Study of OGX-011 Given Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer

NCT00138918 | Completed Phase 2

• 1 other identifier: R04-0092
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Clusterin; Neoadjuvant; Phase II

Outcome Measures

Primary Outcomes (1)

• 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

  See Detailed Description, Treatment Plan

Secondary Outcomes (7)

• To quantify changes in clusterin expression in residual prostate cancer after treatment with NHT and OGX-011

  See Detailed Description, Treatment Plan

• To measure levels of full length OGX-011 in prostate tissues after 3 months of NHT

  See Detailed Description, Treatment Plan

• To assess the safety and tolerability toxicity of 3 months of OGX-011 and NHT prior to radical prostatectomy

  See Detailed Description, Treatment Plan

• To measure evidence of OGX-011's effect on clusterin expression in patient peripheral blood mononuclear cells (PBMNC)

  See Detailed Description, Treatment Plan

• To measure evidence of OGX-011's effect on patient clusterin serum levels

  See Detailed Description, Treatment Plan

Interventions

OGX-011 BIOLOGICAL

See Detailed Description, Treatment Plan

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• United States Department of Defense: collaborator

Study Sites (1)

BC Cancer Agency and Vancouver General Hospital

Vancouver, British Columbia, V5Z 1L8, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

OGX-011

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Dr. Kim Chi

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 30, 2005
• Study Start: June 1, 2005
• Primary Completion: May 13, 2008
• Study Completion: May 13, 2008
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

CA (1)