CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
sipuleucel-T +2 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/NCT01807065
NCT01807065Phase 2Completed

Randomized Phase II Trial of Sipuleucel T Immunotherapy Preceded by Sensitizing Radiation Therapy and Sipuleucel-T Alone in Patients With Castrate Resistant Metastatic Prostate Cancer

City of Hope Medical Center·interventional·Posted Mar 8, 2013·Updated Aug 25, 2020

In Brief

A Phase 2 clinical trial evaluating sipuleucel-T, external beam radiation therapy, and 1 other intervention for Adenocarcinoma of the Prostate and 5 related conditions. Completed, enrolled 51 participants across 3 sites.

Detailed Summary

This randomized phase II trial studies how well giving sipuleucel-T with or without radiation therapy works in treating patients with hormone-resistant metastatic prostate cancer. Vaccines may help the body build an effective immune response to kill tumor cells. Radiation therapy uses high energy x rays to kill tumor cells. It is not yet known whether giving sipuleucel-T vaccine is more effective with or without radiation therapy in treating prostate cancer

Study Details

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 8, 2013
Enrollment StartJun 7, 2013
Primary CompletionDec 31, 2018
Study CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 13.3 years ago

Interventions

sipuleucel-Tbiological

Given IV

external beam radiation therapyradiation

Undergo external beam radiation therapy

laboratory biomarker analysisother

Correlative studies