Blood for Immune Response to Provenge® in HRPC

Prostate Cancer Clinical Trial

Official title:

Blood Samples to Evaluate Immune Response to Provenge® (Sipuleucel-T) inHormone Refractory Metastatic Prostate Cancer Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01274572
• Other study ID #: MC 10-11
• Status: Withdrawn
• Phase: N/A
• First received: January 10, 2011
• Last updated: April 6, 2015
• Start date: January 2011
• Est. completion date: June 2011

Study information

• Verified date: April 2015
• Source: Mary Crowley Medical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mary Crowley Medical Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune Response	Standard of Care Drug Immune Response	Additional Blood Sample	No