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NCT02649439 · ClinicalTrials.gov registry record · Phase 2
Prostvac in Patients With Biochemically Recurrent Prostate Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
NCT02649439: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT02649439 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 97 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02649439, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 97 participants
- Enrollment target
Study Summary
Background: Some people who have been treated for prostate cancer still have high prostate-specific antigen (PSA) levels. This may indicate cancer. These people have non-metastatic castration sensitive prostate cancer (nmCSPC) or biochemical recurrent prostate cancer. Researchers think the immune system can be taught to fight and kill cancer cells. They think an immunotherapy vaccine called prostvac could help reduce PSA levels in people with this type of prostate cancer. Objective: To test if prostvac can decrease tumor growth rate as measured by PSA compared to getting surveillance alone. Eligibility: Men ages 18 or older who have nmCSPC or biochemical recurrent prostate cancer Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Bone scan Computed tomography (CT) scan, or magnetic resonance imaging (MRI) and positron emission tomography (PET) scan: They lie in a machine that takes pictures of the body. Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals. Participants will be part of 1 of 2 arms: Arm A will get prostvac for 6 months. Arm B will have surveillance for 6 months followed by prostvac for 6 months. During the prostvac period, participants will get prostvac as a shot under the skin on weeks 1, 3, and 5, and then monthly for a total of 5 months. Participants will have follow-up visits at least every month until they recover from prostvac side effects or their cancer worsens. Visits may include repeats of screening tests. Participants will be followed for up to 15 years. They will have a physical exam every year for the first 5 years. They will have phone calls once a year.
Interventions
- BIOLOGICAL PROSTVAC-F
- BIOLOGICAL PROSTVAC -V
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2015-12-22 |
| Est. Completion | 2022-10-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02649439
The ClinicalTrials.gov registry entry for NCT02649439 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 97 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 2 interventions - of which PROSTVAC-F is the first listed.
NCT02649439 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02649439 about?
NCT02649439 is a clinical study titled "Prostvac in Patients With Biochemically Recurrent Prostate Cancer". Background: Some people who have been treated for prostate cancer still have high prostate-specific antigen (PSA) levels. This may indicate cancer. These people have non-metastatic castration sensitive prostate cancer (nmCSPC) or biochemical recurrent prostate cancer. Researchers think the immune s...
What is the current status of trial NCT02649439?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2015-12-22. Estimated completion is 2022-10-01.
What interventions are being tested in trial NCT02649439?
The interventions under investigation include: PROSTVAC-F (BIOLOGICAL), PROSTVAC -V (BIOLOGICAL).
Who is sponsoring clinical trial NCT02649439?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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