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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Conditions

Prostate Cancer

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Howard I Scher, MD

Affiliation: Memorial Sloan Kettering Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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