At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Opevesostat (drug), Abiraterone acetate (drug), Enzalutamide (drug), Hydrocortisone (drug)
- How long the study runs
- Study runs about 74 months (dates as stated)
- About the drug or intervention
- Opevesostat — drug: Administered orally · Abiraterone acetate — drug: Administered orally · Enzalutamide — drug: Administered orally · Hydrocortisone — drug: Administered orally or IM as a rescue medication · Fludrocortisone acetate — drug: Administered orally · Prednisone — drug: Administered orally as a rescue medication · Dexamethasone — drug: Administered orally as rescue medication
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,310
- Started
- 2023-12-31
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for prostate cancer metastatic
- • Phase3 - 1,310 participants
- • This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) in participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with prostate cancer metastatic
Where?
- • Cambridge - Addenbrooke's Hospital ( Site 1605)
- • Truro - The Royal Cornwall Hospital ( Site 1610)
- • Glasgow - The Beatson West of Scotland Cancer Centre ( Site 1603)
- • London - Charing Cross Hospital-Oncology Research ( Site 1606)
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) in participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy. It is hypothesized that opevesostat is superior with respect to OS in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ PARPi
- ✓ been on stable doses for ≥ 4 weeks
- ✓ well controlled HIV on antiretroviral therapy (ART)
What the study is looking for
- ✓Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology.
- ✓Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6...
- ✓Has current evidence of distant that has spread disease (M1 disease) documented by either bone lesions on bone scan...
- ✓Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA)
- ✓Has received 1 but no more than 2 taxane-based drug treatment regimens for that has spread castration-resistant prostate...
Who cannot take part
- ✗Has a gastrointestinal disorder that might affect absorption
- ✗Has a history of pituitary dysfunction
- ✗Has poorly controlled diabetes mellitus
- ✗Has clinically significant abnormal serum potassium or sodium level
- ✗Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events
See the full criteria
Where Is This Study? (6 UK sites)
Addenbrooke's Hospital ( Site 1605)
Cambridge CB2 2QQ, United Kingdom
The Royal Cornwall Hospital ( Site 1610)
Truro TR1 3LJ, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 1603)
Glasgow G12 0YN, United Kingdom
Charing Cross Hospital-Oncology Research ( Site 1606)
London W6 8RF, United Kingdom
University College London Hospital ( Site 1612)
London NW1 2PG, United Kingdom
The Christie NHS Foundation Trust ( Site 1608)
Manchester m20 4bx, United Kingdom
How to Get in Touch
Toll Free Number
Sponsor contactCONTACT
