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
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.
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.
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