Participant flow

Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy · Source last updated 2010-11-01

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

groups

1. 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 consist of 3 doses administered approximately 2 weeks apart.

   id

   FG000

   title

   Sipuleucel-T

2. description

   All subjects randomized to receive placebo. Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.

   id

   FG001

   title

   Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         54

      2. group Id

         FG001

         num Subjects

         40

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Patient Refused to Continue

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Site Closure

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         82

      2. group Id

         FG001

         num Subjects

         45

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         4

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         57

      2. group Id

         FG001

         num Subjects

         41

      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 January 2000 and September 2004 across 16 clinical trial sites.

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Preserved source evidence · Not medical advice