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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
113
Saruparib (AZD5305) given orally once daily
Darolutamide tablet is 300mg, given BD orally, twice daily- total dose 1200mg
No study treatment is to be taken by the participants in this arm. Radical prostatectomy should be performed as per local practice
Research Site
Detroit, Michigan, United States
Research Site
Providence, Rhode Island, United States
Research Site
Melbourne, Australia
Fold change in % γH2AX positive cells from baseline value in tumour samples
To assess the effects of study treatment on γH2AX change in participants with localised prostate cancer
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
Severity of Treatment-Emergent AEs/SAEs per CTCAE v5.0
To assess the safety and tolerability of study treatment in participants with localised prostate cancer
Time frame: Day 1 to 28 days post-surgery
Incidence of Treatment-Emergent AEs/SAEs per CTCAE v5.0
To assess the safety and tolerability of study treatment in participants with localised prostate cancer
Time frame: Day 1 to 28 days post-surgery
Number of patients with abnormal laboratory values
To assess the safety and tolerability of study treatment in participants with localised prostate cancer
Time frame: Day 1 to 28 days post-surgery
Change from baseline in blood pressure reported as clinically significant
To assess the safety of study treatment in participants with localised prostate cancer
Time frame: Day 1 to 28 days post-surgery
Change from baseline in heart rate reported as clinically significant
To assess the safety of study treatment in participants with localised prostate cancer
Time frame: Day 1 to 28 days post-surgery
Change from baseline in QTc value
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Research Site
South Brisbane, Australia
Research Site
Vancouver, British Columbia, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Québec, Quebec, Canada
Research Site
Amsterdam, Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Barcelona, Spain
...and 6 more locations
To assess the safety of study treatment in participants with localised prostate cancer
Time frame: Day 1 to 28 days post-surgery
Number of participants undergoing planned surgery
To assess the impact of study treatment on surgical feasibility in participants with localised prostate cancer
Time frame: Measured based on Day 1 to Day 21 of treatment
Reasons of participants requiring treatment-related and non-treatment related delays of surgery and delays > 7 days from scheduled day
To assess the impact of study treatment on surgical feasibility in participants with localised prostate cancer
Time frame: Measured based on Day 1 to Day 21 of treatment
Number of participants requiring treatment-related and non-treatment related delays of surgery and delays > 7 days from scheduled day
To assess the impact of study treatment on surgical feasibility in participants with localised prostate cancer
Time frame: Measured based on Day 1 to Day 21 of treatment
Change in Ki-67 % positive cells from baseline in tumour samples
To assess the effects of study treatment on Ki-67 change in participants with localised prostate cancer
Time frame: Measured based on Day 1 to Day 21 of treatment