Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT02153918
Status:
COMPLETED
Last Update Posted:
2018-10-12
First Post:
2014-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Vaccine Plus Booster Shots in Men With Prostate Cancer Undergoing Treatment With Radical Prostatectomy
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
\- 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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 14-C-0112 | None | None | View |