Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T
NCT ID: NCT01727154
Last Updated: 2019-08-19
Study Results
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View full resultsBasic Information
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TERMINATED
139 participants
OBSERVATIONAL
2012-10-31
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Sipuleucel-T
Sipuleucel-T
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Interventions
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Sipuleucel-T
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT)
* Subjects have not yet undergone leukapheresis for their first dose of sipuleucel-T
* Subjects must understand and sign an informed consent form prior to their first leukapheresis
Exclusion Criteria
18 Years
MALE
No
Sponsors
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Dendreon
INDUSTRY
Responsible Party
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Principal Investigators
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Bruce Brown, MD
Role: STUDY_DIRECTOR
Dendreon Pharmaceuticals, LLC
Locations
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21st Century Oncology
Scottsdale, Arizona, United States
Tower Urology / Tower Research Institute
Los Angeles, California, United States
Prostate Oncology Specialists, Inc.
Marina del Rey, California, United States
The Urology Center of Colorado
Denver, Colorado, United States
Howard University Cancer Center
Washington D.C., District of Columbia, United States
First Urology, PSC
Jeffersonville, Indiana, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Tulane University
New Orleans, Louisiana, United States
Highland Clinic
Shreveport, Louisiana, United States
Chesapeake Urology Research Associates
Towson, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Michigan Institute of Urology
Troy, Michigan, United States
St. Louis Cancer Care, LLP
Bridgeton, Missouri, United States
St. Louis Cancer Care, LLP
St Louis, Missouri, United States
Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Delaware Valley Urology, LLC
Mount Laurel, New Jersey, United States
National Translational Research Group, Inc.
East Setauket, New York, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
Associated Medical Professionals of NY, PLLC
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Carolina Urology Partners
Gastonia, North Carolina, United States
Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina
Raleigh, North Carolina, United States
TriState Urologic Services PSC Inc., dba The Urology Group
Cincinnati, Ohio, United States
Urologic Specialists of Oklahoma
Tulsa, Oklahoma, United States
Providence Health & Services
Portland, Oregon, United States
Oregon Urology Institute
Springfield, Oregon, United States
Northwest Cancer Specialists, PC
Tualatin, Oregon, United States
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, United States
South Carolina Oncology Associates
Columbia, South Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology Associates, P.C.
Nashville, Tennessee, United States
Texas Oncology - Fort Worth
Fort Worth, Texas, United States
Urology of Virginia, PLLC
Virginia Beach, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Washington Medical Centerl
Seattle, Washington, United States
Northwest Cancer Specialists
Vancouver, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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P11-4
Identifier Type: -
Identifier Source: org_study_id
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