A Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer

Protocol
07-041
Full Title
Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer (CALGB 90203)
Phase
III
Purpose

The purpose of this study is to compare the safety and effectiveness of giving chemotherapy and hormone therapy before radical prostatectomy (surgery to remove the prostate) to radical prostatectomy alone in men with previously untreated localized prostate cancer that has a high risk of returning after surgery. Patients will be randomly assigned to have surgery with or without preoperative docetaxel and hormonal therapy.

Researchers want to determine if chemotherapy and hormone therapy given before surgery improve the chance of a cure. They will also ask patients about their diet and lifestyle habits to see if they predict how well a patient fares.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of prostate cancer which has not spread (metastasized) to distant organs and has not yet been treated.
  • Patients’ prostate cancer must have a high risk of returning after surgery.
  • Patients must not be confined to a bed or chair for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information and to see if you are eligible for this study, please contact Dr. James Eastham at 646-422-4390.

Disease(s)
Prostate Cancer
Prostate Cancer: Localized Disease
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