ASCERTAIN
Research type
Research Study
Full title
An Open-label, Randomised, Phase-I, Multi-Centre Study to Investigate the Biological Effects of AZD5305 alone, Darolutamide alone, and in Combination Given Prior to Radical Prostatectomy in Men with Newly Diagnosed Prostate Cancer (ASCERTAIN)
IRAS ID
1007784
Contact name
Sadia Akhtar
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
ASCERTAIN is an open-label, randomised, Phase-I, multi-centre study to investigate the mechanism of action of AZD5305 or darolutamide alone, or when given in combination in patients with prostate cancer and are eligible for curative radical prostatectomy.
AZD5305 is a type of drug known as a poly-adenosine di-phosphate ribose polymerase (PARP) inhibitor; it works by inhibiting the enzyme ‘PARP’, a protein found in cells, that plays a role in the repair and growth of cells, including cancer cells.
Darolutamide belongs to a class of drugs called androgen receptor inhibitors. In the body, Darolutamide works by blocking androgen receptors in cancer cells from binding to androgens, preventing actions that can allow cancer cells to survive and proliferate.
This study will help us understand their effects on biomarker levels in tumour and blood. The study will also evaluate how much of these drugs are in blood at various times and provide more safety and tolerability data Additionally, the study will help us to better understand the disease and its associated health problems.
The study will be conducted at approximately 15 centres in 6 countries. Participants will be allocated to either treatment (up to100 biomarker evaluable patients) or to no-treatment (up to 20 biomarker evaluable patients).
Allocation to treatment or no-treatment arms would be decided by the participant and Investigator during screening.
Following the screening visit, eligible participants who consented to treatment will be randomised on a 2:1:2 basis to receive one of the following 3 study treatments:
1. AZD5305 alone(up to 40 evaluable patients),
2. Darolutamide alone (up to 20 evaluable patients) or,
3. AZD5305 + darolutamide (up to 40 evaluable patients).
The study duration will vary, participants will receive 21 days (+up to 7 days) of study treatment. The follow-up is expected to happen 28 (+ up to 28) days after surgery.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0181
Date of REC Opinion
26 Sep 2023
REC opinion
Further Information Favourable Opinion