NCT00870714

Neoadjuvant Therapy With Docetaxel and Ketoconazole in Patients With High-Risk Prostate Cancer: A Pilot Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Kansas City Veteran Affairs Medical Center · Federal
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Eligible patients with high-risk prostate cancer who are scheduled to undergo radical prostatectomy will receive four cycles of therapy with ketoconazole and docetaxel prior to surgery resection. A cycle of therapy is defined as 21 days (three weeks). Pharmacokinetic analysis will be performed with the first and second cycle of therapy. All patients will be evaluated for toxicity, tumor response, and recurrence.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel 55mg/m2 to be given IV as a one-hour infusion to be repeated every 21 days for four treatment cycles.
DRUG	Ketoconazole	Ketoconazole 400mg P.O. BID daily to start on day 2 following the first docetaxel treatment. In patients who experience no grade 2 or higher toxicity, the ketoconazole dose will be increased to 400mg TID on day 2 following cycle #2 of docetaxel. This will be continued daily until completion of study treatment.

Timeline

• Start date: 2004-09-01
• Primary completion: 2010-09-01
• First posted: 2009-03-27
• Last updated: 2009-03-27

Locations

1 site across 1 country: United States