NCT00054106

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: Male
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	buserelin
DRUG	custirsen sodium
DRUG	flutamide
PROCEDURE	conventional surgery
PROCEDURE	neoadjuvant therapy

Timeline

• Start date: 2002-12-10
• Primary completion: 2004-09-23
• Completion: 2008-09-22
• First posted: 2003-02-06
• Last updated: 2023-08-04

Locations

1 site across 1 country: Canada