A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.

Part of paid clinical trials in Detroit, Michigan.

Sponsor
AstraZeneca
Study ID
NCT05938270
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Saruparib (AZD5305) — DRUG
    Saruparib (AZD5305) given orally once daily
  • Darolutamide — DRUG
    Darolutamide tablet is 300mg, given BD orally, twice daily- total dose 1200mg
  • No Treatment — OTHER
    No study treatment is to be taken by the participants in this arm. Radical prostatectomy should be performed as per local practice

Study Details

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).

Key Dates

Start date
Sep 21, 2023
Status verified
Feb 2026
Primary completion
Aug 17, 2026
Completion
Aug 17, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • 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).

Primary Outcome Measure

Fold change in % γH2AX positive cells from baseline value in tumour samples [ Time Frame: Tumour biopsy taken at diagnosis within approx 2 months of Day 1 planned start of study treatment; post treatment tumour biopsy taken following 21 days (+ up to 7 days) of study treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteDetroitMichigan48202-
Research SiteProvidenceRhode Island02903-

Find similar trials in Detroit, MI

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Research Site· Detroit, MIResearch Site· Providence, RI

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