Evaluation of Primary Chemotherapy With Docetaxel Plus Capecitabine in Selected Patients With Newly Diagnosed Localized or Locally Advanced Prostate Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- The percentage of patients who respond to treatment
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Docetaxel and Capecitabine
Intervention: Capecitabine (Drug)
Docetaxel and Capecitabine
Intervention: Docetaxel (Drug)
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%.
Secondary Outcomes
No secondary outcomes reported