A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Those enrolled in the Booster Study will have had their course of treatment with PROVENGE® immunotherapy and then randomized to the Booster Study to be treated with a single booster dose of sipuleucel-T.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Single Infusion
Assess humoral immune response to PAP and PA2024 after booster infusion
To assess the humoral response ((i.e. antibody titer) to PAP and PA2024 after booster infusion in subjects with metastatic castrate-resistant prostate cancer who have received a single booster dose of sipuleucel-T vs those subjects who have not
Time frame: Once all subjects have completed the study through the 5 year Overall Survival Period
Evaluate the incidence of adverse events including laboratory abnormalities after a single booster does of sipuleucel-T
For all subjects enrolled in the study. Evaluation will include descriptive statistics by treatment arm and in the aggregate of the incidence of adverse events (Number of participants with adverse events (AEs), and the incidence of clinically significant laboratory abnormalities (Number of participants experiencing clinically significant laboratory abnormalities) after initial treatment and booster (Week 28) within and between groups.
Time frame: Once all subjects have completed the study through the 5 year Overall Survival Period
Evaluate Overall Survival
Overall survival after booster infusion of sipuleucel-T defined as the time from randomization to death due to any cause.
Time frame: Once all subjects have completed the study through the 5 year Overall Survival Period. To evaluate safety by determining the incidence of adverse events (AEs), assessing laboratory data for clinically significant laboratory abnormalities, and evaluating
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ACTIVE_NOT_RECRUITING...and 21 more locations