Blood for Immune Response to Provenge® in HRPC

NCT ID: NCT01274572

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-06-30

Brief Summary

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.

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mary Crowley Medical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Nemunaitis, MD

Role: PRINCIPAL_INVESTIGATOR

Mary Crowley Cancer Research Centers

Other Identifiers

MC 10-11

Identifier Type: -

Identifier Source: org_study_id