RecruitingPhase 1NCT05938270

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

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)


Sponsor

AstraZeneca

Enrollment

120 participants

Start Date

Sep 21, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of two drugs — saruparib (AZD5305, a PARP inhibitor that targets DNA repair) and darolutamide (a hormone-blocking drug) — can shrink prostate cancer tumors before surgery, and studying how the drugs affect the tumor biology. **You may be eligible if...** - You are male and at least 18 years old - You have localized prostate cancer that is classified as unfavourable intermediate, high, or very high risk - You are considered a good candidate for prostate removal surgery (radical prostatectomy) - Your organs are functioning well enough for treatment **You may NOT be eligible if...** - You have already received treatment for prostate cancer - You have metastatic (spread) prostate cancer - You have significant other health conditions that would make the surgery or treatment unsafe - You are taking medications that interact with the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSaruparib (AZD5305)

Saruparib (AZD5305) given orally once daily

DRUGDarolutamide

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

OTHERNo 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

View Full Details on ClinicalTrials.gov

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NCT05938270


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