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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.
Verified April 2013 by Dendreon
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01727154
First received: November 12, 2012
Last updated: April 17, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

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

  Show 30 Study Locations
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: April 17, 2013
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 May 23, 2013