CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Sipuleucel-T +1 moredrug
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/NCT01818986
NCT01818986Phase 2Completed
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Phase II Trial of Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)

University of Texas Southwestern Medical Center·interventional·Posted Mar 27, 2013·Updated May 6, 2022

In Brief

A Phase 2 clinical trial evaluating Sipuleucel-T and Stereotactic Ablative Body Radiation for Metastatic Castrate-resistant Prostate Cancer and mCRPC. Completed, enrolled 20 participants across 1 site.

Detailed Summary

In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky progressive disease, but also to provide antigen presentation and immune stimulation which is expected to act synergistically to the concurrently administered immunotherapy Sipuleucel-T and thereby significantly improve the treatment outcome for metastatic castrate resistant prostate cancer patients (mCRPC). Both Sipuleucel-T and SABR are FDA approved therapeutic cancer treatment

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Castrate-resistant Prostate Cancer, mCRPC
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 27, 2013
Enrollment StartJul 10, 2013
Primary CompletionDec 20, 2019
Study CompletionMay 25, 2021
TodayJul 3, 2026
Enrollment to primary: 6.4 yearsPosted 13.3 years ago

Interventions

Sipuleucel-Tdrug

Stereotactic Ablative Body Radiationradiation