CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
sipuleucel-T +1 morebiological
Likely dose
leuprolide acetate 45.0 mgfrom 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/NCT01431391
NCT01431391Phase 2Completed
CompareCT.gov

A Randomized, Open-Label, Phase 2 Trial Examining the Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men With Non-metastatic Prostate Cancer and a Rising Serum Prostate Specific Antigen After Primary Therapy

Dendreon·interventional·Posted Sep 9, 2011·Updated May 30, 2017

In Brief

A Phase 2 clinical trial evaluating sipuleucel-T and leuprolide acetate for Prostatic Neoplasm and 2 related conditions. Completed, enrolled 68 participants across 14 sites.

Detailed Summary

The main purpose of this study was to determine whether ADT started before or after sipuleucel-T led to a better immune system response. This study also evaluated the safety of sipuleucel-T and ADT treatment, immune system responses over time, the characteristics of sipuleucel-T, and changes in prostate specific antigen (PSA) values over time.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Neoplasm, Prostate Cancer, Prostatic Adenocarcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2011
Enrollment StartSep 1, 2011
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.8 years ago

Interventions

sipuleucel-Tbiological

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).

leuprolide acetatedrug

45.0 mg depot injection, 2 doses 6 months apart