NCT00065442 · FLOW

Participant flow

Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy · Source last updated 2010-09-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

description
All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
id
FG000
title
APC-Placebo
description
All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
id
FG001
title
Sipuleucel-T

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
1
type
Lost to Follow-up
reasons
group Id
FG000
num Subjects
121
group Id
FG001
num Subjects
210
type
Death
reasons
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
9
type
Withdrawal by Subject
milestones
achievements
group Id
FG000
num Subjects
171
group Id
FG001
num Subjects
341
type
STARTED
achievements
group Id
FG000
num Subjects
46
group Id
FG001
num Subjects
121
type
COMPLETED
achievements
group Id
FG000
num Subjects
125
group Id
FG001
num Subjects
220
type
NOT COMPLETED
title
Overall Study

pre Assignment Details

Participants were screened for evaluation of subject eligibility and performance of baseline tests/procedures.

recruitment Details

Participants were randomized between August 2003 and November 2007 across 75 clinical trial sites.

Complete source fields