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)
AstraZeneca
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).
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).
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * 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 prostatectomy * adequate organ and marrow function as per protocol * capable of giving signed informed consent * For participants participating in the Optional Genetic Research Only: Provision of signed and dated written Optional Genetic Research Information * Available FFPE diagnostic tumour biopsy samples * Participants must use a condom (with spermicide) from screening…
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 SiteDetroit, Michigan
- Research SiteProvidence, Rhode Island
- Research SiteMelbourne
- Research SiteSouth Brisbane
- Research SiteVancouver, British Columbia
- Research SiteToronto, Ontario