A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · None · Basic science
Enrollment
113actual
Sites
16
Countries
Australia, Canada, Netherlands +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-09-21 | actual | When the study began enrolling |
| Primary completion | 2026-06-15 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-15 | actual | The whole study's end, after follow-up |
| First posted | 2023-07-10 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Prostate Cancer
Interventions
- Drug: Saruparib (AZD5305) — also filed as Darolutamide is also known as Nubeqa
- Drug: Darolutamide — also filed as Darolutamide is also known as Nubeqa
- Other: No Treatment
Primary outcome
what the primary-completion date above is the date OFFold change in % γH2AX positive cells from baseline value in tumour samples
measured 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
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