AZD5305 vs Placebo in Men with Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents - EvoPAR-PR01

Study identifier:D9723C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:2023-504214-30-00

Will Be Recruiting

Official Title

A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of AZD5305 in Combination with Physician’s Choice New Hormonal Agents in Patients with HRRm and non-HRRm Metastatic Castration‑Sensitive Prostate Cancer (EvoPAR-Prostate01)

Medical condition

Metastatic Castration-Sensitive Prostate Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

AZD5305, Placebo, Abiraterone Acetate, Darolutamide, Enzalutamide

Sex

Male

Estimated Enrollment

1800

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 24 Nov 2023
Estimated Primary Completion Date: 14 Jan 2028
Estimated Study Completion Date: 28 Apr 2031

Study design

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

Verification:

Verified 01 Oct 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria