A Randomized, Multicenter, Single Blind Study in Men With Metastatic Androgen Independent Prostate Cancer to Evaluate Sipuleucel-T Manufactured With Different Concentrations of PA2024 Antigen
This is a multicenter, single blind, Phase 2 study. Subjects will receive the
investigational product, sipuleucel-T, manufactured with 1 of 3 different concentrations of
PA2024 antigen. The purpose of this study is to compare the changes in CD54 upregulation
between each of these 3 groups of subjects. The study will also evaluate the levels of
immune response, the length of survival, the role of circulating tumor cell levels in the
blood, and changes in quality of life in each of the 3 groups of subjects. All subjects
will be blinded to their cohort assignment to ensure unbiased completion of the quality of
life (QOL) questionnaires. All subjects will be followed for this study for the remainder
of their lives.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Compare the cumulative CD54 upregulation ratio between each of the cohorts.
2010
No
United States: Food and Drug Administration
P07-2
NCT00715078
August 2008
Name | Location |
---|---|
Mount Sinai School of Medicine | New York, New York 10029 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Georgetown University Medical Center | Washington, District of Columbia 20007 |
UCSD Moores Cancer Center | La Jolla, California 93093 |
Kaiser Permanente | Portland, Oregon 97227 |
Sharp Clinical Oncology Research | San Diego, California 92123 |
Indiana University | Indianapolis, Indiana 46202 |
Columbia University Medical Center | New York, New York 10032 |
Northwest Cancer Specialists | Portland, Oregon 97225 |
Providence Medical Center | Portland, Oregon 97213 |
Urology of Virginia, Sentara Medical Group | Norfolk, Virginia 23503 |
Virginia Mason Medical Center Urology and Renal Transplantation | Seattle, Washington 98101 |