Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00138918
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2005-08-26
Brief Title:
Study of OGX-011 Given Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
A Phase II Study of OGX-011 Given Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 response rates in men with localized prostate cancer and high risk features
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- 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
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
Secondary Objectives
To quantify changes in clusterin expression in residual prostate cancer after treatment with NHT and OGX-011
To measure levels of full length OGX-011 in prostate tissues after 3 months of NHT
To assess the safety and tolerability toxicity of 3 months of OGX-011 and NHT prior to radical prostatectomy
To measure evidence of OGX-011s effect on clusterin expression in patient peripheral blood mononuclear cells PBMNC
To measure evidence of OGX-011s effect on patient clusterin serum levels
To assess the effects of combined NHT and OGX-011 on time to PSA nadir
To determine PSA recurrence rates after combined NHT and OGX-011
Key Eligibility Criteria
1 Histologically confirmed adenocarcinoma of the prostate previously untreated
2 Potential candidate for radical prostatectomy
3 Any one of the following criteria minimum of 2 positive biopsies
Clinical stage T3
Serum PSA 10 ngml
Gleason score 7-10
Gleason score 6 and 3 positive biopsies
4 ECOG performance status 0-1
5 WBC 30 x 109L
6 Hemoglobin 100 gL
7 Platelets 100 x 109L
8 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 99 mg subcutaneously x 1 injection with flutamide 250 mg orally TID for the first 4 weeks only for 12 weeks in combination with OGX-011 a 2MOE 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
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
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
Secondary Objectives
To quantify changes in clusterin expression in residual prostate cancer after treatment with NHT and OGX-011
To measure levels of full length OGX-011 in prostate tissues after 3 months of NHT
To assess the safety and tolerability toxicity of 3 months of OGX-011 and NHT prior to radical prostatectomy
To measure evidence of OGX-011s effect on clusterin expression in patient peripheral blood mononuclear cells PBMNC
To measure evidence of OGX-011s effect on patient clusterin serum levels
To assess the effects of combined NHT and OGX-011 on time to PSA nadir
To determine PSA recurrence rates after combined NHT and OGX-011
Key Eligibility Criteria
1 Histologically confirmed adenocarcinoma of the prostate previously untreated
2 Potential candidate for radical prostatectomy
3 Any one of the following criteria minimum of 2 positive biopsies
Clinical stage T3
Serum PSA 10 ngml
Gleason score 7-10
Gleason score 6 and 3 positive biopsies
4 ECOG performance status 0-1
5 WBC 30 x 109L
6 Hemoglobin 100 gL
7 Platelets 100 x 109L
8 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 99 mg subcutaneously x 1 injection with flutamide 250 mg orally TID for the first 4 weeks only for 12 weeks in combination with OGX-011 a 2MOE 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None