Saruparib for High-Risk Prostate Cancer

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 3 Interventional Study
Prostate Cancer
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
700 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for

This trial is looking for men with high-risk prostate cancer who have a specific gene mutation. Participants will receive either the drug Saruparib or a placebo along with standard radiation and hormone therapy to see how well they can avoid cancer spread.

Are You a Good Fit for This Trial?
Must be taking Androgen deprivation therapy
Rules you out Myelodysplastic syndromeAcute myeloid leukemiaActive hepatitis BActive hepatitis CHIV infection

You may be able to join if

  • I have been diagnosed with prostate cancer.
  • I am newly diagnosed with high-risk or very high-risk prostate cancer.
  • I have a confirmed BRCA1 or BRCA2 mutation.
  • I have a life expectancy of at least 12 months.
  • I have adequate organ and bone marrow function.
  • I have not had any treatment within 10 months of my diagnosis.
  • I use a form of birth control during the study.
  • I have had the necessary scans that show no evidence of cancer outside the pelvis.

You may not be able to join if

  • I have a history of myelodysplastic syndrome or acute myeloid leukemia.
  • I have any known predisposition to bleeding.
  • I have severe low blood cell counts for more than 2 weeks.
  • I have a history of significant heart problems.
  • I have active hepatitis B or C.
  • I have active HIV infection.
  • I have had chemotherapy or immunotherapy before.
  • I am allergic to Saruparib or its ingredients.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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 Locations
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Eligibility Criteria
Inclusion 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 radical prostatectomy. * Provision of a fo…
Contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

CONTACT