Study on Abiraterone, Enzalutamide, or Apalutamide for Prostate Cancer Sensitive to Hormone Therapy

Sponsor: James J. Peters Veterans Affairs Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05422911

Provider View

This clinical trial is exploring the effectiveness of three medications—Abiraterone, Enzalutamide, and Apalutamide—in treating prostate cancer that responds to hormone therapy. The study focuses on Veterans and aims to understand how these treatments work in real-world settings.

Patient Parameters

Program Overview

The study aims to evaluate how well the medications Abiraterone, Enzalutamide, and Apalutamide work in treating prostate cancer that is sensitive to hormone therapy. Researchers are particularly interested in how these treatments perform in Veterans, who often have other health conditions. The study also looks at whether African American Veterans have different outcomes compared to Caucasian Veterans when treated with these medications.

Eligibility Criteria

Inclusion Criteria

  • Must be a Veteran willing to provide written consent.
  • Age 18 or older.
  • Good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Confirmed diagnosis of prostate cancer without certain rare features.
  • Currently receiving or planning to receive hormone therapy or have had surgical removal of the testicles.
  • High risk of cancer progression, shown by specific PSA levels and trends.
  • Have not previously taken Abiraterone, Enzalutamide, or Apalutamide.
  • Expected to live more than 12 months.
  • Stable dose of bone-strengthening medications if applicable.
  • Able to take the study medication and follow study procedures.
  • Meet specific liver, kidney, and blood health criteria.

Exclusion Criteria

  • Previous treatment with certain chemotherapy or hormone therapy drugs for prostate cancer.
  • Participation in a trial for drugs affecting male hormones unless it was a placebo.
  • Recent use of other hormone or biological therapies for prostate cancer.
  • Other cancers unless successfully treated and disease-free for 3 years, or certain skin cancers.
  • History of seizures or conditions that increase seizure risk.
  • Recent serious blood clots that make the patient unstable.
  • Currently taking other experimental drugs.

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