Study on Radiation and Hormone Therapy with or without Additional Drugs for Rising PSA After Prostate Surgery

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03141671

Provider View

This clinical trial is exploring whether adding two newer drugs, abiraterone and apalutamide, to standard hormone therapy and radiation can improve treatment outcomes for men with rising PSA levels after prostate surgery.

Patient Parameters

Program Overview

This study is testing two different treatment combinations for men whose PSA levels are rising after having surgery for prostate cancer. The standard treatment involves radiation and hormone therapy to block testosterone, which helps prostate cancer grow. Researchers want to see if adding two newer drugs, abiraterone and apalutamide, can improve the effectiveness of this treatment. These drugs work by further reducing testosterone and blocking its effects on cancer cells.

Description

This clinical trial is in Phase II, which means it is testing the safety and effectiveness of a new treatment approach. The study is looking at whether adding two newer drugs, abiraterone acetate and apalutamide, to the standard hormone therapy and radiation can improve outcomes for men with prostate cancer that shows rising PSA levels after surgery.

All participants will receive a standard hormone therapy called LHRHA, which reduces testosterone levels. Some participants will also receive bicalutamide, a drug that helps LHRHA work better. The study is testing if using abiraterone acetate and apalutamide instead of bicalutamide can provide better results by more effectively blocking testosterone and its effects on cancer cells.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer confirmed by lab tests.
  • PSA level of 0.1 or higher after prostate surgery, with at least one additional risk factor such as high Gleason score, PSA over 0.5, or cancer spread to lymph nodes.
  • Eligible for radiation and hormone therapy.
  • Age between 18 and 95 years.
  • Good overall health with a performance status score of 0 to 2.
  • Adequate blood cell counts and organ function based on specific lab tests.
  • Willing to use effective birth control methods during the study and for three months after.
  • Able to understand and agree to the study requirements and procedures.
  • Able to swallow pills.

Exclusion Criteria

  • Use of hormone therapy for more than 30 days before joining the study, unless testosterone levels have recovered.
  • Previous pelvic radiation unless more radiation can be safely given.
  • PSA level over 15 ng/mL at screening.
  • History of seizures or conditions that increase seizure risk.
  • Recent heart problems or blood clots within the last six months.
  • Uncontrolled high blood pressure or active infections.
  • Need for high doses of corticosteroids.
  • Moderate or severe liver problems.
  • Allergic reactions to similar drugs.
  • Other serious health conditions that could interfere with the study.
  • History of another cancer that is currently being treated or has a high risk of returning.
  • Confirmed spread of cancer to the bones.

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