Study on Saruparib (AZD5305) vs Placebo for Men with Metastatic Castration-Sensitive Prostate Cancer

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06120491

Provider View

This clinical trial is testing whether the drug Saruparib (AZD5305), combined with a doctor's choice of new hormonal agents, is more effective than a placebo in slowing down the progression of metastatic castration-sensitive prostate cancer.

Patient Parameters

Program Overview

The study aims to find out if Saruparib (AZD5305) combined with a new hormonal agent chosen by the doctor can better control prostate cancer that has spread and is sensitive to hormone therapy, compared to a placebo with the same hormonal agent. Researchers will measure how long patients live without the cancer getting worse.

Description

In this study, about 1800 men with metastatic castration-sensitive prostate cancer will be divided into two groups. One group will receive Saruparib (AZD5305) with a new hormonal agent, while the other group will receive a placebo with the same hormonal agent. The treatment will continue until the cancer progresses or for other reasons. Regular scans will be done to monitor the cancer.

All participants will be monitored for survival until the study ends. An independent committee of experts will review the safety and tolerability of Saruparib (AZD5305) with the hormonal agent chosen by the doctor.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older.
  • Diagnosed with prostate cancer that is either new or has returned and is sensitive to hormone therapy. Certain types of prostate cancer are not eligible.
  • Cancer has spread to bones or soft tissues, confirmed by scans.
  • Currently receiving hormone therapy or had surgery to remove testicles within the last 4 months.
  • Good overall health with a performance status of 0 or 1.
  • Provide a tumor tissue sample and blood sample for testing.
  • Confirmed genetic status related to cancer for study group eligibility.
  • Adequate organ and bone marrow function.
  • Must not father children or donate sperm during the study and for 6 months after.
  • Must use a condom during the study and for 6 months after.

Exclusion Criteria

  • History or signs of certain blood disorders (MDS/AML).
  • Known tendency to bleed easily.
  • History of severe low blood cell counts lasting more than 2 weeks.
  • Severe nausea, vomiting, or digestive issues that affect medication absorption.
  • History of another cancer, with some exceptions.
  • Ongoing side effects from previous cancer treatments.
  • Spinal cord compression or brain metastases unless stable and not needing steroids for 4 weeks.
  • Certain heart conditions or history of heart disease.
  • Previous cancer treatments for metastatic prostate cancer, with some exceptions.
  • Recent treatment with blood or growth factor support.
  • Unable to evaluate cancer progression in both bone and soft tissue.

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