NCT07287150

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

A Phase II, Randomized, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of the Combination of Inavolisib Plus Enzalutamide Versus Physician's Choice of ARPI or Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Metastatic Castration-Resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Inavolisib	Inavolisib will be administered orally as per the schedule specified in the protocol.
DRUG	Enzalutamide	Enzalutamide will be administered orally as per the schedule specified in the protocol.
DRUG	Abiraterone	Abiraterone will be administered orally as per the schedule specified in the protocol.
DRUG	Docetaxel	Docetaxel will be administered intravenously as per the schedule specified in the protocol.

Timeline

• Start date: 2026-03-11
• Primary completion: 2028-03-31
• Completion: 2029-07-30
• First posted: 2025-12-17
• Last updated: 2026-04-08

Locations

13 sites across 5 countries: United States, Australia, Brazil, Canada, South Korea

Regulatory

• FDA-regulated drug study