Trial comparing treatments for Metastatic Castration-resistant Prostate Cancer (mCRPC)
Official title 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 ID: NCT06136650
What this study is testing
What is Opevesostat?
Opevesostat is an investigational oral medicine being studied for metastatic castration‑resistant prostate cancer.
Also referred to as MK-5684.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if opevesostat is safer and more effective than the other drugs, especially in terms of overall survival, for patients with or without a specific gene mutation.
- Who it's for
- Men with metastatic castration‑resistant prostate cancer who have already received one next‑generation hormonal agent.
- What's involved
- Participants will receive either opevesostat with daily steroids or an alternative drug (abiraterone or enzalutamide). They will have regular clinic visits and medical tests to monitor safety and effectiveness.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
- Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening
- Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease shown by...
- Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC)...
- Has had prior treatment with poly (ADP-ribose) polymerase inhibitor (PARPi) or were deemed ineligible to receive treatment by the investigator or...
You likely can't join if
- Has presence of gastrointestinal condition
- Is unable to swallow capsules/tablets
- Has history of pituitary dysfunction
- Has poorly controlled diabetes mellitus
- Has clinically significant abnormal serum potassium or sodium level
- Has any of the following at screening visit: Hypotension: systolic blood pressure (BP) \<110 mmHg, or uncontrolled hypertension: systolic BP ≥160mmHg...
See the full eligibility criteria
Who can join
- Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
- Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening
- Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography (CT)/magnetic resonance imaging (MRI)
- Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) (metastatic hormone-sensitive prostate cancer [mHSPC] or non-metastatic...
- Has had prior treatment with poly (ADP-ribose) polymerase inhibitor (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
- Has ongoing androgen deprivation therapy (ADT) with serum testosterone \<50 ng/dL (\<1.7 nM)
- Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 10 days before randomization
- Has adequate organ function
- Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before...
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- Participants who have adverse event (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
What rules you out
- Has presence of gastrointestinal condition
- Is unable to swallow capsules/tablets
- Has history of pituitary dysfunction
- Has poorly controlled diabetes mellitus
- Has clinically significant abnormal serum potassium or sodium level
- Has any of the following at screening visit: Hypotension: systolic blood pressure (BP) \<110 mmHg, or uncontrolled hypertension: systolic BP ≥160mmHg or diastolic blood BP ≥90 mmHg, in 2 out of the 3 recordings with...
- Has a history of active or unstable cardio/cerebrovascular disease, including thromboembolic events
- History or family history of long QTc syndrome
- Has a history of seizure(s) within 6 months before providing documented informed consent (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollment
- Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place
- Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC)
- Has not adequately recovered from major surgery or have ongoing surgical complications
- Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures
- Participants on an unstable dose of thyroid hormone therapy, as judged by the investigator, within 6 months before the start of the study intervention
- Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids
- Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
- Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention
- Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat
- Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not...
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose...
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without...
- Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed
- Active infection requiring systemic therapy
- Has concurrent active Hepatitis B virus and Hepatitis C virus infection
The study team makes the final eligibility decision.
Where it is enrolling
- Tucson, Arizona, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Riverside, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Highlands Ranch, Colorado, United States
- Lakewood, Colorado, United States
- Lone Tree, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Miami Beach, Florida, United States
- Pembroke Pines, Florida, United States
- Atlanta, Georgia, United States
- Peoria, Illinois, United States
- Carmel, Indiana, United States
- Baltimore, Maryland, United States
+ 229 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tucson, Arizona, United States; Irvine, California, United States; Los Angeles, California, United States; Orange, California, United States; Palo Alto, California, United States; Riverside, California, United States and 243 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.