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:NCT05938270

EudraCT identifier:N/A

CTIS identifier:2023-503691-25-00

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, Darolutamide

Sex

Male

Estimated Enrollment

120

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 21 Sept 2023
Estimated Primary Completion Date: 25 Feb 2025
Estimated Study Completion Date: 25 Feb 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria