NCT05938270

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-21
• Primary completion: 2026-08-17
• Completion: 2026-08-17
• First posted: 2023-07-10
• Last updated: 2026-02-24

Locations

19 sites across 7 countries: United States, Australia, Canada, Netherlands, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study