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 September 2014 by Dendreon
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01727154
First received: November 12, 2012
Last updated: September 19, 2014
Last verified: September 2014

November 12, 2012
September 19, 2014
October 2012
December 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01727154 on ClinicalTrials.gov Archive Site
Not Provided
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Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T
Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T

The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood, serum, manufacturing samples

Non-Probability Sample

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.

Prostate Cancer
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
Sipuleucel-T
Intervention: Biological: Sipuleucel-T
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
Not Provided
December 2014   (final data collection date for primary outcome measure)

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

Male
18 Years and older
No
United States
 
NCT01727154
P11-4
No
Dendreon
Dendreon
Not Provided
Study Director: Candice McCoy, MD Dendreon
Dendreon
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP