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NCT02153918 · ClinicalTrials.gov registry record · Phase 2
Vaccine Plus Booster Shots in Men With Prostate Cancer Undergoing Treatment With Radical Prostatectomy
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT02153918: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT02153918 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02153918, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- BIOLOGICAL PROSTVAC-V/TRICOM
- BIOLOGICAL PROSTVAC-F/TRICOM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2014-05-31 |
| Est. Completion | 2018-01-16 |
| Phase | Phase 2 |
What the finished NCT02153918 record still lists
NCT02153918 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which PROSTVAC-V/TRICOM is the first listed.
NCT02153918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02153918 about?
NCT02153918 is a clinical study titled "Vaccine Plus Booster Shots in Men With Prostate Cancer Undergoing Treatment With Radical Prostatectomy". 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 prost...
What is the current status of trial NCT02153918?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2014-05-31. Estimated completion is 2018-01-16.
What interventions are being tested in trial NCT02153918?
The interventions under investigation include: PROSTVAC-V/TRICOM (BIOLOGICAL), PROSTVAC-F/TRICOM (BIOLOGICAL).
Who is sponsoring clinical trial NCT02153918?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02153918's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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