CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Sipuleucel-T with Booster +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00715104
NCT00715104Phase 2Completed
CompareCT.gov

An Open Label, Phase 2 Trial of Immunotherapy With Sipuleucel-T (Provenge®) as Neoadjuvant Treatment in Men With Localized Prostate Cancer

Dendreon·interventional·Posted Jul 15, 2008·Updated May 4, 2015

In Brief

A Phase 2 clinical trial evaluating Sipuleucel-T with Booster and Sipuleucel-T without Booster for Prostate Cancer. Completed, enrolled 42 participants across 7 sites.

Detailed Summary

This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant treatment in men with localized prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsUniversity of California, San Francisco

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 15, 2008
Enrollment StartJul 1, 2008
Primary CompletionDec 1, 2012
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 18.0 years ago

Interventions

Sipuleucel-T with Boosterbiological

Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.

Sipuleucel-T without Boosterbiological

Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.