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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by Dendreon
Information provided by (Responsible Party):
Dendreon Identifier:
First received: November 12, 2012
Last updated: May 10, 2017
Last verified: May 2017
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

Estimated Enrollment: 350
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:
  • 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.

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.

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:


  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 identifier: NCT01727154

Contact: Evett Oh 949-436-9104
Contact: Shabnam Vaziri 206-455-2323

  Hide Study Locations
United States, Arizona
21st Century Oncology Completed
Scottsdale, Arizona, United States, 85251
Arizona Oncology Associates, PC - HOPE Withdrawn
Tucson, Arizona, United States, 85712
Urological Associates of Southern Arizona, P.C. Withdrawn
Tucson, Arizona, United States, 85741, 85715
United States, California
USC/Norris Comprehensive Cancer Center, LAC & USC Medical Center Withdrawn
Los Angeles, California, United States, 90033
Tower Urology / Tower Research Institute Completed
Los Angeles, California, United States, 90048
Prostate Oncology Specialists, Inc. Completed
Marina del Rey, California, United States, 90292
United States, Colorado
The Urology Center of Colorado Recruiting
Denver, Colorado, United States, 80211
Contact: Robin Dorsey, CCRC    303-762-7155   
Principal Investigator: Lawrence I Karsh, MD, FACS         
United States, District of Columbia
Howard University Cancer Center Recruiting
Washington, D.C., District of Columbia, United States, 20060
Contact: Evelyn Smith-Owusu, MD    202-806-9122   
Principal Investigator: Pamela Coleman, MD         
United States, Florida
21st Century Oncology Withdrawn
Fort Myers, Florida, United States, 33908
United States, Georgia
Midtown Urology and Midtown Urology Surgical Center Withdrawn
Atlanta, Georgia, United States, 30324
Georgia Urology, P.A. Withdrawn
Marietta, Georgia, United States, 30060
United States, Indiana
First Urology, PSC Recruiting
Jeffersonville, Indiana, United States, 47130
Contact: Debbie Johnson    812-206-8161   
Principal Investigator: James Bailen, MD         
United States, Kansas
Cancer Center of Kansas Recruiting
Wichita, Kansas, United States, 67214
Contact: Billie Voth-Moore    316-613-4317   
Contact: Pat Stone    316-613-4313   
Principal Investigator: Shaker Dakhil, MD         
United States, Louisiana
Tulane University Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Patrick Cotogno    504-988-6542   
Principal Investigator: Alton Sartor, MD         
Highland Clinic Terminated
Shreveport, Louisiana, United States, 71106
United States, Maryland
Chesapeake Urology Research Associates Terminated
Towson, Maryland, United States, 21204
United States, Massachusetts
Tufts Medical Center Completed
Boston, Massachusetts, United States, 02111
United States, Michigan
Henry Ford Health System Completed
Detroit, Michigan, United States, 48202
Karmanos Cancer Institute at Farmington Hills Withdrawn
Farmington Hills, Michigan, United States, 48334
Michigan Institute of Urology Completed
Troy, Michigan, United States, 48084
United States, Missouri
St. Louis Cancer Care, LLP Completed
Bridgeton, Missouri, United States, 63044
St. Louis Cancer Care, LLP Completed
Saint Louis, Missouri, United States, 63127
United States, Nebraska
Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center Recruiting
Lincoln, Nebraska, United States, 68510
Contact: Sheila LeGrande    402-327-7363   
Principal Investigator: Nathan Green, MD         
Urology Cancer Center & GU Research Network Withdrawn
Omaha, Nebraska, United States, 68130
United States, Nevada
Comprehensive Cancer Centers of Nevada Completed
Henderson, Nevada, United States, 89052, 89014, 89074
Comprehensive Cancer Centers of Nevada Completed
Las Vegas, Nevada, United States, 89169, 89128, 98148
United States, New Jersey
Delaware Valley Urology, LLC Recruiting
Mount Laurel, New Jersey, United States, 08054
Contact: Kristen Schneider    856-252-1000 ext 1031   
Principal Investigator: Adam Perzin, MD         
