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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of British Columbia.
Recruitment status was  Recruiting
Sponsor:
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
  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:

  1. Histologically confirmed adenocarcinoma of the prostate, previously untreated
  2. Males ≥ 18 years of age.
  3. Potential candidate for radical prostatectomy
  4. 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
  5. ECOG performance status 0-1
  6. WBC ≥ 3.0 x 10^9/L
  7. Hemoglobin ≥ 100 g/L
  8. Platelets ≥ 100 x 10^9/L
  9. PTT, INR, AST, ALT, creatinine, total bilirubin within normal limits
  10. 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:

  1. Prior hormone, radiation, or chemotherapy for prostate cancer
  2. Evidence of active infection
  3. Patients receiving therapeutic doses of warfarin or heparin
  4. Severe end organ disease
  5. Patients who otherwise would not be candidates for radical prostatectomy because of health or tumour factors
  6. 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.
  7. Other serious illness, psychiatric, or medical condition that would not permit the patient to be managed according to the protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014