MedTrace Logo

Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

NCT06120491 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2026-04-03

No results posted yet for this study

Summary

The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.

Conditions

  • Metastatic Castration-Sensitive Prostate Cancer

Interventions

DRUG

Saruparib

Oral

DRUG

Placebo

Oral

DRUG

Abiraterone Acetate

Oral

DRUG

Darolutamide

Oral

DRUG

Enzalutamide

Oral

Sponsors & Collaborators

Principal Investigators

  • Kim Nguyen Chi, MD · BC Cancer, Canada

  • Arun Azad, MD · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-21
Primary Completion
2028-01-11
Completion
2031-04-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Finland
  • France
  • Germany
  • Hungary
  • India
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • Peru
  • Poland
  • Puerto Rico
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06120491 on ClinicalTrials.gov