Study on Abiraterone and Prednisone or Darolutamide for Treating Advanced Prostate Cancer

Sponsor: Mamta Parikh

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06173362

Provider View

This phase II clinical trial is comparing the effects of two treatments, abiraterone with prednisone or darolutamide, in patients with advanced prostate cancer. The study aims to understand how these treatments work and their side effects.

Patient Parameters

Program Overview

This study is exploring two different treatments for advanced prostate cancer, which is cancer that has spread beyond the prostate. The treatments being compared are abiraterone with prednisone and darolutamide. Abiraterone works by reducing male hormones that help prostate cancer grow, while darolutamide blocks these hormones from being used by cancer cells. Prednisone is used to reduce inflammation. The goal is to see how well these treatments are tolerated and to compare their side effects.

Description

The main goal of this study is to see how well patients tolerate the treatments.

Secondary goals include:

  • Understanding how different groups of patients tolerate the treatments.
  • Measuring the response of prostate-specific antigen (PSA) levels after 7 months.

Patients will be divided into two groups based on their doctor's choice:

  • Group 1: Patients will receive abiraterone and prednisone as per standard care. This treatment will continue for up to one year unless the disease worsens or side effects become too severe. Blood samples will be collected during the study.

  • Group 2: Patients will receive darolutamide as per standard care. This treatment will also continue for up to one year unless the disease worsens or side effects become too severe. Blood samples will be collected during the study.

After finishing the treatment, patients will be monitored for a total of three years.

Eligibility Criteria

Inclusion Criteria

  • Must understand and be willing to sign a consent form.
  • Have a confirmed diagnosis of prostate cancer.
  • Have advanced prostate cancer suitable for treatment with abiraterone and prednisone or darolutamide.
  • Should be receiving hormone therapy or have had surgery to remove the testicles.
  • Be in good general health with a performance status score of 0 to 2.
  • Be 18 years or older.
  • Have a life expectancy of at least 6 months.
  • Be willing to follow the study schedule and procedures.

Exclusion Criteria

  • Have been taking abiraterone or darolutamide for more than 28 days before joining the study.
  • Have any condition that would prevent understanding the study or affect safety or compliance during the trial.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.