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Blood for Immune Response to Provenge® in HRPC

This study has been withdrawn prior to enrollment.
(Drug became available with insurance reimbursement)
Sponsor:
Information provided by:
Mary Crowley Medical Research Center
ClinicalTrials.gov Identifier:
NCT01274572
First received: January 10, 2011
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
  Purpose

This study is being conducted to assess and monitor immune response in patients with minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be receiving Provenge® (Sipuleucel-T) therapy as part of their standard of care treatment regimen. The trial only involves the collection of additional blood samples for the purposes of monitoring immune response. These samples will be taken at 7 time points before, during and after patients receive Provenge® (Sipuleucel-T). There will be no other study-specific procedures performed (other than the blood draws) nor any use of investigational agents in this study.


Condition
Prostate Cancer
Immune Response to Provenge

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Blood Samples to Evaluate Immune Response to Provenge® (Sipuleucel-T) inHormone Refractory Metastatic Prostate Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mary Crowley Medical Research Center:

Estimated Enrollment: 50
Study Start Date: January 2011
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects that will be included in this study will be receiving Provenge as standard of care treatment for their prostate cancer and will be willing to consent to the additional blood draws.

Criteria

In order for patients to receive treatment with Provenge® (Sipuleucel-T) at the Mary Crowley clinic, patients must consent to the additional blood draws and be willing to come into the clinic in adherence to the schedule of blood sample collections. Patients who do not consent to these immune response blood samples will be unable to receive Provenge® (Sipuleucel-T) at Mary Crowley but will be referred to a another physician and/or clinic able to provide Provenge® (Sipuleucel-T).

  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: John Nemunaitis, MD, Executive Medical Director, Mary Crowley Medical Research Center
ClinicalTrials.gov Identifier: NCT01274572     History of Changes
Other Study ID Numbers: MC 10-11
Study First Received: January 10, 2011
Last Updated: June 21, 2011
Health Authority: United States: Mary Crowley Medical Research Center IRB

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 October 18, 2012