Vaccine Plus Booster Shots in Men With Prostate Cancer Undergoing Treatment With Radical Prostatectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02153918|
Recruitment Status : Completed
First Posted : June 3, 2014
Results First Posted : October 12, 2018
Last Update Posted : October 12, 2018
- 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.
- To see if a vaccine and booster shots given to men with prostate cancer before surgery changes the immune cells in the prostate gland.
- Men age 18 and older who have prostate cancer that has not spread, and who want to have their prostate glands removed as treatment.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Prostatic Neoplasms Neoplasms, Prostate||Biological: PROSTVAC-V/TRICOM Biological: PROSTVAC-F/TRICOM||Phase 2|
- 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.
-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.
- 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
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 31, 2014|
|Actual Primary Completion Date :||July 28, 2017|
|Actual Study Completion Date :||January 16, 2018|
Experimental: Vaccine Plus Booster Shots
PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC
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.
- Changes From Baseline to After Surgery of Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Infiltrates [ Time Frame: Baseline (pre vaccination) and approximately week 10 ]Immunologic CD4 and CD8 cell infiltrate response of a neoadjuvant prime/boost vaccine strategy in prostatectomy specimens. Prostate biopsy specimens are collected and stained for CD4 and CD8 cells. Quantification is reported as the number of stained cells per micron squared of surface area. Change will be noted by utilizing computer automated staining analysis. Density of cell infiltrate will be calculated and the pre and post vaccine values will be compared to determine response to vaccine.
- Count of Participants With Change in Peripheral Prostatic Specific Antigen (PSA)-Specific T Cell Responses [ Time Frame: Baseline (pre vaccination) and week 10 ]Change in peripheral prostatic specific antigen (PSA)-specific T cells will be assessed by the enzyme-linked immunospot (ELISPOT) assay. A change of >250 cluster of differentiation 4 (CD4) or cluster of differentiation 8 (CD8) cells producing cytokine or positive for cluster of differentiation 107a (CD107a) in response to PSA post vaccination relative to baseline will be considered evidence of an immunologic response to the vaccine. The number of subjects developing positive PSA-Specific T cell responses with vaccination will be reported.
- Intraprostatic Treg Cell Infiltration With Cluster of Differentiation 4 (CD4)+Forkhead Box P3 (FOX-P3) Staining [ Time Frame: Baseline (pre vaccination) and post surgery after last dose of vaccine, approximately week 10 ]Prostate biopsy samples collected at baseline and at surgery after last dose of vaccine will be stained for analysis of immune cell infiltrate. Quantification will be reported as number of stained cells per micron squared of surface area.
- Prostatic Specific Antigen (PSA) Changes Secondary to Vaccination [ Time Frame: Baseline (pre vaccination) and approximately week 10 ]A change in PSA secondary to vaccination is defined as an increase or decrease in PSA value beyond the baseline level. PSA levels of 4.0 ng/ml and lower are considered normal.
- Magnetic Resonance Imaging (MRI) Changes Secondary to Vaccination [ Time Frame: Baseline (pre vaccination) and approximately week 10 ]MRI of the prostate was performed for changes in imaging characteristics of prostate cancer pre and post vaccination. MRI changes secondary to vaccination is defined as increase or decrease in the size of lesions from baseline (pre-vaccine) measurements.
- Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) [ Time Frame: Date treatment consent signed to date off study, approximately 33 months and 5 days ]Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153918
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Peter A Pinto, M.D.||National Cancer Institute (NCI)|