Conditions: Prostate Cancer
Keywords: prostate
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 49
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the effectiveness of two drugs, docetaxel and Gleevec®(also called imatinib), in prostate cancer that no longer responds to hormone therapy. The investigators are interested in finding out if the combination of these two drugs is more effective than docetaxel alone in the treatment of prostate cancer.

Detailed description:
This is a non-randomized multicenter Phase II trial of Gleevec and docetaxel in chemo naïve metastatic hormone refractory prostate cancer. The primary objective of this study is to assess the time to disease progression in patients with hormone refractory prostate cancer treated with daily oral imatinib and intravenous docetaxel, administered every three weeks. Secondary objectives include: 1) to assess the rate of response to imatinib and docetaxel, using Prostate Specific Antigen (PSA) and/or measurable disease; 2) to assess the overall survival of patients with hormone refractory prostate cancer treated with imatinib and docetaxel; and 3) to evaluate the qualitative and quantitative toxicities of this combination.

Arms:
arm 1: Gleevec + Docetaxel: Daily Oral Gleevec in Combination with Every-Three-Week Intravenous Docetaxel

Interventions: intervention 1: Gleevec intervention 2: Docetaxel
Intervention descriptions: intervention 1: Imatinib-400mg po qd for 10 days to commence on day 3. On day 0, Docetaxel 60mg/m\^2 administered IV intervention 2: 60 mg/m\^2 administered IV on day 0

Protocol document: