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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. ;


Study Design


Related Conditions & MeSH terms


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

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