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NCT01867333 · ClinicalTrials.gov registry record · Phase 2
Enzalutamide With or Without Vaccine Therapy for Advanced Prostate Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT01867333: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01867333 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 57 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01867333, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
Background: \- Enzalutamide is a hormone therapy that is used to treat advanced prostate cancer. It is given after chemotherapy and surgery to help the body destroy the cancer cells. A new possible way of treating prostate cancer is using a vaccine that may help stimulate the immune system. It will help white blood cells recognize and kill the cancer cells in and around the prostate. Researchers want to see whether this vaccine, given with enzalutamide, is more effective at treating advanced prostate cancer than enzalutamide alone. Objectives: \- To compare the safety and effectiveness of enzalutamide with and without vaccine therapy for advanced prostate cancer. Eligibility: \- Men at least 18 years of age who have advanced castration-resistant prostate cancer. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies will be used to monitor the cancer before treatment. * Participants will be separated into two groups. One group will have enzalutamide and the study vaccine. The other group will have enzalutamide alone. * All participants will take enzalutamide once a day. They will take the drug during 4-week cycles of treatment. * Treatment will be monitored with frequent blood tests and imaging studies. Participants will continue to take the study drug for as long as the cancer does not grow, and the side effects are not severe. * The vaccine group of participants will also have the new study vaccine. They will have a single injection on the first day of the first study cycle. There will be regular booster injections afterward. There will be one on day 15 of the first cycle, the first day of the second cycle. The vaccine will then be given every 4 weeks for the next four cycles, and then every 12 weeks (every 3 cycles) thereafter. Participants will continue to have the study vaccine for as long as the cancer does not grow, and the side effects are not severe.
Interventions
- BIOLOGICAL Enzalutamide
- BIOLOGICAL PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -F/TRICOM
- BIOLOGICAL PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -V/TRICOM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2013-08-12 |
| Est. Completion | 2022-10-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01867333
The ClinicalTrials.gov registry entry for NCT01867333 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Enzalutamide is the first listed.
NCT01867333 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01867333 about?
NCT01867333 is a clinical study titled "Enzalutamide With or Without Vaccine Therapy for Advanced Prostate Cancer". Background: \- Enzalutamide is a hormone therapy that is used to treat advanced prostate cancer. It is given after chemotherapy and surgery to help the body destroy the cancer cells. A new possible way of treating prostate cancer is using a vaccine that may help stimulate the immune system. It will...
What is the current status of trial NCT01867333?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2013-08-12. Estimated completion is 2022-10-26.
What interventions are being tested in trial NCT01867333?
The interventions under investigation include: Enzalutamide (BIOLOGICAL), PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -F/TRICOM (BIOLOGICAL), PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -V/TRICOM (BIOLOGICAL).
Who is sponsoring clinical trial NCT01867333?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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