Status:
COMPLETED
Study of OGX-011 Given Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
United States Department of Defense
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
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 respon...
Detailed 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-, ...
Eligibility Criteria
Inclusion
- 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):
- Clinical stage T3
- Serum PSA \> 10 ng/ml
- Gleason score 7-10
- Gleason score 6 and \> 3 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
- Prior hormone, radiation, or chemotherapy for prostate cancer
- Evidence of active infection
- Patients receiving therapeutic doses of warfarin or heparin
- Severe end organ disease
- Patients who otherwise would not be candidates for radical prostatectomy because of health or tumour factors
- Patients will be excluded if they had any prior malignancy unless the prior malignancy was diagnosed and definitively treated at least five years previously and there has never been any evidence of recurrence.
- Other serious illness, psychiatric, or medical condition that would not permit the patient to be managed according to the protocol.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00138918
Start Date
June 1 2005
End Date
May 13 2008
Last Update
March 3 2017
Active Locations (1)
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1
BC Cancer Agency and Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1L8