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Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T (PRIME)

This study has been terminated.
(Completion of 3yr follow up)
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01727154
First received: November 12, 2012
Last updated: July 6, 2017
Last verified: July 2017
  Purpose
The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).

Condition Intervention
Prostate Cancer Biological: Sipuleucel-T

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T

Resource links provided by NLM:


Further study details as provided by Dendreon:

Primary Outcome Measures:
  • To evaluate the immune response following sipuleucel-T therapy for all subjects [ Time Frame: up to 52 weeks ]
    To evaluate the immune response following sipuleucel-T therapy for all subjects


Biospecimen Retention:   Samples With DNA
Whole blood, serum, manufacturing samples

Enrollment: 52
Study Start Date: October 2012
Estimated Study Completion Date: January 2022
Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Sipuleucel-T Biological: 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 Names:
  • PROVENGE
  • APC8015

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

•None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727154

  Hide Study Locations
Locations
United States, Arizona
21st Century Oncology
Scottsdale, Arizona, United States, 85251
United States, California
Tower Urology / Tower Research Institute
Los Angeles, California, United States, 90048
Prostate Oncology Specialists, Inc.
Marina del Rey, California, United States, 90292
United States, Colorado
The Urology Center of Colorado
Denver, Colorado, United States, 80211
United States, District of Columbia
Howard University Cancer Center
Washington, D.C., District of Columbia, United States, 20060
United States, Indiana
First Urology, PSC
Jeffersonville, Indiana, United States, 47130
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
Highland Clinic
Shreveport, Louisiana, United States, 71106
United States, Maryland
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Michigan Institute of Urology
Troy, Michigan, United States, 48084
United States, Missouri
St. Louis Cancer Care, LLP
Bridgeton, Missouri, United States, 63044
St. Louis Cancer Care, LLP
Saint Louis, Missouri, United States, 63127
United States, Nebraska
Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States, 68510
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052, 89014, 89074
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169, 89128, 98148
United States, New Jersey
Delaware Valley Urology, LLC
Mount Laurel, New Jersey, United States, 08054
United States, New York
National Translational Research Group, Inc.
East Setauket, New York, United States, 11733
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States, 12601
Associated Medical Professionals of NY, PLLC
Syracuse, New York, United States, 13210
Montefiore Medical Center
The Bronx, New York, United States, 10461
United States, North Carolina
Carolina Urology Partners
Gastonia, North Carolina, United States, 28054
Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina
Raleigh, North Carolina, United States, 27607
United States, Ohio
TriState Urologic Services PSC Inc., dba The Urology Group
Cincinnati, Ohio, United States, 45212
United States, Oklahoma
Urologic Specialists of Oklahoma
Tulsa, Oklahoma, United States, 74146
United States, Oregon
Providence Health & Services
Portland, Oregon, United States, 97213
Oregon Urology Institute
Springfield, Oregon, United States, 97477
Northwest Cancer Specialists, PC
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, United States, 19004
United States, South Carolina
South Carolina Oncology Associates
Columbia, South Carolina, United States, 29210
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Urology Associates, P.C.
Nashville, Tennessee, United States, 37209
United States, Texas
Texas Oncology - Fort Worth
Fort Worth, Texas, United States, 76104, 76132
United States, Virginia
Urology of Virginia, PLLC
Virginia Beach, Virginia, United States, 23462
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
University of Washington Medical Centerl
Seattle, Washington, United States, 98195
Northwest Cancer Specialists
Vancouver, Washington, United States, 98684, 98683
Sponsors and Collaborators
Dendreon
Investigators
Study Director: Robert Israel, MD Valeant Pharmaceuticals North America LLC
  More Information

Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01727154     History of Changes
Other Study ID Numbers: P11-4
Study First Received: November 12, 2012
Last Updated: July 6, 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 24, 2017