Blood for Immune Response to Provenge® in HRPC

NCT01274572 | Withdrawn

• 1 other identifier: MC 10-11
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Immune Response

  Standard of Care Drug Immune Response

  Additional Blood Sample

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Mary Crowley Medical Research Center: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• John Nemunaitis, MD

  Mary Crowley Cancer Research Centers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: January 11, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 7, 2015

Record last verified: 2015-04