Evaluation of Primary Chemotherapy With Docetaxel Plus Capecitabine in Selected Patients With Newly Diagnosed Localized or Locally Advanced Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- Capecitabine
- Conditions
- Prostate Cancer
- Sponsor
- University of Michigan Rogel Cancer Center
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- The percentage of patients who respond to treatment
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Docetaxel and Capecitabine
Intervention: Capecitabine
Docetaxel and Capecitabine
Intervention: Docetaxel
Outcomes
Primary Outcomes
The percentage of patients who respond to treatment
Time Frame: 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%.