CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 154 enrolled
Drug / intervention
Rilimogene Galvacirepvec +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/NCT02326805
NCT02326805Phase 2Completed
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Phase II Randomized, Placebo-Controlled Trial of PROSTVAC (PSA-TRICOM) in Patients With Clinically Localized Prostate Cancer Undergoing Active Surveillance

National Cancer Institute (NCI)·interventional·Posted Dec 30, 2014·Updated Jul 19, 2023

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Placebo Administration, and 1 other intervention for Stage I Prostate Adenocarcinoma AJCC v7 and Stage II Prostate Adenocarcinoma AJCC v7. Completed, enrolled 154 participants across 7 sites.

Detailed Summary

This randomized phase II trial studies how well PROSTVAC (prostate-specific antigen \[PSA\]-TRICOM) works in preventing disease progression in patients with prostate cancer undergoing active surveillance. Vaccines made from a person's tumor cells may help the body build an effective immune response to kill tumor cells that express PSA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStage I Prostate Adenocarcinoma AJCC v7, Stage II Prostate Adenocarcinoma AJCC v7
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 30, 2014
Enrollment StartJun 3, 2015
Primary CompletionNov 30, 2018
Study CompletionJul 20, 2022
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 11.5 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Placebo Administrationother

Given SC

Rilimogene Galvacirepvecbiological

Given SC