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

July 16, 2019 updated by: Dendreon
The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

139

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
  • PROVENGE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 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).
Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dendreon

Investigators

  • Study Director: Bruce Brown, MD, Dendreon Pharmaceuticals, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

November 12, 2012

First Submitted That Met QC Criteria

November 14, 2012

First Posted (Estimate)

November 15, 2012

Study Record Updates

Last Update Posted (Actual)

August 19, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P11-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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