Phase 1
N=14
A Pre-surgical Study of LDE225 in Men With High-risk Localized Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02111187 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Change From Baseline in Tissue Gli1 Expression Levels Using qRT-PCR Analysis in Each Group (LDE225 and Observation) — 6; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LDE225 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Tissue Gli1 Expression Levels Using qRT-PCR Analysis in Each Group (LDE225 and Observation) |
6; 0 | — |
| SECONDARY Percentage of Participants With a Pathological Effect of Presurgical Treatment With LDE225 |
1; 1; 5; 6; 1; 0 | — |
| SECONDARY Effect of LDE225 on PSA Recurrence Following Prostatectomy |
12.0; 7.4 | — |
| SECONDARY Number of Participants With Adverse Events in Each Group (LDE225 and Observation) |
3; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Provide written informed consent prior to any screening procedures.
- Age 18 years or older.
- Histologically-documented prostatic adenocarcinoma in ≥2 cores
- ECOG performance status ≤2
- Localized prostate cancer with at least one of the following NCCN high-risk features:
- Gleason sum ≥8
- PSA >20 ng/mL
- Clinical stage ≥T3
- Must be a candidate for radical prostatectomy
- No evidence of known metastatic disease (M0 or Mx allowed)
- Adequate bone marrow, liver and renal function as specified below:
- Absolute neutrophil count (ANC) ≥ 1500/µL
- Hemoglobin (Hgb) ≥ 9.0 g/dL
- Platelets ≥100,000/µL
- Serum total bilirubin ≤ 1.5 x ULN (upper limit of normal)
- AST and ALT ≤ 2.5 x ULN
- Plasma creatine phosphokinase (CK) 450 msec on the screening ECG
- A past medical history of clinically significant ECG abnormalities or a family history of prolonged QT-interval syndrome
- Other clinically significant heart disease (e.g. heart failure, uncontrolled/labile hypertension, or history of poor compliance with an antihypertensive regimen)
- Patients who are not willing to apply highly effective contraception during the study and through the duration of LDE225 treatment.
- Male patients must use highly effective (double barrier) methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and continuing using contraception and refrain from fathering a child for 6 months following the last dose of the study drug. A condom is also required to be used by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the study treatment via seminal fluid. Sexually active males must be willing to use a condom during intercourse while taking the study drug and for 6 months after stopping investigational medications and agree not to father a child during this period.
- Patients unwilling or unable to comply with the research protocol.
Data sourced from ClinicalTrials.gov (NCT02111187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.