CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
PROSTVAC-V/TRICOM +1 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/NCT02153918
NCT02153918Phase 2Completed

A Phase II Study of Neoadjuvant rFowlpox-PSA (L155)-TRICOM (Prostvac-F/TRICOM) in Combination With rVaccinia-PSA (L155)-TRICOM (Prostvac-V/TRICOM) in Men With Prostate Cancer Undergoing Treatment With Radical Prostatectomy

National Cancer Institute (NCI)·interventional·Posted Jun 3, 2014·Updated Oct 12, 2018

In Brief

A Phase 2 clinical trial evaluating PROSTVAC-V/TRICOM and PROSTVAC-F/TRICOM for Prostate Cancer and 2 related conditions. Completed, enrolled 27 participants across 1 site.

Detailed Summary

Background: \- Some men with prostate cancer have their prostate glands removed. The cancer can still come back. Researchers want to know if receiving a vaccine before prostate removal surgery can lead to less recurrence. Objective: \- To see if a vaccine and booster shots given to men with prostate cancer before surgery changes the immune cells in the prostate gland. Eligibility: \- Men age 18 and older who have prostate cancer that has not spread, and who want to have their prostate glands removed as treatment. Design: * Participants will be screened by their regular cancer care. They may have a small piece of prostate removed. * Participants must practice effective birth control before and during the study treatment and for 1 month after the last vaccine booster. * Participants will have a medical history, physical exam, and blood and liver tests. They will be asked about how they perform daily activities. * Participants will have a magnetic resonance imaging (MRI) scan of the prostate. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the scanner. * Participants will be injected with the vaccine, most likely in the leg. They will be injected with the vaccine booster 3 times over several weeks. * At each booster visit, participants will have a medical history, physical exam, and blood and liver tests. * Participants will have another MRI. Then they will have surgery to remove their prostate. * Participants will have 2 follow-up visits during the year after surgery. They will have a medical history, physical exam, and blood test.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 3, 2014
Enrollment StartMay 31, 2014
Primary CompletionJul 28, 2017
Study CompletionJan 16, 2018
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 12.1 years ago

Interventions

PROSTVAC-V/TRICOMbiological

A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules.

PROSTVAC-F/TRICOMbiological

A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.