UPCI #17-095 – Prostate Cancer Study

STUDY BASICS

Did you have surgery for high-risk prostate cancer and currently have a rising PSA (prostate-specific antigen) level? If so, you may be eligible to participate in a research study to help compare three different hormonal treatments to find out which one is the most effective for lowering PSA levels and slowing or stopping the return of prostate cancer.

STUDY PURPOSE

Men who have had surgery for high-risk prostate cancer are typically monitored with a PSA (prostate-specific antigen) blood test that measures levels of a protein produced by cells in the prostate gland. In general, the higher the PSA level in the blood, the more likely it is that the cancer is growing. Although treatments exist for men whose PSA levels rise following surgery, researchers are not sure which treatment is best. The purpose of this study is to compare three different hormonal treatments and find out which one is the most effective for lowering PSA levels and slowing or stopping the return of prostate cancer.

COULD THIS STUDY BE RIGHT FOR YOU?

• Men ages 18 and up
• Diagnosed with high-risk prostate cancer
• Have already undergone surgery for the removal of your prostate gland
• May or may not have had radiation therapy
• Currently have rising PSA blood levels

WHAT PARTICIPANTS CAN EXPECT

This study involves an initial screening period of up to 4 weeks to find out if you are eligible to participate in the study. Eligible participants will be randomly assigned (like drawing straws) to one of three study drug dosing arms:

• Group A will receive leuprolide or degarelix, which are both FDA-approved drugs to treat advanced prostate cancer.
• Group B will receive leuprolide or degarelix, plus apalutamide. All three drugs are FDA-approved to treat some types of prostate cancer, but the combination is considered investigational.
• Group C will receive leuprolide or degarelix, plus apalutamide and abiraterone acetate. These drugs are also FDA-approved to treat some types of prostate cancer, but the combination is considered investigational.

Participants will be on the study drugs for 12 months. During the study, participants will have the following tests and assessments: physical exams, blood draws, CT or MRI scan, bone scan, questionnaires, and others as needed. Following treatment, participants will have monthly labs and will be contacted every 6 months for follow up.