Actively Recruiting
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Led by Hoffmann-La Roche · Updated on 2026-05-06
100
Participants Needed
20
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed adenocarcinoma of the prostate without small-cell or neuroendocrine features
- Progressive metastatic castration-resistant prostate cancer defined by PSA progression, soft tissue disease progression, or bone disease progression
- Treatment with exactly one prior second-generation androgen receptor pathway inhibitor (abiraterone, apalutamide, enzalutamide, or darolutamide) for hormone-sensitive or castration-resistant prostate cancer
- Availability of suitable tumor tissue specimen for biomarker testing
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Fasting glucose less than 100 mg/dL and HbA1c less than 5.7%
You will not qualify if you...
- Presence of liver metastasis
- Prior treatment with any PI3K, AKT, or mTOR inhibitor or any agent targeting the PI3K/AKT/mTOR pathway
- Type 1 or Type 2 diabetes mellitus
- Prior treatment for metastatic castration-resistant prostate cancer with cytotoxic chemotherapy or novel hormonal treatments except specified permitted therapies
- Use of other concurrent anti-cancer therapies except androgen deprivation therapy
- Treatment with strong CYP2C8 inhibitors or inducers or strong CYP3A4 inducers within one week or five drug half-lives before starting study treatment
- Blood transfusion solely to become eligible or within 28 days before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
UCSF
San Francisco, California, United States, 94115
Actively Recruiting
2
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242-1009
Actively Recruiting
3
Montefiore Einstein Cancer Center
The Bronx, New York, United States, 10461
Actively Recruiting
4
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572-4607
Actively Recruiting
5
Sunshine Coast University Hospital
Birtinya, Queensland, Australia, 4575
Actively Recruiting
6
Royal Brisbane & Womens Hospital
Herston, Queensland, Australia, 4006
Actively Recruiting
7
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Actively Recruiting
8
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
Actively Recruiting
9
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo André, São Paulo, Brazil, 09060-650
Actively Recruiting
10
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
11
Centre de recherche du Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
12
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
13
Centre Léon Bérard
Lyon, France, 69008
Actively Recruiting
14
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, South Korea, 13620
Actively Recruiting
15
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
16
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
17
Asan Medical Center.
Seoul, South Korea, 05505
Actively Recruiting
18
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
19
C.H. Regional Reina Sofia - PPDS
Córdoba, Spain, 14004
Actively Recruiting
20
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
Research Team
R
Reference Study ID Number: CO45813 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here