CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Radium-223 +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/NCT02463799
NCT02463799Phase 2Completed
CompareCT.gov

A Phase 2 Study of Sipuleucel-T With or Without Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-Metastatic Castrate-Resistant Prostate Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Jun 4, 2015·Updated Jul 8, 2021

In Brief

A Phase 2 clinical trial evaluating Radium-223 and Sipuleucel-T for Prostate Cancer. Completed, enrolled 36 participants across 5 sites.

Detailed Summary

This clinical trial studies the effect of radium-223 when added to sipuleucel-T for treating castrate-resistant prostate cancer that has spread to the bone. Sipuleucel-T is an autologous cellular immunotherapy designed to stimulate an immune response against prostate cancer. It has been suggested that the immune response may be strengthened by radiation therapy. Therefore this study is testing whether radium-223 added to sipuleucel-T increases the immune response and anti-tumor effect against prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsDendreon, Bayer

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 4, 2015
Enrollment StartFeb 22, 2016
Primary CompletionDec 12, 2019
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.1 years ago

Interventions

Radium-223drug

6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223

Sipuleucel-Tbiological

3 infusions of sipuleucel-T alone