A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation

The purpose of the study is to demonstrate superiority of Saruparib (AZD5305) relative to placebo added to a standard radiation therapy (RT) + androgen deprivation therapy (ADT) regimen by assessment of metastases-free survival in participants with high-risk and very high-risk localised/locally advanced prostate cancer with a breast cancer gene mutation (BRCAm).

Trial Details

NCT ID
NCT06952803
Phase
PHASE3
Sponsor
AstraZeneca
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Saruparib
  • Placebo
  • Abiraterone + Prednisolone/Prednisone
  • Androgen Deprivation Therapy (ADT)
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Tucson, Arizona, United States|32.22174,-110.92648
  • La Jolla, California, United States|32.84727,-117.2742
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

  • Male participants with a histologically documented diagnosis of prostate adenocarcinoma.
  • Newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer or a high-risk biochemical recurrence (BCR) following rad…
  • Provision of a formalin fixed and paraffin embedded (FFPE) tumour tissue sample.
  • Confirmed BRCA1 or BRCA2 mutation status by central tumour tissue is required for enrolment.

For full eligibility, visit ClinicalTrials.gov.

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