A Pre-surgical Study of LDE225 in Men With High-risk Localized Prostate Cancer (LDE225)
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|ClinicalTrials.gov Identifier: NCT02111187|
Recruitment Status : Completed
First Posted : April 11, 2014
Results First Posted : March 7, 2019
Last Update Posted : March 7, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: LDE225||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pharmacodynamic Pre-surgical Study of Hedgehog Pathway Inhibition With LDE225 in Men With High-risk Localized Prostate Cancer.|
|Actual Study Start Date :||April 2014|
|Actual Primary Completion Date :||January 18, 2017|
|Actual Study Completion Date :||January 18, 2017|
Active Comparator: LDE225 (Arm1)
Treatment arm (Arm 1) will receive LDE225 by mouth 800 mg daily for 4 weeks (+/- 3 days)
Sonidegib was given as an oral drug at 800mg daily for 28 days prior to prostetoctomy
Other Name: Sonidegib
No Intervention: Observation Arm (Arm2)
Observation Arm (Arm2) will receive no treatment prior to prostatectomy.
- Change From Baseline in Tissue Gli1 Expression Levels Using qRT-PCR Analysis in Each Group (LDE225 and Observation) [ Time Frame: Up to 3 Years ]This was defined as the number of patients who achieved at least a two-fold reduction in GLI1 expression in post-treatment vs. pre-treatment tumor tissues.
- Percentage of Participants With a Pathological Effect of Presurgical Treatment With LDE225 [ Time Frame: Up to 3 years ]To determine whether presurgical treatment with LDE225 can exert a pathological effect on high-risk tumors (i.e. increase apoptosis, decrease proliferation).
- Effect of LDE225 on PSA Recurrence Following Prostatectomy [ Time Frame: Up to 3 years ]To evaluate whether presurgical treatment with LDE225 diminishes the risk of PSA recurrence following prostatectomy.
- Number of Participants With Adverse Events in Each Group (LDE225 and Observation) [ Time Frame: Up to 3 years ]Safety and tolerability, including any drug-related toxicities of Sonidegib, were reported via CTCAE version 4.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111187
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Emmanuel Antonarakis, M.D.||Johns Hopkins University|