United States, New York
New York Oncology Hematology, PC Withdrawn
Albany, New York, United States, 12206
National Translational Research Group, Inc. Recruiting
East Setauket, New York, United States, 11733
Contact: Michelle Strano    631-751-3000 ext 170   
Principal Investigator: Jeffrey Vacirca, MD         
Queens Medical Associates Withdrawn
Fresh Meadows, New York, United States, 11366
NYU Clinical Cancer Center, NYU Langone Medical Center Withdrawn
New York, New York, United States, 10016
Premier Medical Group of the Hudson Valley Completed
Poughkeepsie, New York, United States, 12601
Associated Medical Professionals of NY, PLLC Recruiting
Syracuse, New York, United States, 13210
Contact: Charity Cowley    315-478-4185 ext 313   
Contact: Tonya Godfrey, RN    315-478-4185 ext 312   
Principal Investigator: Christopher Pieczonka, MD         
Montefiore Medical Center Completed
The Bronx, New York, United States, 10461
United States, North Carolina
Carolina Urology Partners Recruiting
Gastonia, North Carolina, United States, 28054
Contact: Melissa Cloude    704-869-0075   
Principal Investigator: Robert Waterhouse, MD         
Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina Completed
Raleigh, North Carolina, United States, 27607
United States, Ohio
TriState Urologic Services PSC Inc., dba The Urology Group Completed
Cincinnati, Ohio, United States, 45212
United States, Oklahoma
Urologic Specialists of Oklahoma Completed
Tulsa, Oklahoma, United States, 74146
United States, Oregon
Providence Health & Services Completed
Portland, Oregon, United States, 97213
Oregon Urology Institute Recruiting
Springfield, Oregon, United States, 97477
Contact: Stephanie Kerns    541-284-5508   
Principal Investigator: Bryan Mehlhaff, MD         
Northwest Cancer Specialists, PC Completed
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Urologic Consultants of SE PA Recruiting
Bala-Cynwyd, Pennsylvania, United States, 19004
Contact: Kathy Markopoulos    610-667-0458   
Principal Investigator: Laurence Belkoff, DO         
United States, South Carolina
South Carolina Oncology Associates Completed
Columbia, South Carolina, United States, 29210
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Nicole Brenwald, RN, CCRC    843-449-1010 ext 265   
Principal Investigator: Neal Shore, MD         
United States, Tennessee
Urology Associates, P.C. Recruiting
Nashville, Tennessee, United States, 37209
Contact: Joe Wallace    615-250-9267   
Principal Investigator: David Morris, MD         
United States, Texas
Texas Oncology - Austin Midtown Withdrawn
Austin, Texas, United States, 78705
Texas Oncology - Austin Central Withdrawn
Austin, Texas, United States, 78731
Texas Oncology - Austin North Withdrawn
Austin, Texas, United States, 78758
Texas Oncolocy - South Austin Withdrawn
Austin, Texas, United States, 79745
Texas Oncology - Cedar Park Withdrawn
Cedar Park, Texas, United States, 78613
Texas Oncology - Fort Worth Terminated
Fort Worth, Texas, United States, 76104, 76132
Texas Oncology - Seton-Williamson Withdrawn
Round Rock, Texas, United States, 78665
Texas Oncology - Round Rock Withdrawn
Round Rock, Texas, United States, 78681
Texas Oncology - Waco Withdrawn
Waco, Texas, United States, 76712
United States, Utah
Huntsman Cancer Hospital/University of Utah School of Medicine Withdrawn
Salt Lake City, Utah, United States, 84112
United States, Virginia
Urology of Virginia, PLLC Recruiting
Virginia Beach, Virginia, United States, 23462
Contact: Michele Schindler    757-452-3465   
Principal Investigator: Michael Williams, MD         
United States, Washington
Seattle Cancer Care Alliance Completed
Seattle, Washington, United States, 98109-1023
University of Washington Medical Centerl Completed
Seattle, Washington, United States, 98195
Northwest Cancer Specialists Completed
Vancouver, Washington, United States, 98684, 98683
Sponsors and Collaborators
Study Director: Robert Israel, MD Valeant Pharmaceuticals North America LLC
  More Information

Responsible Party: Dendreon Identifier: NCT01727154     History of Changes
Other Study ID Numbers: P11-4
Study First Received: November 12, 2012
Last Updated: May 10, 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on May 25, 2017