Clinical Trial NU MSK13U01
- 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
- Principal Investigator
- Timothy Kuzel
- Status: COMPLETED
- Study Type: Therapeutic, Treatment
- Protocol No:.NU MSK13U01
- The purpose of this study is to evaluate abiraterone acetate and prednisone in combination with degarelix as a possible treatment for Prostate-Specific Antigen (PSA) recurrent prostate cancer as compared to abiraterone acetate alone and degarelix alone.
- In April 2011 the United States Food and Drug Administration (FDA) approved the oral drug abiraterone acetate (Zytiga ®) in combination with prednisone (a steroid) to treat patients with metastatic (spreading) castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone) who have received prior docetaxel (chemotherapy). In December 2012, the FDA approved Zytiga ® in combination with prednisone to treat patients with metastatic (spreading) castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone) who have not received prior chemotherapy.Degarelix (Firmagon ®), a testosterone lowering agent given as a monthly injection is FDA approved for the treatment of patients with advanced prostate cancer. This will be the first time these drugs will be used together.
Some of the eligibility criteria include:
- Participants must be males 18 years old or older.
- Participants must have advanced prostate cancer.
- Participants must have undergone a radical prostatectomy (surgical removal of the prostate gland) and had a normal PSA after surgery that is now rising. Please contact the study doctor for more specifics.
- Description of Treatment
- Participants will be randomized (like the flip of a coin) into one of three groups known as Arms. Arm 1 will take the study drug (abiraterone acetate) plus prednisone. Arm 2 will take the same as Arm 1 and in addition take degarelix. Arm 3 will take degarelix alone. The study drug and prednisone are taken in tablet form (by mouth). Degarelix is given by injection under the skin monthly. Participants will continue on the study for 8 months or until the study doctor feels it is in their best interest to stop.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 01-May-16 01:07 AM
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