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Vaccine Plus Booster Shots in Men With Prostate Cancer Undergoing Treatment With Radical Prostatectomy

NCT02153918 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-10-12

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

BIOLOGICAL

PROSTVAC-V/TRICOM

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

BIOLOGICAL

PROSTVAC-F/TRICOM

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Peter A Pinto, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-07-28
Completion
2018-01-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02153918 on ClinicalTrials.gov