A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT07287150
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 11, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2028
Completion
Jul 30, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Participants will receive Inavolisib plus enzalutamide
  • Active Comparator: Arm 2
    Participants will receive either ARPi switch (enzalutamide or abiraterone) or docetaxel

Primary Outcome Measure

Radiographic Progression-free Survival (rPFS) [ Time Frame: Up to approximately 5 years ]

Central Contacts

  • Reference Study ID Number: CO45813 https://forpatients.roche.com/
    888-662-6728 (U.S. and Canada)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (5)

FacilityCityStateZIPSite coordinators
UCSFSan FranciscoCalifornia94115-
Holden Comprehensive Cancer CenterIowa CityIowa52242-1009-
Montefiore Einstein Cancer CenterThe BronxNew York10461-
Lifespan Cancer InstituteProvidenceRhode Island02903-4923-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-4607-

Find similar trials in San Francisco, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
UCSF· San Francisco, CAHolden Comprehensive Cancer Center· Iowa City, IAMontefiore Einstein Cancer Center· The Bronx, NYLifespan Cancer Institute· Providence, RICarolina Urologic Research Center· Myrtle Beach, SC

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