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 March 2014 by Dendreon
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01727154
First received: November 12, 2012
Last updated: May 14, 2014
Last verified: March 2014
  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 ] [ Designated as safety issue: No ]
    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 Primary Completion Date: December 2014 (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
Genders 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 Recruiting
Scottsdale, Arizona, United States, 85251
Contact: Mary High    480-945-6896    mhigh@rtsx.com   
Principal Investigator: Steven Finkelstein, MD         
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
Tower Urology / Tower Research Institute Recruiting
Los Angeles, California, United States, 90048
Contact: Terry Williams    310-854-9898 ext 178    williamst@towerurology.com   
Principal Investigator: Norman Nemoy, MD         
USC/Norris Comprehensive Cancer Center, LAC & USC Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: Kristina Massopust    323-865-0843    massopust_k@med.usc.edu   
Principal Investigator: David Quinn, MD         
Prostate Oncology Specialists, Inc. Recruiting
Marina del Rey, California, United States, 90292
Contact: Ken Chau    310-827-7707 ext 32    ken@prostateoncology.com   
Principal Investigator: Mark Scholz, MD         
United States, Colorado
The Urology Center of Colorado Recruiting
Denver, Colorado, United States, 80211
Contact: Robin Dorsey, CCRC    303-762-7155    rdorsey@tucc.com   
Principal Investigator: Lawrence I Karsh, MD, FACS         
United States, District of Columbia
Howard University Cancer Center Recruiting
Washington, District of Columbia, United States, 20060
Contact: Sara Horton, MD    202-806-7943    S_Horton@howard.edu   
Principal Investigator: Chiledum Ahaghotu, 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. Recruiting
Marietta, Georgia, United States, 30060
Contact: Yvonne Petit    770-429-9100 ext 2722    ypetit@gaurology.com   
Principal Investigator: Vahan Kassabian, MD         
United States, Indiana
First Urology, PSC Recruiting
Jeffersonville, Indiana, United States, 47130
Contact: Debbie Johnson    812-206-8161    djohnson@1sturology.com   
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    billie.voth@cancercenterofkansas.com   
Contact: Pat Stone    316-613-4313    Pat.stone@cancercenterofkansas.com   
Principal Investigator: Shaker Dakhil, MD         
United States, Louisiana
Tulane University Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Patrick Cotogno    504-988-6542    pcotogno@tulane.edu   
Principal Investigator: Alton Sartor, MD         
Highland Clinic Recruiting
Shreveport, Louisiana, United States, 71106
Contact: Lauren Scheffy    318-213-0383    lscheffy@highlandclinic.com   
Principal Investigator: Manish Dhawan, MD         
United States, Maryland
Chesapeake Urology Research Associates Recruiting
Towson, Maryland, United States, 21204
Contact: Maria Singleton    443-471-5748    msingleton@cua.md   
Principal Investigator: Ronald Tutrone, MD         
United States, Massachusetts
Tufts Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02111
United States, Michigan
Henry Ford Health System Active, not recruiting
Detroit, Michigan, United States, 48202
Karmanos Cancer Institute at Farmington Hills Withdrawn
Farmington Hills, Michigan, United States, 48334
Michigan Institute of Urology Recruiting
Troy, Michigan, United States, 48084
Contact: Jackie Day    248-786-0467    dayj@michiganurology.com   
Principal Investigator: Jason Hafron, MD         
United States, Missouri
St. Louis Cancer Care, LLP Active, not recruiting
Bridgeton, Missouri, United States, 63044
St. Louis Cancer Care, LLP Active, not recruiting
St. 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    sheilal@leadingcancercare.com   
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 Active, not recruiting
Henderson, Nevada, United States, 89052, 89014, 89074
Comprehensive Cancer Centers of Nevada Active, not recruiting
Las Vegas, Nevada, United States, 89169, 89128, 98148
United States, New Jersey
Delaware Valley Urology, LLC Recruiting
Mt. Laurel, New Jersey, United States, 08054
Contact: Brianna Florentine    856-252-1000 ext 1031    bbarile@dvullc.com   
Principal Investigator: Adam Perzin, MD         
United States, New York
New York Oncology Hematology, PC Withdrawn
Albany, New York, United States, 12206
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Srikanth Gajavelli    718-920-6193    SGAJAVEL@montefiore.org   
Principal Investigator: Sanjay Goel, MD         
