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)
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 1
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).
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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 to 6 months after screening and refrain from fathering a child or donating sperm
Locations
United States
Michigan
Research Site
RECRUITING
Detroit
Rhode Island
Research Site
RECRUITING
Providence
Other Locations
Australia
Research Site
RECRUITING
Melbourne
Research Site
RECRUITING
South Brisbane
Canada
Research Site
RECRUITING
Québec
Research Site
RECRUITING
Toronto
Research Site
RECRUITING
Vancouver
Netherlands
Research Site
RECRUITING
Amsterdam
Research Site
RECRUITING
Nijmegen
Spain
Research Site
RECRUITING
Barcelona
Research Site
RECRUITING
Barcelona
Research Site
RECRUITING
Madrid
Research Site
RECRUITING
Valencia
Turkey
Research Site
WITHDRAWN
Ankara
Research Site
WITHDRAWN
Ankara
Research Site
WITHDRAWN
Istanbul
United Kingdom
Research Site
RECRUITING
Cambridge
Research Site
RECRUITING
Manchester
Research Site
RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date:2023-09-21
Estimated Completion Date:2026-08-17
Participants
Target number of participants:120
Treatments
Other: Saruparib (AZD5305) only
Participant will receive Saruparib (AZD5305) once daily for 21 days (+ up to 7 days) unless unacceptable toxicity or withdrawal of consent. Following the 21 days of study treatment, participants should undergo radical prostatectomy on Day 22 (+ up to 7 days)
Other: Saruparib (AZD5305) + Darolutamide
Participant will receive Saruparib (AZD5305) once daily + darolutamide twice daily for 21 days (+ up to 7 days) unless unacceptable toxicity or withdrawal of consent. Following the 21 days of study treatment, participants should undergo radical prostatectomy on Day 22 (+ up to 7 days).
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
Other: Darolutamide Only
Participant will receive darolutamide twice daily for 21 days (+ up to 7 days) unless unacceptable toxicity or withdrawal of consent. Following the 21 days of study treatment, participants should undergo radical prostatectomy on Day 22 (+ up to 7 days).