Blood for Immune Response to Provenge® in HRPC
This study has been withdrawn prior to enrollment.
(Drug became available with insurance reimbursement)
Information provided by:
Mary Crowley Medical Research Center
First received: January 10, 2011
Last updated: June 21, 2011
Last verified: June 2011
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.
Immune Response to Provenge
||Observational Model: Case-Only
Time Perspective: Prospective
||Blood Samples to Evaluate Immune Response to Provenge® (Sipuleucel-T) inHormone Refractory Metastatic Prostate Cancer Patients
| Estimated Enrollment:
| Study Start Date:
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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).
No Contacts or Locations Provided
No publications provided
||John Nemunaitis, MD, Executive Medical Director, Mary Crowley Medical Research Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 10, 2011
||June 21, 2011
||United States: Mary Crowley Medical Research Center IRB
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 15, 2014
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male