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Brief Title: 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
Official 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
Study ID: NCT01751451
Brief Summary: 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 castration-resistant prostate cancer who have received prior docetaxel (chemotherapy). In December 2012, the FDA approved Zytiga ® in combination with prednisone to treat patients with metastatic castration-resistant prostate cancer 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. The purpose of this study is to evaluate abiraterone acetate and prednisone in combination with degarelix as a possible treatment for PSA recurrent prostate cancer as compared to abiraterone acetate alone and degarelix alone. This will be the first time these drugs will be used together.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Northwestern University, Feinberg School of Medicine, Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Karmanos Cancer Institute, Wayne State University, Detroit, Michigan, United States
Urology Cancer Center and GU Research Network, Omaha, Nebraska, United States
Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York, United States
Memorial Sloan Kettering West Harrison, Harrison, New York, United States
NorthShore University Health System, Long Island City, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Weill Cornell Medical Center, New York, New York, United States
Memorial Sloan Kettering at Mercy Medical Center, Rockville Centre, New York, United States
Memoral Sloan Kettering Cancer Center at Phelps, Sleepy Hollow, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Oregon Health & Science University Knight Cancer Institute, Portland, Oregon, United States
Name: Howard I Scher, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR