drugset / Trial / NCT02111187

A Pre-surgical Study of LDE225 in Men With High-risk Localized Prostate Cancer

NCT02111187

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

EvaluationDrugModalityDoseRoute
Comparator Sonidegib Small molecule 800 mg Oral

Indications