Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T

Terminated

• Conditions: Prostate Cancer

• Registration Number: NCT01727154
• Lead Sponsor: Dendreon

Brief Summary

The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).

Detailed Description

Subjects will receive sipuleucel-T, and potentially other medications, as part of the clinical trial in which they are concurrently enrolled. For this study, cellular and humoral immune responses will be assessed. No additional study treatments will be conducted beyond what is required for the subject's concurrent clinical trial.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-12
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-15
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Results First Submitted: 2018-08-23
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-16
• Last Update Submitted: 2019-07-16
• Results First Posted: 2019-08-19
• Last Update Posted: 2019-08-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 139

Inclusion Criteria

• Subjects must be at least 18 years of age
• Subjects with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT)
• Subjects have not yet undergone leukapheresis for their first dose of sipuleucel-T
• Subjects must understand and sign an informed consent form prior to their first leukapheresis

Exclusion Criteria

•None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T).	Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T.	The primary immune response analysis population will include all subjects who receive all 3 infusions of sipuleucel-T. The primary analysis will measure the percentage of subjects who exhibit any immune response at any post-treatment time point (6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T).

Trial Locations

Locations (37)

21st Century Oncology; 🇺🇸 Scottsdale, Arizona, United States

Tower Urology / Tower Research Institute; 🇺🇸 Los Angeles, California, United States

Prostate Oncology Specialists, Inc.; 🇺🇸 Marina Del Rey, California, United States

The Urology Center of Colorado; 🇺🇸 Denver, Colorado, United States

Howard University Cancer Center; 🇺🇸 Washington, District of Columbia, United States

First Urology, PSC; 🇺🇸 Jeffersonville, Indiana, United States

Cancer Center of Kansas; 🇺🇸 Wichita, Kansas, United States

Tulane University; 🇺🇸 New Orleans, Louisiana, United States

Highland Clinic; 🇺🇸 Shreveport, Louisiana, United States

Chesapeake Urology Research Associates; 🇺🇸 Towson, Maryland, United States

Scroll for more (27 remaining)