this group who get abiraterone acetate will also get a steroid drug called prednisone or prednisolone to help with this.
The study doctor will discuss the possible risks and benefits of participating and you will have the opportunity to ask questions.
Organization:
Clinicaltrials.gov Information:
- NCT Number: NCT06136624
- Title: Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Use the “clinical trials glossary” and “dictionary” for words, phrases and treatments that you may not understand.
Register your interest or comments about this trial with PHEN
Please Note: This information is provided for educational and awareness purposes. A decision on clinical trials participation is to be made between the patient and his doctor.
