NCT02111187

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

A Pharmacodynamic Pre-surgical Study of Hedgehog Pathway Inhibition With LDE225 in Men With High-risk Localized Prostate Cancer.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Male
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

High-risk patients will be identified based on their core-needle biopsy features, PSA levels, and clinical stage. After obtaining baseline laboratory and clinical values (including an ECG, PSA, hematologic, and renal and hepatic panels), men will receive oral LDE225 800 mg/day or observation daily for 4 weeks (±3 days) prior to prostatectomy. Patients will have a clinical visit and an ECG and laboratory testing will be performed at 2 weeks and then again at 4 weeks, including a 4-week pre-prostatectomy measurement of PSA and a blood sample to determine plasma LDE225 levels. Men will undergo radical prostatectomy (with bilateral pelvic lymphadenectomy as appropriate), at which point two 250-mg biopsies of prostate tissue will be obtained, frozen and stored for analysis.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	LDE225	Sonidegib was given as an oral drug at 800mg daily for 28 days prior to prostetoctomy

Timeline

• Start date: 2014-04-01
• Primary completion: 2017-01-18
• Completion: 2017-01-18
• First posted: 2014-04-11
• Last updated: 2019-03-07
• Results posted: 2019-03-07

Locations

1 site across 1 country: United States