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), Dexamethasone (drug), Fludrocortisone acetate (drug), Hydrocortisone (drug)
- How long the study runs
- Study runs about 84 months (dates as stated)
- About the drug or intervention
- Opevesostat — drug: Administered orally · Dexamethasone — drug: Administered orally · Fludrocortisone acetate — drug: Administered orally · Hydrocortisone — drug: Administered orally or IM as a rescue drug · Abiraterone acetate — drug: Administered orally · Prednisone acetate — drug: Administered orally · Enzalutamide — drug: Administered orally
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,314
- Started
- 2023-12-18
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for metastatic castration-resistant prostate cancer (mcrpc)
- • Phase3 - 1,314 participants
- • The purpose of this study is to assess the efficacy and safety of opevesostat plus daily corticosteroids compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with metastatic castration-resistant prostate cancer (mcrpc)
Where?
- • Cambridge - Addenbrooke's Hospital ( Site 1426)
- • Derby - Royal Derby Hospital ( Site 1431)
- • Torquay - Torbay Hospital ( Site 1429)
- • Northwood - Mount Vernon Cancer Centre ( Site 1440)
- • +9 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to assess the efficacy and safety of opevesostat plus daily corticosteroids compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.
More detail
Per Protocol Amendment 08, OS was moved to be a secondary outcome measure. Per Protocol Amendment 11, OS was returned to a primary outcome measure.
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
Treatment history
Treatments you must have had:
- ✓ poly (ADP-ribose) polymerase inhibit
- ✓ recovered to ≤Grade 1 or baseline
- ✓ well controlled HIV on antiretroviral therapy (ART)
What the study is looking for
- ✓The main inclusion criteria include but are not limited to the following:
- ✓Have confirmed by testing a sample adenocarcinoma of the prostate without small cell histology
- ✓Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy)...
- ✓Has had prior treatment with poly (ADP-ribose) polymerase inhibitor (PARPi) or were deemed ineligible to receive...
- ✓Has ongoing androgen deprivation therapy (ADT) with serum testosterone \<50 ng/dL (\<1.7 nM)
Who cannot take part
- ✗The main exclusion criteria include but are not limited to the following:
- ✗Has presence of gastrointestinal condition
- ✗Is unable to swallow capsules/tablets
- ✗Has history of pituitary dysfunction
- ✗Has poorly controlled diabetes mellitus
See the full criteria
Where Is This Study? (13 UK sites)
Addenbrooke's Hospital ( Site 1426)
Cambridge CB2 2QQ, United Kingdom
Royal Derby Hospital ( Site 1431)
Derby DE22 3NE, United Kingdom
Torbay Hospital ( Site 1429)
Torquay TQ2 7AA, United Kingdom
Mount Vernon Cancer Centre ( Site 1440)
Northwood HA6 2RN, United Kingdom
The Royal Cornwall Hospital ( Site 1430)
Truro TR1 3LJ, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 1428)
Glasgow G12 0YN, United Kingdom
University College London Hospital ( Site 1437)
London NW1 2PG, United Kingdom
Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1435)
London SE1 9RT, United Kingdom
St. George's Hospital-Oncology ( Site 1441)
London SW17 0QT, United Kingdom
Charing Cross Hospital ( Site 1434)
London W6 8RF, United Kingdom
GenesisCare - Oxford ( Site 1442)
Oxford OX4 6LB, United Kingdom
GenesisCare - Windsor ( Site 1443)
Windsor SL4 3HD, United Kingdom
The Christie NHS Foundation Trust ( Site 1436)
Manchester m20 4bx, United Kingdom
How to Get in Touch
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