Capivasertib+Abiraterone as Treatment for Patients with Metastatic Hormone-sensitive Prostate Cancer and PTEN deficiency - CAPItello-281

Study identifier:D361BC00001

ClinicalTrials.gov identifier:NCT04493853

EudraCT identifier:2020-000346-33

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib+Abiraterone Versus Placebo+Abiraterone as Treatment for Patients with DeNovo Metastatic Hormone-Sensitive Prostate Cancer Characterised by PTEN deficiency.

Medical condition

Hormone-Sensitive Prostate Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Capivasertib, Abiraterone Acetate

Sex

Male

Actual Enrollment

1000

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 13 Jul 2020
Estimated Primary Completion Date: 30 Apr 2025
Estimated Study Completion Date: 26 Mar 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria