A Study to Investigate the Biological Effects of AZD5305, Darolutamide, and in Combination in Men with Newly Diagnosed Prostate Cancer. - ASCERTAIN
Study identifier:D9721C00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:2023-503691-25-00
Will Be Recruiting
Official 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)
Medical condition
prostate cancer
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD5305, AZD5305, Darolutamide, Darolutamide
Sex
Male
Enrollment
120
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 07 Jun 2023
Estimated Primary Completion Date: 09 Oct 2024
Estimated Study Completion Date: 09 Oct 2024
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Basic Science
Verification:
Verified 01 May 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Other: AZD5305 only Participant will receive 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) | Drug: AZD5305 AZD5305 given orally once daily Other Name: Darolutamide is also known as Nubeqa |
| Other: AZD5305 + Darolutamide Participant will receive 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). | Drug: AZD5305 AZD5305 given orally once daily Other Name: Darolutamide is also known as Nubeqa Drug: Darolutamide Darolutamide tablet is 300mg, given BD orally, twice daily- total dose 1200mg Other Name: Darolutamide is also known as Nubeqa |
| 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: 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). | Drug: Darolutamide Darolutamide tablet is 300mg, given BD orally, twice daily- total dose 1200mg Other Name: Darolutamide is also known as Nubeqa |
