Docetaxel Plus Capecitabine in Newly Diagnosed Localized or Locally Advanced Prostate Cancer

University of Michigan Rogel Cancer Center15 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Patients must have newly diagnosed prostate cancer with at least one of the following criteria: * Clinical Stage \> T2 * PSA \> 15 ng/ml * Biopsy Gleason's sum \> 8 * All patients must have a minimum PSA value of \> 5 ng/ml. * Patients may not have evidence of distant systemic metastasis. * Patients may not undergo concurrent hormonal, biologic, or chemotherapy. * Patients may not have prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil. * Patients with a history of severe reaction to docetaxel or other drugs formulated with polysorbate 80 will not be eligible. * Patients may not have an underlying cardiac disease.

Locations (2)

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Wayne State University

Detroit, Michigan, United States

Outcomes

Primary Outcomes

The percentage of patients who respond to treatment

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%.

Time frame: 6 months