Study on Saruparib vs Placebo with Radiation and Hormone Therapy for High-Risk Prostate Cancer with BRCA Mutation

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT06952803

Provider View

This clinical trial is testing whether adding the drug Saruparib to standard radiation and hormone therapy can improve outcomes for men with high-risk prostate cancer that has a BRCA gene mutation.

Patient Parameters

Program Overview

The study aims to find out if Saruparib, when added to standard treatments like radiation therapy and hormone therapy, can help men with high-risk prostate cancer live longer without the cancer spreading. This is specifically for those with a BRCA gene mutation, which is known to increase cancer risk.

Description

In this study, about 700 men with high-risk prostate cancer will be randomly assigned to receive either Saruparib or a placebo, along with standard hormone therapy and possibly another drug called abiraterone. The participants will be divided into two groups:

  • Cohort A: 400 men with newly diagnosed high-risk prostate cancer or those who have had a recurrence after surgery. They will receive radiation therapy and continuous hormone therapy.
  • Cohort B: 300 men with very high-risk prostate cancer will receive radiation therapy, continuous hormone therapy, and abiraterone.

All participants will be monitored for survival throughout the study. An independent committee of experts will review the safety and effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Men diagnosed with prostate cancer.
  • Newly diagnosed high-risk or very high-risk prostate cancer, or high-risk recurrence after surgery.
  • Must provide a tumor tissue sample.
  • Must have a confirmed BRCA1 or BRCA2 gene mutation.
  • Must have scans showing no cancer spread beyond the pelvis.
  • Must be in good health with a performance status of 0 or 1.
  • Must have a life expectancy of at least 12 months.
  • Must have good organ and bone marrow function.
  • Must have received radiation therapy aimed at curing the cancer.
  • Must be on a hormone therapy regimen.
  • Must agree not to father children or donate sperm during and for 6 months after the study.
  • Must use condoms during and for 6 months after the study.

Exclusion Criteria

  • History of certain blood disorders like myelodysplastic syndrome or leukemia.
  • Conditions that increase bleeding risk, like recent stroke or certain eye diseases.
  • Severe ongoing low blood cell counts.
  • Digestive issues that prevent taking the study drugs.
  • History of another cancer, with some exceptions.
  • Ongoing severe side effects from previous cancer treatments.
  • Heart problems or diseases.
  • Active hepatitis B, C, or HIV infections.
  • Active tuberculosis.
  • Previous chemotherapy or immunotherapy.
  • Recent use of blood or growth factor support.
  • Use of certain medications or supplements that affect the study drugs.
  • Known allergy to Saruparib or its ingredients.

Locations

FACILITYZIPCITYSTATE
Research Site85741TucsonArizona
Research Site92037La JollaCalifornia
Research Site33016HialeahFlorida
Research Site47130JeffersonvilleIndiana
Research Site17033HersheyPennsylvania
Research Site78745AustinTexas
Research Site84112Salt Lake CityUtah
Research Site98109SeattleWashington

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