FindTrial
Sign In

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
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521327-67-00
Enrollment
8
Registered
2026-03-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Castration-Resistant Prostate Cancer

Brief summary

Radiographic Progression-Free Survival (rPFS)

Detailed description

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

Interventions

DRUGINAVOLISIB
DRUGDOCETAXEL
DRUGABIRATERONE
DRUGENZALUTAMIDE

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Radiographic Progression-Free Survival (rPFS)—

Secondary

MeasureTime frame
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—

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 7, 2026