CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 69 enrolled
Drug / intervention
sipuleucel-T +1 morebiological
Likely dose
abiraterone acetate 1000 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/NCT01487863
NCT01487863Phase 2Completed
CompareCT.gov

A Randomized, Open-label, Phase 2 Trial of Sipuleucel-T With Concurrent Versus Sequential Administration of Abiraterone Acetate Plus Prednisone in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Dendreon·interventional·Posted Dec 8, 2011·Updated Mar 19, 2019

In Brief

A Phase 2 clinical trial evaluating sipuleucel-T and abiraterone acetate for Prostate Cancer Metastatic and 2 related conditions. Completed, enrolled 69 participants across 21 sites.

Detailed Summary

The purpose of this study was to evaluate the impact of concurrent versus sequential administration of abiraterone acetate plus prednisone on the ability to manufacture sipuleucel-T (by assessing sipuleucel-T product parameters), and to assess the safety and efficacy of sipuleucel-T with concurrent or sequential administration of abiraterone acetate plus prednisone in men with metastatic castrate resistant prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer Metastatic, Hormone Refractory Prostate Cancer, Castration-resistant Prostate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 8, 2011
Enrollment StartDec 1, 2011
Primary CompletionMay 1, 2016
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 14.6 years ago

Interventions

sipuleucel-Tbiological

Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).

abiraterone acetatedrug

Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks.