At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Saruparib (AZD5305) (drug), Darolutamide (drug), No Treatment (other)
- How long the study runs
- Study runs about 33 months (dates as stated)
- About the drug or intervention
- Saruparib (AZD5305) — drug: Saruparib (AZD5305) given orally once daily · Darolutamide — drug: Darolutamide tablet is 300mg, given BD orally, twice daily- total dose 1200mg · No Treatment — other: No study treatment is to be taken by the participants in this arm.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Male
- Number of participants
- 113
- Started
- 2023-09-21
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for prostate cancer
- • Phase1 - 113 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with prostate cancer
- • Male only
Where?
- • Cambridge - Research Site
- • Manchester - Research Site
- • Newcastle upon Tyne - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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).
More detail
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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Male only
Biomarkers mentioned
What the study is looking for
- ✓male participants \>/= 18 years old
- ✓participants deemed suitable for radical prostatectomy
- ✓participants with localised prostate cancer with unfavourable intermediate/high/very high risk eligible for...
- ✓adequate organ and marrow function as per protocol
- ✓capable of giving signed agreement to take part
Who cannot take part
- ✗Active HBV is defined by a known positive HBsAg result. Participants with a past or resolved HBV infection (defined...
- ✗Participants positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
- ✗Participants with any known predisposition to bleeding (eg, active peptic ulceration, recent \[within 6 months\]...
- ✗Prior cancer within 3 years of screening whose natural history, in the Investigator's opinion, has the potential...
- ✗Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of TdP.
See the full criteria
Where Is This Study? (3 UK sites)
Research Site
Cambridge CB2 0QQ, United Kingdom
Research Site
Manchester M20 4BX, United Kingdom
Research Site
Newcastle upon Tyne NE7 7AF, United Kingdom
