drugset / Trial / NCT00870714

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

NCT00870714

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2004-09
Primary completion
2010-09
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 55 mg/m2 Intravenous
Subject Ketoconazole Small molecule 400 mg Oral

Indications