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Neoadjuvant Leuvectin in Prostate Cancer
NCT00004050Phase 2
Key facts
- Status
- Terminated
- Start
- Jun 1999
- Primary completion
- Apr 2003
- Countries
- 1
- Sponsor
- Vical Incorporated
- Modality
- Gene Editing, Prophylactic Vaccines, Gene Silencing
- Drugs
- Leuvectin
- Conditions
- prostate cancer (PCa)
01
Overview
Phase 2, open-label, single-arm trial of Leuvectin in prostate cancer (PCa), sponsored by Vical Incorporated. Primary endpoint: Disease recurrence at 2 years. Started Jun 1999; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Leuvectin
Neoadjuvant Leuvectin followed by surgery
03
Who it enrols
Patients with histologically confirmed stage II or III organ confined prostate cancer who are candidates for radical prostatectomy, with Gleason score >= 6 and PSA >= 5 ng/mL.
04
Endpoints
Primary
Disease recurrence
Secondary
Safety of Leuvectin
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