Vaccine Plus Booster Shots in Men With Prostate Cancer Undergoing Treatment With Radical Prostatectomy
Condition: Prostate Cancer; Prostatic Neoplasms; Neoplasms, Prostate
MeSH terms: Prostatic Neoplasms; Neoplasms
Study type: Interventional
Phase: Phase 2

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.
    

Detailed 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.
    

Intervention name(s): PROSTVAC-V/TRICOM; PROSTVAC-F/TRICOM
Intervention type(s): Biological; Biological
Intervention description(s): A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules.; A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Intervention MeSH terms: Metronidazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Surgery; Neoadjuvant; CD8 Cell Infiltrate Response; CD4 Cell Infiltrate Response; Vaccine