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RECRUITING
NCT05938270
PHASE1

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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).

Official title: An Open-label, Randomised, Phase-I, Multi-Centre 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)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-09-21

Completion Date

2026-08-17

Last Updated

2026-02-24

Healthy Volunteers

No

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

Locations (19)

Research Site

Detroit, Michigan, United States

Research Site

Providence, Rhode Island, United States

Research Site

Melbourne, Australia

Research Site

South Brisbane, Australia

Research Site

Vancouver, British Columbia, Canada

Research Site

Toronto, Ontario, Canada

Research Site

Québec, Quebec, Canada

Research Site

Amsterdam, Netherlands

Research Site

Nijmegen, Netherlands

Research Site

Barcelona, Spain

Research Site

Barcelona, Spain

Research Site

Madrid, Spain

Research Site

Valencia, Spain

Research Site

Ankara, Turkey (Türkiye)

Research Site

Ankara, Turkey (Türkiye)

Research Site

Istanbul, Turkey (Türkiye)

Research Site

Cambridge, United Kingdom

Research Site

Manchester, United Kingdom

Research Site

Newcastle upon Tyne, United Kingdom