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NCT00108732 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT00108732: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00108732 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00108732, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Androgens can cause the growth of prostate cancer cells. Drugs, such as bicalutamide and goserelin, may stop the adrenal glands from making androgens in patients whose tumor cells continue to grow. Giving vaccine therapy together with GM-CSF and, when needed, androgen ablation may be a more effective treatment for prostate cancer. This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with prostate cancer that progressed after surgery and/or radiation therapy.
Primary Outcome
For patients who achieved a \> 50% decline in PSA, an increase in PSA value by 50% over the nadir, confirmed by a second PSA two weeks later is considered progressive disease. The PSA rise must be at least 5 ng/mL or back to pretreatment baseline, whichever is greater. Changes in PSA below 5 ng/mL will not be considered assessable for progression. For patients whose PSA has not decreased by 50%, an increase in PSA value \> 50% of baseline (on trial) or nadir PSA, whichever is lower, confirmed
Interventions
- DRUG Bicalutamide
- DRUG Goserelin Acetate
- BIOLOGICAL Sargramostim
- BIOLOGICAL Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine
- BIOLOGICAL Recombinant Vaccinia-TRICOM Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2006-02 |
| Est. Completion | 2010-10 |
| Phase | Phase 2 |
What the finished NCT00108732 record still lists
NCT00108732 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 5 interventions - of which Bicalutamide is the first listed.
NCT00108732 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00108732 about?
NCT00108732 is a clinical study titled "A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer". Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Androgens can cause the growth of prostate cancer cells. Drugs...
What is the current status of trial NCT00108732?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2006-02. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00108732?
The interventions under investigation include: Bicalutamide (DRUG), Goserelin Acetate (DRUG), Sargramostim (BIOLOGICAL), Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine (BIOLOGICAL), Recombinant Vaccinia-TRICOM Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00108732?
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 NCT00108732's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 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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