drugset / Trial / NCT02111187
A Pre-surgical Study of LDE225 in Men With High-risk Localized Prostate Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is designed as a randomized two-arm (LDE225 vs. observation groups) open-label prospective clinical trial in men with localized high-risk prostate cancer undergoing radical prostatectomy. The investigators propose to determine the effects of LDE225 on neoplastic prostate tissue from men at high risk of systemic disease progression, by comparing pre-surgical core-biopsy specimens to tumor tissue harvested at the time of prostatectomy.
Timeline
- Start
- 2014-04
- Primary completion
- 2017-01-18
- Completion
- 2017-01-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sonidegib | Small molecule | 800 mg | Oral |