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An Open Label, Phase 2 Trial of Immunotherapy With Sipuleucel-T (Provenge®) as Neoadjuvant Treatment in Men With Localized Prostate Cancer
This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant treatment in men with localized prostate cancer.
This is a single center, open label, Phase 2 study. Subjects will be treated with 3 infusions of sipuleucel-T prior to a scheduled radical prostatectomy (RP) surgery. To assess the immune response following treatment with sipuleucel-T, tissue from the prostatectomy specimen will be compared with tissue from the core biopsy specimen obtained prior to treatment with sipuleucel T. Following RP, subjects will be randomized to receive either a booster infusion of sipuleucel T or no further treatment with sipuleucel-T (i.e., booster: no booster).
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Kaiser Permanente Portland
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Start Date
July 1, 2008
Primary Completion Date
December 1, 2012
Completion Date
December 1, 2013
Last Updated
May 4, 2015
42
ACTUAL participants
Sipuleucel-T with Booster
BIOLOGICAL
Sipuleucel-T without Booster
BIOLOGICAL
Lead Sponsor
Dendreon
Collaborators
NCT04550494
NCT05691465
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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