A Phase II Study of Abiraterone, Prednisone, and Degarelix in Men with Recurrent Prostate Cancer and a Rising PSA

Protocol
12-187
Full Title
A Phase 2, Randomized, 3-Arm Study of Abiraterone Acetate Alone, Abiraterone Acetate plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients with Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy
Phase
II
Purpose

Abiraterone and degarelix are drugs that are each approved for the treatment of advanced prostate cancer. Degarelix lowers the levels of cancer-fueling testosterone in the body. Abiraterone, which is given with prednisone, works by blocking the production of testosterone by inhibiting an enzyme called CYP17. In this study, researchers want to evaluate the effectiveness of these two drugs used alone and in combination in men with an earlier stage of prostate cancer: disease recurrence which is evident only by a rising PSA level after prostate cancer surgery, before the development of metastatic disease is visible on scans.

In this study, patients will be randomly assigned to receive abiraterone and prednisone; abiraterone, prednisone, and degarelix; or degarelix alone. Abiraterone and prednisone are taken orally (by mouth), while degarelix is given as an injection.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have experienced a 50-percent or more rise in PSA following prostate cancer surgery (radical prostatectomy).
  • Men with prostate cancer that spread to the pelvic lymph nodes may also be eligible to participate.
  • Patients must have a testosterone level of 150 mg/dL or more.
  • At least 4 weeks must have passed since surgery.
  • Patients may not have had prior chemotherapy or hormonal therapy for prostate cancer.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Howard Scher at 646-422-4330.

Disease(s)
Prostate Cancer
Prostate Cancer: Rising PSA After Primary Therapy
Related Diseases

Cancer Clinical Trials: Personalizing for Each Patient

Join our experts for a discussion of clinical trials on November 18. Clinical trials can give patients access to new drugs and other treatments before they are widely available, but how do you know if a trial is right for you?

Learn more »