RecruitingPhase 2NCT07287150

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


Sponsor

Hoffmann-La Roche

Enrollment

100 participants

Start Date

Mar 11, 2026

Study Type

INTERVENTIONAL

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called inavolisib in men with advanced prostate cancer that has stopped responding to hormone therapy (called metastatic castration-resistant prostate cancer, or mCRPC). **You may be eligible if...** - You have confirmed prostate cancer that has spread and stopped responding to hormone-lowering therapy - Your cancer is progressing based on rising PSA levels, new bone lesions on a scan, or measurable tumor growth - You have received at least one but no more than two prior hormonal therapies (ARPI) - Your overall health and organ function are adequate **You may NOT be eligible if...** - Your prostate cancer has neuroendocrine or small-cell features - You have received more than two prior hormonal therapies - You have untreated brain metastases or other serious conditions - Your organ function does not meet the study's minimum requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInavolisib

Inavolisib will be administered orally as per the schedule specified in the protocol.

DRUGEnzalutamide

Enzalutamide will be administered orally as per the schedule specified in the protocol.

DRUGAbiraterone

Abiraterone will be administered orally as per the schedule specified in the protocol.

DRUGDocetaxel

Docetaxel will be administered intravenously as per the schedule specified in the protocol.


Locations(13)

UCSF

San Francisco, California, United States

Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Montefiore Einstein Cancer Center

The Bronx, New York, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

Santo André, São Paulo, Brazil

Jewish General Hospital

Montreal, Quebec, Canada

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggido, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center.

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT07287150