Docetaxel Plus Capecitabine in Newly Diagnosed Localized or Locally Advanced Prostate Cancer
- Registration Number
- NCT00151047
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- Brief Summary
Purpose: The purpose of this clinical trial is to look at the chemotherapy combination of docetaxel and capecitabine in the treatment of newly diagnosed or locally advanced prostate cancer, and to determine if this treatment is an acceptable, effective and a safe treatment option. In addition, this clinical trial will evaluate how this treatment affects chemicals (enzymes), and other cancer related genetic changes in the tumor. Optional: This clinical trial will conduct extra imaging studies for research purposes including combined endorectal prostate magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRSI) and diffusion weighted imaging (DWI) to evaluate prostate cancer and response to study treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Docetaxel and Capecitabine Docetaxel - Docetaxel and Capecitabine Capecitabine -
- Primary Outcome Measures
Name Time Method The percentage of patients who respond to treatment 6 months To evaluate the response rate associated with capecitabine and docetaxel combination chemotherapy in selected patients with localized or locally advanced prostate cancer. Response is defined as a reduction in the PSA (Prostate Specific Antigen) by at least 50%.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Wayne State University
🇺🇸Detroit, Michigan, United States
The University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States