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), Olaparib (drug), Docetaxel (drug), Cabazitaxel (drug)
- How long the study runs
- Study runs about 56 months (dates as stated)
- About the drug or intervention
- Opevesostat — drug: Oral Tablet · Olaparib — drug: Oral Tablet · Docetaxel — drug: IV Infusion · Cabazitaxel — drug: IV Infusion · Fludrocortisone acetate — drug: Oral Tablet · Dexamethasone — drug: Oral Tablet · Prednisone — drug: Oral Tablet
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 220
- Started
- 2024-05-20
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for prostatic neoplasms, castration-resistant
- • Phase1/Phase2 - 220 participants
- • Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with prostatic neoplasms, castration-resistant
Where?
- • Cambridge - Addenbrooke's Hospital ( Site 1902)
- • Glasgow - The Beatson West of Scotland Cancer Centre ( Site 1904)
- • Preston - Royal Preston Hospital-Lancashire Clinical Research Facility ( Site 1900)
- • London - University College London Hospital ( Site 1905)
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01). The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC. This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study.
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:
- ✓ 1 to 2 novel h
- ✓ been on stable doses for \>4 weeks
- ✓ recovered to \<Grade 1 or baseline
- ✓ well controlled HIV on antiretroviral therapy
What the study is looking for
- ✓The main inclusion criteria include but are not limited to the following:
- ✓confirmed by testing a sample diagnosis of adenocarcinoma of the prostate without small cell histology.
- ✓Prostate cancer progression and received androgen deprivation therapy (ADT) or post bilateral orchiectomy within 6...
- ✓Current evidence of that has spread disease.
- ✓Treatment with bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been...
Who cannot take part
- ✗The main exclusion criteria include but are not limited to the following:
- ✗History of pituitary dysfunction.
- ✗Poorly controlled diabetes mellitus.
- ✗History or family history of long corrected QT interval (QTc) syndrome.
- ✗Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or features suggestive of MDS/AML.
See the full criteria
Where Is This Study? (5 UK sites)
Addenbrooke's Hospital ( Site 1902)
Cambridge CB2 2QQ, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 1904)
Glasgow G12 0YN, United Kingdom
Royal Preston Hospital-Lancashire Clinical Research Facility ( Site 1900)
Preston PR2 9HT, United Kingdom
University College London Hospital ( Site 1905)
London NW1 2PG, United Kingdom
Queen Elizabeth Hospital Birmingham ( Site 1903)
Birmingham B15 2TH, United Kingdom
How to Get in Touch
Toll Free Number
Sponsor contactCONTACT
