Actively Recruiting
A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.
Led by AstraZeneca · Updated on 2026-02-24
120
Participants Needed
19
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 years or older
- Suitable for radical prostatectomy
- Localized prostate cancer with unfavorable intermediate, high, or very high risk eligible for prostatectomy
- Adequate organ and marrow function as defined by the protocol
- Able to provide signed informed consent
- For optional genetic research, signed and dated consent provided
- Available formalin-fixed paraffin-embedded (FFPE) diagnostic tumor biopsy samples
- Agree to use condoms with spermicide from screening until 6 months after and not father a child or donate sperm during this period
You will not qualify if you...
- Severe or uncontrolled systemic diseases, including active bleeding disorders or infections such as active hepatitis B, hepatitis C with detectable RNA, or HIV
- Known bleeding predisposition, including active peptic ulcers or recent hemorrhagic stroke
- History or features suggestive of myelodysplastic syndrome or acute myeloid leukemia
- Prior malignancy within 3 years that could interfere with safety or efficacy assessments
- Use of drugs that prolong or shorten the QT interval or risk of torsades de pointes
- Abnormal QT intervals or heart rhythm abnormalities as defined by ECG criteria
- Significant cardiovascular diseases including symptomatic heart failure, uncontrolled hypertension, or recent acute coronary events within 6 months
- Chronic gastrointestinal conditions preventing absorption of Saruparib
- Prior systemic or localized anti-cancer treatment for localized prostate cancer
- Use of immune modulatory agents, including corticosteroids >10 mg prednisone daily within 4 weeks before first dose
- Use of strong CYP3A4 or P-glycoprotein inducers/inhibitors not discontinued at least 21 days before first dose until 30 days after last dose
- Treatment with investigational agents within 5 half-lives or 3 weeks before first dose
- Contraindication to darolutamide for treatment arms
- Inability to comply with study visits and assessments
- Investigator's discretion to exclude participants
- For no treatment arm only: exclusion if meeting specific cardiac or gastrointestinal criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Research Site
Detroit, Michigan, United States, 48202
Actively Recruiting
2
Research Site
Providence, Rhode Island, United States, 02903
Actively Recruiting
3
Research Site
Melbourne, Australia, VIC 3000
Actively Recruiting
4
Research Site
South Brisbane, Australia, 4101
Actively Recruiting
5
Research Site
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
6
Research Site
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
7
Research Site
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
8
Research Site
Amsterdam, Netherlands, 1066CX
Actively Recruiting
9
Research Site
Nijmegen, Netherlands, 6525 GA
Actively Recruiting
10
Research Site
Barcelona, Spain, 08036
Actively Recruiting
11
Research Site
Barcelona, Spain, 8035
Actively Recruiting
12
Research Site
Madrid, Spain, 28041
Actively Recruiting
13
Research Site
Valencia, Spain, 46009
Actively Recruiting
14
Research Site
Ankara, Turkey (Türkiye), 06100
Withdrawn
15
Research Site
Ankara, Turkey (Türkiye), 6200
Withdrawn
16
Research Site
Istanbul, Turkey (Türkiye), 34010
Withdrawn
17
Research Site
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
18
Research Site
Manchester, United Kingdom, M20 4BX
Actively Recruiting
19
Research Site
Newcastle upon Tyne, United Kingdom, NE7 7AF
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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