NCT02153918CompletedPhase 2
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
National Cancer Institute (NCI)2 sites in 1 country27 target enrollmentStarted: May 31, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- Changes From Baseline to After Surgery of Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Infiltrates
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Vaccine Plus Booster Shots
Experimental
PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC
Intervention: PROSTVAC-V/TRICOM (Biological)
Vaccine Plus Booster Shots
Experimental
PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC
Intervention: PROSTVAC-F/TRICOM (Biological)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Intraprostatic Treg Cell Infiltration With Cluster of Differentiation 4 (CD4)+Forkhead Box P3 (FOX-P3) Staining(Baseline (pre vaccination) and post surgery after last dose of vaccine, approximately week 10)
- Prostatic Specific Antigen (PSA) Changes Secondary to Vaccination(Baseline (pre vaccination) and approximately week 10)
- Magnetic Resonance Imaging (MRI) Changes Secondary to Vaccination(Baseline (pre vaccination) and approximately week 10)
- Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)(Date treatment consent signed to date off study, approximately 33 months and 5 days)
- Count of Participants With Change in Peripheral Prostatic Specific Antigen (PSA)-Specific T Cell Responses(Baseline (pre vaccination) and week 10)
Investigators
Peter Pinto, M.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)
Study Sites (2)
Loading locations...
Similar Trials
Completed
Phase 2
Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate CancerCastrate Sensitive Prostate CancerNCT03860987National Cancer Institute (NCI)12
Recruiting
Phase 2
Prospects of postoperative prostate cancer adaptive radiation therapyC61Malignant neoplasm of prostateDRKS00033235Klinik und Poliklinik für Strahlentherapie des Universitätsklinikums Essen29
Active, not recruiting
Phase 2
A study to investigate whether a combined Positron emission tomography (PET) and computerised tomography (CT) scan which utilises a tracer called Prostate Specific Membrane Antigen (PSMA) - a substance expressed by prostate cancer cells - can be used to better identify locally recurrent prostate cancer in men with a rising Prostate Specific Antigen (PSA) following radical prostatectomy. The study will then measure the impact of early salvage radiation therapy using advanced localisation techniques on patient survival, clinical toxicity, health related quality of life and prostate cancer-specific quality of life.Recurrent prostate cancerCancer - ProstateACTRN12615001183572Icon Cancer Foundation110
Completed
Phase 2
Normal Prostate: Oxygenation of the Prostate Gland in Men Undergoing Prostate BiopsyProstatic NeoplasmsNCT00152789University Health Network, Toronto40
Terminated
Phase 2
Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate CancerProstate CancerProstatic NeoplasmsNCT02362451National Cancer Institute (NCI)7