Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T
- Conditions
- Prostate Cancer
- Interventions
- Biological: Sipuleucel-T
- Registration Number
- NCT01727154
- Lead Sponsor
- Dendreon
- Brief Summary
The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).
- Detailed Description
Subjects will receive sipuleucel-T, and potentially other medications, as part of the clinical trial in which they are concurrently enrolled. For this study, cellular and humoral immune responses will be assessed. No additional study treatments will be conducted beyond what is required for the subject's concurrent clinical trial.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 139
- Subjects must be at least 18 years of age
- 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
•None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Sipuleucel-T Sipuleucel-T -
- Primary Outcome Measures
Name Time Method The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T). Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T. The primary immune response analysis population will include all subjects who receive all 3 infusions of sipuleucel-T. The primary analysis will measure the percentage of subjects who exhibit any immune response at any post-treatment time point (6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Chesapeake Urology Research Associates
🇺🇸Towson, Maryland, United States
Premier Medical Group of the Hudson Valley
🇺🇸Poughkeepsie, New York, United States
Howard University Cancer Center
🇺🇸Washington, District of Columbia, United States
National Translational Research Group, Inc.
🇺🇸East Setauket, New York, United States
Oregon Urology Institute
🇺🇸Springfield, Oregon, United States
Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center
🇺🇸Lincoln, Nebraska, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Associated Medical Professionals of NY, PLLC
🇺🇸Syracuse, New York, United States
21st Century Oncology
🇺🇸Scottsdale, Arizona, United States
Prostate Oncology Specialists, Inc.
🇺🇸Marina Del Rey, California, United States
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
Tower Urology / Tower Research Institute
🇺🇸Los Angeles, California, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
Highland Clinic
🇺🇸Shreveport, Louisiana, United States
First Urology, PSC
🇺🇸Jeffersonville, Indiana, United States
Michigan Institute of Urology
🇺🇸Troy, Michigan, United States
St. Louis Cancer Care, LLP
🇺🇸Saint Louis, Missouri, United States
Carolina Urology Partners
🇺🇸Gastonia, North Carolina, United States
Delaware Valley Urology, LLC
🇺🇸Mount Laurel, New Jersey, United States
Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina
🇺🇸Raleigh, North Carolina, United States
South Carolina Oncology Associates
🇺🇸Columbia, South Carolina, United States
Northwest Cancer Specialists, PC
🇺🇸Tualatin, Oregon, United States
Urology of Virginia, PLLC
🇺🇸Virginia Beach, Virginia, United States
University of Washington Medical Centerl
🇺🇸Seattle, Washington, United States
Urologic Specialists of Oklahoma
🇺🇸Tulsa, Oklahoma, United States
Urologic Consultants of SE PA
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Texas Oncology - Fort Worth
🇺🇸Fort Worth, Texas, United States
Northwest Cancer Specialists
🇺🇸Vancouver, Washington, United States
The Urology Center of Colorado
🇺🇸Denver, Colorado, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Providence Health & Services
🇺🇸Portland, Oregon, United States
TriState Urologic Services PSC Inc., dba The Urology Group
🇺🇸Cincinnati, Ohio, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Urology Associates, P.C.
🇺🇸Nashville, Tennessee, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States