Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases.
Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases. During the Active Phase eligible subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. Subjects returned to the clinic for Week 6, Week 10, Month 6, and Month 12 visits. After the Month 12 visit, subjects were to enter the Long Term Follow-up Phase, in which they were contacted every 6 months via telephone. Study Objectives: Primary: Evaluate the immune response generated by sipuleucel-T. Secondary: Evaluate the safety of sipuleucel-T and explore the correlation between sipuleucel-T immune response and overall survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
Orange County Urology Associates
Laguna Hills, California, United States
Oregon Health & Science University
Portland, Oregon, United States
Virginia Mason Hospital
Seattle, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Number of Study Participants Enrolled and Treated Prior to Study Termination
Number of study participants that were enrolled and treated in this trial following completion of study P-11 and prior to study termination.
Time frame: Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015
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