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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This study has been withdrawn prior to enrollment.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 (Responsible Party):
Mary Crowley Medical Research Center
ClinicalTrials.gov Identifier:
NCT01274572
First received: January 10, 2011
Last updated: April 6, 2015
Last verified: April 2015
  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.

Condition
Prostate Cancer

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:


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

Primary Outcome Measures:
  • Immune Response [ Time Frame: Additional Blood Sample ] [ Designated as safety issue: No ]
    Standard of Care Drug Immune Response


Enrollment: 0
Study Start Date: January 2011
Study Completion Date: June 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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

Inclusion Criteria:

Patients who plan to receive standard of care Provenge® (Sipuleucel-T) at their primary physican's office.

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274572

Sponsors and Collaborators
Mary Crowley Medical Research Center
Investigators
Principal Investigator: John Nemunaitis, MD Mary Crowley Cancer Research Centers
  More Information

Responsible Party: 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: April 6, 2015
Health Authority: United States: Institutional Review Board

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 December 09, 2016