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

Detailed criteria

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

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

Locations (19)

Research Site
Detroit, Michigan
Research Site
Providence, Rhode Island
Research Site
Melbourne
Research Site
South Brisbane
Research Site
Vancouver, British Columbia
Research Site
Toronto, Ontario