Study of OGX-011 Given Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer
This study is currently recruiting participants.
Verified April 2012 by University of British Columbia
Sponsor:
University of British Columbia
Collaborator:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00138918
First received: August 26, 2005
Last updated: April 24, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: OGX-011 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of OGX-011 Given Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by University of British Columbia:
Primary Outcome Measures:
- To assess the effects of combined neoadjuvant hormone therapy (NHT) and OGX-011 prior to radical prostatectomy on pathologic complete response rates in men with high risk localized prostate cancer [ Time Frame: See Detailed Description, Treatment Plan ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To quantify changes in clusterin expression in residual prostate cancer after treatment with NHT and OGX-011 [ Time Frame: See Detailed Description, Treatment Plan ] [ Designated as safety issue: No ]
- To measure levels of full length OGX-011 in prostate tissues after 3 months of NHT [ Time Frame: See Detailed Description, Treatment Plan ] [ Designated as safety issue: No ]
- To assess the safety and tolerability toxicity of 3 months of OGX-011 and NHT prior to radical prostatectomy [ Time Frame: See Detailed Description, Treatment Plan ] [ Designated as safety issue: No ]
- To measure evidence of OGX-011's effect on clusterin expression in patient peripheral blood mononuclear cells (PBMNC) [ Time Frame: See Detailed Description, Treatment Plan ] [ Designated as safety issue: No ]
- To measure evidence of OGX-011's effect on patient clusterin serum levels [ Time Frame: See Detailed Description, Treatment Plan ] [ Designated as safety issue: No ]
- To assess the effects of combined NHT and OGX-011 on time to prostate specific antigen (PSA) nadir [ Time Frame: See Detailed Description, Treatment Plan ] [ Designated as safety issue: No ]
- To determine PSA recurrence rates after combined NHT and OGX-011 [ Time Frame: See Detailed Description, Treatment Plan ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Biological: OGX-011
See Detailed Description, Treatment Plan
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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):
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00138918
Contacts
| Contact: Susan D'Aloisio | (604) 877-6000 |
Locations
| Canada, British Columbia | |
| BC Cancer Agency and Vancouver General Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 1L8 | |
| Contact: Susan D'Aloisio | |
| Principal Investigator: Dr. Kim Chi | |
Sponsors and Collaborators
University of British Columbia
Investigators
| Principal Investigator: | Dr. Kim Chi | University of British Columbia |
More Information
No publications provided
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00138918 History of Changes |
| Other Study ID Numbers: | R04-0092 |
| Study First Received: | August 26, 2005 |
| Last Updated: | April 24, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
Prostate Cancer Clusterin Neoadjuvant Phase II |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013