This is the classic website, which will be retired eventually. Please visit the modernized instead.
Working… Menu

Hormone Therapy and OGX-011 Before Radical Prostatectomy in Treating Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054106
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : August 4, 2023
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

Brief Summary:

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as flutamide and buserelin may stop the adrenal glands from producing androgens. OGX-011 may help flutamide and buserelin kill more tumor cells by making tumor cells more sensitive to the drugs. Giving flutamide and buserelin with OGX-011 before surgery may shrink the tumor so it can be removed during surgery.

PURPOSE: Phase I trial to study the effectiveness of combining hormone therapy with OGX-011 before radical prostatectomy in treating patients who have prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: buserelin Drug: custirsen sodium Drug: flutamide Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 1

Detailed Description:


  • Determine the maximum tolerated dose and recommended phase II dose of OGX-011 (clusterin antisense oligonucleotide) when administered with neoadjuvant hormonal therapy before radical prostatectomy in patients with adenocarcinoma of the prostate.
  • Determine the toxicity of this regimen in these patients.
  • Determine the pharmacokinetics of OGX-011 when this regimen is administered in these patients..
  • Assess the effects of this regimen on pathologic complete response rates in these patients.
  • Correlate plasma and/or prostate concentrations of OGX-011 with patient response or toxicity measures.

OUTLINE: This is a dose-escalation study of OGX-011.

Patients receive OGX-011 IV over 2 hours on days 1, 3, 5, 8, 15, 22, and 29; oral flutamide three times daily for 4 weeks; and buserelin subcutaneously on day 1.

Cohorts of 3-6 patients (except for 1 patient at starting dose) receive escalating doses of OGX-011 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The recommended phase II dose is the dose preceding the MTD.

Patients undergo radical prostatectomy and bilateral pelvic lymphadenectomy 1 week after the last dose of neoadjuvant therapy.

Patients are followed at 7 days after surgery and then at 3 months.

PROJECTED ACCRUAL: Approximately 25-33 patients will be accrued for this study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study Of Combination Neoadjuvant Hormone Therapy And Weekly OGX-011 (Clusterin Antisense Oligonucleotide) Prior To Radical Prostatectomy In Patients With Localized Prostate Cancer
Actual Study Start Date : December 10, 2002
Actual Primary Completion Date : September 23, 2004
Actual Study Completion Date : September 22, 2008

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate

    • High-risk, localized disease that is previously untreated
    • Minimum of 2 positive biopsies
    • Meets at least 1 of the following criteria:

      • Stage T3
      • Serum PSA greater than 10 ng/mL
      • Gleason score 7-10
      • Gleason score 6 and at least 3 positive biopsies
  • Potential candidate for radical prostatectomy



  • Over 18

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10.0 g/dL


  • Bilirubin normal
  • AST and ALT normal
  • PTT normal
  • INR normal


  • Creatinine normal


  • No significant cardiac dysfunction


  • Fertile patients must use effective contraception
  • No known hypersensitivity to oligonucleotides, luteinizing hormone-releasing hormone analogs, or anti-androgens
  • No evidence of active uncontrolled infection
  • No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer
  • No other serious illness, psychiatric disorder, or medical condition that would preclude study compliance
  • No history of a significant neurological disorder that would preclude informed consent
  • No geographical condition that would preclude study compliance


Biologic therapy

  • Not specified


  • No prior chemotherapy for prostate cancer

Endocrine therapy

  • No prior hormonal therapy for prostate cancer


  • No prior radiotherapy for prostate cancer
  • No concurrent radiotherapy


  • Not specified


  • No concurrent heparin or warfarin anticoagulation
  • No other concurrent investigational therapy
  • No other concurrent cytotoxic therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00054106

Layout table for location information
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
NCIC Clinical Trials Group
Layout table for investigator information
Study Chair: Kim N. Chi, MD British Columbia Cancer Agency
Publications of Results:
Chi KN, Eisenhauer E, Fazli L, et al.: A phase I pharmacokinetic (PK) and pharmacodynamic (PD) study of OGX-011, a 2'methoxyethyl phosphorothioate antisense to clusterin, in patients with prostate cancer prior to radical prostatectomy. [Abstract] J Clin Oncol 22 (Suppl 14): A-3033, 203s, 2004.

Layout table for additonal information
Responsible Party: NCIC Clinical Trials Group Identifier: NCT00054106    
Other Study ID Numbers: I153
CAN-NCIC-IND153 ( Other Identifier: PDQ )
ONCOGENEX-OGX-01-01 ( Other Identifier: Oncogenex Technologies )
CDR0000269888 ( Other Identifier: PDQ )
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: August 4, 2023
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Canadian Cancer Trials Group ( NCIC Clinical Trials Group ):
adenocarcinoma of the prostate
stage III prostate cancer
stage II prostate cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents