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A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.

NCT05938270 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-02-24

No results posted yet for this study

Summary

A Study to Investigate the Biological Effects of Saruparib (AZD5305) Alone, Darolutamide Alone, and in Combination Given Prior to Radical Prostatectomy in Men with Newly Diagnosed Prostate Cancer (ASCERTAIN).

Conditions

Interventions

DRUG

Saruparib (AZD5305)

Saruparib (AZD5305) given orally once daily

DRUG

Darolutamide

Darolutamide tablet is 300mg, given BD orally, twice daily- total dose 1200mg

OTHER

No Treatment

No study treatment is to be taken by the participants in this arm. Radical prostatectomy should be performed as per local practice

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-21
Primary Completion
2026-08-17
Completion
2026-08-17
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Netherlands
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT05938270 on ClinicalTrials.gov