ClinicaliQ Trial Snapshot
- 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 — Recruiting • Phase III • Oncology • NCT06952803.
- Treatment being tested: Saruparib (AZD5305), a PARP inhibitor, combined with standard radiotherapy and androgen deprivation therapy versus placebo in men with high-risk and very high-risk prostate cancer harbouring BRCA mutations.
- Patient eligibility overview: Men with BRCA-mutated, high-risk or very high-risk localised prostate cancer who are candidates for curative-intent radiotherapy and androgen deprivation therapy.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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).
Eligibility Snapshot
- : * 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 radical prostatectomy. * 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. * Participants required to have a computed tomography (CT) or magnetic resonance imaging (MRI) and a bone scan following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0). * Participants required to have a prostate-specific membrane antigen-positron emission tomography (PSMA-PET) following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomization. * Minimum life expectancy of 12 months. * Adequate organ and bone marrow function as described in study protocol. * All participants will have received either primary or salvage RT. Participants must be eligible for randomisation within…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.