Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
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.
Age
18–100
Sex
MALE
Healthy volunteers
Not accepted
