Status and phase
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About
The purpose of this trial is to assess the effects of combined therapy with androgen ablation and OGX-011 (an antisense to clusterin) given prior to radical prostatectomy on pathologic complete response rates in men with localized prostate cancer and high risk features.
Full description
Clusterin as an anti-apoptotic cytoprotective chaperone protein upregulated in an adaptive cell survival manner that confers resistance to various cell death triggers, including hormone-, radiation-, and chemotherapy. In pre-clinical models, inhibition of clusterin expression using the second generation antisense OGX-011 can enhance cell death following treatment with androgen ablation, radiotherapy, and chemotherapy. In phase I clinical trials, OGX-011 has been well tolerated and a biologically effective dose has been identified in humans.
Study Design
This is an open-label, non-blinded, phase II clinical, tissue pharmacokinetic and pharmacodynamic study of weekly OGX-011 and neoadjuvant hormone therapy prior to radical prostatectomy in patients with localized prostate carcinoma and high-risk features.
Study Objectives
Primary Objectives
Secondary Objectives
Key Eligibility Criteria
Histologically confirmed adenocarcinoma of the prostate, previously untreated
Potential candidate for radical prostatectomy
Any one of the following criteria (minimum of 2 positive biopsies):
ECOG performance status 0-1
WBC ≥ 3.0 x 10^9/L
Hemoglobin ≥ 100 g/L
Platelets ≥ 100 x 10^9/L
PTT, INR, AST, ALT, creatinine, total bilirubin within normal limits
Treatment Plan
Approximately 45 newly diagnosed, previously untreated patients with clinically localized, high-risk prostate carcinoma will be entered into this trial. These patients will receive neoadjuvant hormone therapy (buserelin 9.9 mg subcutaneously x 1 injection with flutamide 250 mg orally T.I.D. for the first 4 weeks only) for 12 weeks in combination with OGX-011 (a 2'MOE phosphorothioate clusterin antisense oligonucleotide) weekly on a 4 week cycle for 3 courses. For week one, cycle one only, OGX-011 will be given on Days 1, 3 and 5. OGX-011 is given at a dose of 640 mg by intravenous infusion over 2 hours. Radical prostatectomy will take place within 14 days of the last dose of OGX-011.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Histologically confirmed adenocarcinoma of the prostate, previously untreated
Males ≥ 18 years of age.
Potential candidate for radical prostatectomy
Any of the following (minimum of 2 positive biopsies):
ECOG performance status 0-1
WBC ≥ 3.0 x 10^9/L
Hemoglobin ≥ 100 g/L
Platelets ≥ 100 x 10^9/L
PTT, INR, AST, ALT, creatinine, total bilirubin within normal limits
Patients must sign an informed consent that complies with US Regulations (US 21 Code of Federal Regulations [CFR]) and the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP) prior to undergoing treatment.
Exclusion criteria
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Data sourced from clinicaltrials.gov
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