Background Information
Metastatic castration-resistant prostate cancer (mCRPC) is a form of prostate cancer that keeps growing even when male hormones like testosterone are decreased to very low levels. Current treatments include drugs that block these hormones, chemotherapy, and hormone therapies. However, these treatments can stop working overtime.
This clinical trial aims to test the safety and effectiveness of an investigational drug called MK-5684 to see if it may help stop or slow the spread of prostate cancer, specifically mCRPC. The study will look at how well MK-5684 may work alone and in combination with other drugs that are used to treat different types of mCRPC. MK-5684 is experimental as is the combination of MK-5684 with any of these drugs.
Study Details
What is the Purpose?
This study is a randomized, open-label trial conducted in multiple centers to find out if the investigational drug, MK-5684, is safe and may help to slow down or stop the growth of mCRPC. This study will compare: MK-5684 alone or with other standard treatments that patients receive after their cancer has progressed despite previous therapies.
About The Investigational Drug
The investigational drug, MK-5684, is a pill taken by mouth. Researchers are evaluating if the investigational drug can block an enzyme called CYP11A1 and reduce the production of steroid hormones. By reducing steroid hormones, including those that help prostate cancer grow, we are trying to see if the investigational drug will help stop or slow the spread of prostate cancer. The length of time patients take MK-5684 will depend on their response and how well they tolerate the study drugs.
Who Can Participate?
Inclusion Criteria*
- Men aged 18 years and older.
- Diagnosed with mCRPC that has worsened despite hormone therapy.
- No previous treatment with CYP11A1 inhibitors.
Key Exclusion Criteria*
- History of other cancers in the last 3 years (except for some skin cancers or early-stage cancers that have been cured).
- Major surgery or localized radiation therapy within 14 days before joining the trial.
- Significant heart, kidney, or liver disease.
*Additional eligibility criteria apply.
What’s Involved?
Participants will receive:
- The investigational drug, MK-5684, alone or in combination with 1 of 3 other drugs that are used to treat different types of mCRPC: olaparib, docetaxel, or cabazitaxel. Participants will be placed in one of these four groups.
- Group 1 will get MK-5684 only.
- Group 2 will get MK-5684 in combination with olaparib.
- Group 3 will get MK-5684 in combination with docetaxel.
- Group 4 will get MK-5684 in combination with cabazitaxel
The study doctor will discuss the possible risks and benefits of participating and you will have the opportunity to ask questions.
What to Expect
- Taking the investigational drug, MK-5684: Tablets taken by mouth twice daily.
- Visit Schedule: Regular visits to check how the patient is responding to the study treatments and manage any side effects.
- Study Timeline:
- Screening Period: Up to 42 days to check eligibility.
- Treatment Period: Until the disease worsens or side effects become too severe.
- Safety Follow-Up: At least 30 days after the last dose.
- Long-Term Follow-Up: Periodic check-ups to monitor overall health and cancer status.
Participation Length
- The length of participation depends on how the patient responds to the study drug, how well they tolerate the study drug, and their personal choice. Patients can continue taking the study drug until the disease progresses, or side effects become too severe. They may stay in the study if it is beneficial or until the trial ends.
Organization:
Merck
Clinicaltrials.gov Information:
- NCT Number: NCT06353386
- Title: Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)
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.