National Translational Research Group, Inc. Recruiting
East Setauket, New York, United States, 11733
Contact: Loretta Pierzchanowski    631-751-3000 ext 170    lpierzch@NSHOA.com   
Principal Investigator: Jeffrey Vacirca, MD         
Queens Medical Associates Withdrawn
Fresh Meadows, New York, United States, 11366
NYU Clinical Cancer Center, NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Sean Sobin    212-263-4424    sean.sobin@nyumc.org   
Principal Investigator: Anna Ferrari, MD         
Premier Medical Group of the Hudson Valley Recruiting
Poughkeepsie, New York, United States, 12601
Contact: Kimberly Secord    845-437-5002    ksecord@premiermedicalhv.com   
Principal Investigator: Evan Goldfischer, MD         
Associated Medical Professionals of NY, PLLC Recruiting
Syracuse, New York, United States, 13210
Contact: Mark Chilton    315-478-4185 ext 313    mchilton@ampofny.com   
Contact: Tonya Godfrey, RN    315-478-4185 ext 312    tgodfrey@ampofny.com   
Principal Investigator: Christopher Pieczonka, MD         
United States, North Carolina
Carolina Urology Partners Recruiting
Gastonia, North Carolina, United States, 28054
Contact: Melissa Cloude    704-869-0075    melissa.cloude@carolinaurology.com   
Principal Investigator: Robert Waterhouse, MD         
Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina Active, not recruiting
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 Active, not recruiting
Tulsa, Oklahoma, United States, 74146
United States, Oregon
Providence Health & Services Active, not recruiting
Portland, Oregon, United States, 97213
Oregon Urology Institute Recruiting
Springfield, Oregon, United States, 97477
Contact: Stephanie Kerns    541-284-5508    info@oregonurology.com   
Principal Investigator: Bryan Mehlhaff, MD         
Northwest Cancer Specialists, PC Active, not recruiting
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Urologic Consultants of SE PA Recruiting
Bala Cynwyd, Pennsylvania, United States, 19004
Contact: Cheryl Zinar    610-667-0458    Cheryl.ucsepa@covad.net   
Principal Investigator: Laurence Belkoff, DO         
United States, South Carolina
South Carolina Oncology Associates Active, not recruiting
Columbia, South Carolina, United States, 29210
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Stacey Harrelson, RN, CCRC    843-839-1679 ext 268    sharrelson@atlanticurologyclinics.com   
Principal Investigator: Neal Shore, MD         
United States, Tennessee
Urology Associates, P.C. Recruiting
Nashville, Tennessee, United States, 37209
Contact: Joe Wallace    615-250-9267    jawallace@ua-pc.com   
Principal Investigator: Raoul Concepcion, MD         
United States, Texas
Texas Oncolocy - South Austin Withdrawn
Austin, Texas, United States, 79745
Texas Oncology - Austin Midtown Withdrawn
Austin, Texas, United States, 78705
Texas Oncology - Austin North Withdrawn
Austin, Texas, United States, 78758
Texas Oncology - Austin Central Withdrawn
Austin, Texas, United States, 78731
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 - Round Rock Withdrawn
Round Rock, Texas, United States, 78681
Texas Oncology - Seton-Williamson Withdrawn
Round Rock, Texas, United States, 78665
Texas Oncology - Waco Withdrawn
Waco, Texas, United States, 76712
United States, Utah
Huntsman Cancer Hospital/University of Utah School of Medicine Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Elizabeth Lignell    801-213-2780    Elizabeth.Lignell@hsc.utah.edu   
Principal Investigator: Neeraj Agarwal, MD         
United States, Virginia
Urology of Virginia, PLLC Recruiting
Virginia Beach, Virginia, United States, 23462
Contact: Michele Schindler    757-452-3465    mschindler@urologyofva.net   
Principal Investigator: Raymond Lance, MD         
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109-1023
Contact: Viorica Popov    206-288-1136    popovv@uw.edu   
Principal Investigator: Celestia Higano, MD         
University of Washington Medical Centerl Recruiting
Seattle, Washington, United States, 98195
Contact: Viorica Popov    206-288-1136    popovv@uw.edu   
Principal Investigator: Celestia Higano, MD         
Northwest Cancer Specialists Active, not recruiting
Vancouver, Washington, United States, 98684, 98683
Sponsors and Collaborators
Dendreon
Investigators
Study Director: Candice McCoy, MD Dendreon
  More Information

No publications provided

Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01727154     History of Changes
Other Study ID Numbers: P11-4
Study First Received: November 12, 2012
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration

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 29, 2014