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

Prostate Cancer Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial Description

Background

• Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and follows lung cancer as the leading cause of cancer death.

• Vaccine strategies represent a novel therapeutic approach in the treatment for prostate cancer. One potential target for a prostate cancer vaccine is prostatic specific antigen (PSA), due to its restricted expression on prostate cancer and normal prostatic epithelial cells.

• A neoadjuvant approach may be of potential benefit providing prolonged protection via the patient s immune system against future recurrence.

• PROSTVAC is a vaccine that induces strong immune responses, has shown promising evidence of activity in a randomized phase II study (8.5 month improvement in median overall survival) and is currently in phase III clinical testing.

• This vaccine has been tested in locally recurrent prostate cancer with substantial inflammatory infiltrates within the prostate seen following subcutaneous and intraprostatic injection.

Objectives

-The primary objective is to evaluate the post vaccine immunologic cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) cell infiltrate response of a neoadjuvant vaccine strategy in prostatectomy specimens in patients who plan to undergo radical prostatectomy.

Eligibility

• Patients must have biopsy proven prostate cancer and are surgical candidates for radical prostatectomy

• Must be of sufficient good health to be surgical candidates for radical prostatectomy and have elected radical prostatectomy for management of their prostate cancer

• Granulocyte count is greater than or equal to 1,500/mm(3), Platelet is greater than or equal to 50,000/mm(3), hemoglobin (Hgb) is greater than or equal to 8 g/dL, Bilirubin < 1.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5x upper limit of normal (ULN), Creatinine is less than or equal to 1.5 X ULN

• Pre-intervention biopsy tissue must be available either from outside institution or repeat biopsy

Design

• This study will utilize rV-PSA(L155)-TRICOM (PROSTVAC-V) as a priming vaccination followed by monthly boosting with rF-PSA (L155)-TRICOM (PROSTVAC-F) for 3 months.

• Patients will undergo radical prostatectomy after 4 months of treatment with PROSTVAC-V/F.

• The maximum accrual to the trial will be 27 patients. ;

Related Conditions & MeSH terms

• Neoplasms
• Neoplasms, Prostate
• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT02153918
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Phase: Phase 2
• Start date: May 31, 2014
• Completion date: January 16, 2018