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Clinical Trials in the EU / 2025-521327-67-00
Authorised, recruiting Phase II

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

2025-521327-67-00 · tracked via the Priya Life Science EU tracker
Sponsor
F. Hoffmann-La Roche AG
Sponsor type
Pharmaceutical company
Therapeutic area
Neoplasms
Decision date
06/03/2026
Enrollment target
32
Sites
Germany, France, Italy, Spain

Condition studied

Metastatic Castration-Resistant Prostate Cancer

Investigational medicinal product(s)

ABIRATERONEDOCETAXELENZALUTAMIDEINAVOLISIB

Eligibility

Age group
65+ years, 18-64 years
Sex
Male

Primary endpoint

Radiographic Progression-Free Survival (rPFS)

Endpoint detail

Confirmed Composite Response Rate (RR), Confirmed prostate-specific antigen 90 (PSA90), Confirmed prostate-specific antigen 50 (PSA50), Objective Response Rate (ORR), Duration of Response (DOR), Overall Survival (OS), Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0), Change from baseline in selected vital signs, Change from baseline in selected clinical laboratory test results

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-521327-67-00 on CTIS ↗ ← All trials in the EU