Spots Global Cancer Trial Database for A Study of Sipuleucel-T With Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer
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Trial Identification
Brief Title: A Study of Sipuleucel-T With Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer
Official Title: A Randomized, Open-label, Phase 2 Study of Sipuleucel-T With Concurrent Versus Sequential Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer
Study ID: NCT01981122
Conditions
Study Description
Brief Summary: This is a randomized, open-label study designed to assess the effects of sipuleucel-T when administered concurrently or sequentially with enzalutamide.
Detailed Description: This is a randomized, open-label study designed to assess the effects of sipuleucel-T when administered concurrently or sequentially with enzalutamide. This study consists of 3 phases. The screening phase will begin at the completion of the informed consent process and continue through registration. The active phase will begin at registration and continue through the post-treatment visit (30 to 37 days following the last study treatment). The long term follow-up (LTFU) phase will begin after the post-treatment visit and will continue until the subject's death or until Dendreon terminates the study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Urological Associates of Southern Arizona, P.C., Tucson, Arizona, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
The Urology Center of Colorado, Denver, Colorado, United States
Yale University School of Medicine, New Haven, Connecticut, United States
H. Lee Moffitt Cancer and Research Center, Tampa, Florida, United States
Uro Partners/ RMD Clinical Research, Melrose Park, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Lutheran Hospital, Parkview Regional Medical Center, Fort Wayne, Indiana, United States
Johns Hopkins Medicine - Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
GU Research Network, Omaha, Nebraska, United States
North Shore Hematology/Oncology Associates, P.C., East Setauket, New York, United States
Associated Medical Professionals of New York, PLLC, Syracuse, New York, United States
Raleigh Hematology Oncology Associates, D.B.A. Cancer Centers of North Carolina, Raleigh, North Carolina, United States
Cleveland Clinic - Taussig Cancer Institute, Cleveland, Ohio, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Urology Associates, PC, Nashville, Tennessee, United States
Urology of Virginia, Virginia Beach, Virginia, United States
Virginia Mason Medical Center, Virginia Mason Hospital, Seattle, Washington, United States
Northwest Medical Specialties, Rainier Physicians, Tacoma, Washington, United States
Contact Details
Name: Bruce Brown, MD
Affiliation: Dendreon Pharmaceuticals, LLC
Role: STUDY_DIRECTOR
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