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
- Inavolisib (drug), Enzalutamide (drug), Abiraterone (drug), Docetaxel (drug)
- How long the study runs
- Study runs about 40 months (dates as stated)
- About the drug or intervention
- Inavolisib — drug: Inavolisib will be administered orally as per the schedule specified in the protocol. · Enzalutamide — drug: Enzalutamide will be administered orally as per the schedule specified in the protocol. · Abiraterone — drug: Abiraterone will be administered orally as per the schedule specified in the protocol. · Docetaxel — drug: Docetaxel will be administered intravenously as per the schedule specified in the protocol.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Male
- Number of participants
- 100
- Started
- 2026-03-11
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for metastatic castration-resistant prostate cancer
- • Phase2 - 100 participants
- • This study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with metastatic castration-resistant prostate cancer
- • Male only
Where?
- • Sutton - The Royal Marsden in Sutton, Surrey - Downs Rd
- • Cardiff - Velindre Cancer Centre
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi.
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: Male only
Biomarkers mentioned
What the study is looking for
- ✓confirmed by testing a sample adenocarcinoma of the prostate without small-cell or neuroendocrine features
- ✓Treatment with at least one, but no more than one, prior second-generation ARPi (abiraterone, apalutamide,...
- ✓Availability of a tumor tissue specimen that is suitable (e.g., adequate quality and quantity) for use in...
- ✓activity scale (ECOG) Performance Status of 0 or 1
- ✓Fasting glucose \<126 mg/dL and HbA1c \< 6%
Who cannot take part
- ✗Presence of liver metastasis
- ✗Type 1 or Type 2 diabetes mellitus
- ✗Other concurrent anti-cancer therapy except for androgen deprivation therapy
- ✗Transfusion of any blood product for the sole purpose of making a potential participant eligible for study inclusion...
See the full criteria
Where Is This Study? (2 UK sites)
The Royal Marsden in Sutton, Surrey - Downs Rd
Sutton SM2 5PT, United Kingdom
Velindre Cancer Centre
Cardiff CF14 2TL, United Kingdom
How to Get in Touch
Reference Study ID Number: CO45813 https://forpatients.roche.com/ No attachments to email below.
Sponsor contactCONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Sponsor contactCONTACT
