Study Stopped
Administrative reasons
Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T
PRIME
1 other identifier
observational
139
1 country
39
Brief Summary
The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2012
Longer than P75 for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 12, 2012
CompletedFirst Posted
Study publicly available on registry
November 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedResults Posted
Study results publicly available
August 19, 2019
CompletedAugust 19, 2019
July 1, 2019
4.8 years
November 12, 2012
August 23, 2018
July 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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).
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).
Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T.
Study Arms (1)
Sipuleucel-T
Interventions
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.
Eligibility Criteria
Men at least 18 years of age with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT), and have not yet undergone leukapheresis for their first dose of sipuleucel-T.
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dendreonlead
Study Sites (39)
21st Century Oncology
Scottsdale, Arizona, 85251, United States
Tower Urology / Tower Research Institute
Los Angeles, California, 90048, United States
Prostate Oncology Specialists, Inc.
Marina del Rey, California, 90292, United States
The Urology Center of Colorado
Denver, Colorado, 80211, United States
Howard University Cancer Center
Washington D.C., District of Columbia, 20060, United States
First Urology, PSC
Jeffersonville, Indiana, 47130, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Tulane University
New Orleans, Louisiana, 70112, United States
Highland Clinic
Shreveport, Louisiana, 71106, United States
Chesapeake Urology Research Associates
Towson, Maryland, 21204, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Michigan Institute of Urology
Troy, Michigan, 48084, United States
St. Louis Cancer Care, LLP
Bridgeton, Missouri, 63044, United States
St. Louis Cancer Care, LLP
St Louis, Missouri, 63127, United States
Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center
Lincoln, Nebraska, 68510, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052, 89014, 89074, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, 89128, 98148, United States
Delaware Valley Urology, LLC
Mount Laurel, New Jersey, 08054, United States
National Translational Research Group, Inc.
East Setauket, New York, 11733, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601, United States
Associated Medical Professionals of NY, PLLC
Syracuse, New York, 13210, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Carolina Urology Partners
Gastonia, North Carolina, 28054, United States
Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina
Raleigh, North Carolina, 27607, United States
TriState Urologic Services PSC Inc., dba The Urology Group
Cincinnati, Ohio, 45212, United States
Urologic Specialists of Oklahoma
Tulsa, Oklahoma, 74146, United States
Providence Health & Services
Portland, Oregon, 97213, United States
Oregon Urology Institute
Springfield, Oregon, 97477, United States
Northwest Cancer Specialists, PC
Tualatin, Oregon, 97062, United States
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, 19004, United States
South Carolina Oncology Associates
Columbia, South Carolina, 29210, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Urology Associates, P.C.
Nashville, Tennessee, 37209, United States
Texas Oncology - Fort Worth
Fort Worth, Texas, 76104, 76132, United States
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023, United States
University of Washington Medical Centerl
Seattle, Washington, 98195, United States
Northwest Cancer Specialists
Vancouver, Washington, 98684, 98683, United States
Biospecimen
Whole blood, serum, manufacturing samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early termination leading to small numbers of subjects analyzed as a minimum of 200 patients were needed to obtain reliable data; however only 123 were treated. Given the small number of patients enrolled, analyses do not provide reliable results.
Results Point of Contact
- Title
- Shabnam Vaziri
- Organization
- Dendreon
Study Officials
- STUDY DIRECTOR
Bruce Brown, MD
Dendreon Pharmaceuticals, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2012
First Posted
November 15, 2012
Study Start
October 1, 2012
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
August 19, 2019
Results First Posted
August 19, 2019
Record last verified: 2019-07