Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT02153918
Brief 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.
Study:
NCT02153918
Study Brief:
Protocol Section:
NCT02153918