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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dendreon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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