Neoadjuvant Bevacizumab Plus Docetaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy

Prostate Cancer Clinical Trial

Official title: A Phase II Study of Neoadjuvant Bevacizumab Plus Docetaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy

Status Completed

Clinical Trial Summary

The main purpose of this trial is to collect information and to evaluate the effects, good or bad, the combination of docetaxel and bevacizumab has on patients with high risk prostate cancer that are undergoing radical prostatectomy.

Clinical Trial Description

• Patients who are eligible for this study will undergo an endorectal MRI scan test before beginning the research study.

• After the MRI, the patient will begin the docetaxel plus bevacizumab part of the study. Each treatment cycle starts on the day you receive both drugs and lasts 21 days. Patients will undergo a total of 6 cycles-5 with docetaxel plus bevacizumab and one with docetaxel alone.

• At the beginning of each cycle, the patient will come into the clinic for a visit that will last about 3 hours. The following will happen at these visits: physical examination including vital signs and rectal exam; questions about the patients health and the medications they are taking; blood tests (both routine and research blood tests); urine tests; bevacizumab infusion; docetaxel infusion.

• The patients first dose of bevacizumab will be given on Day 1 of the first cycle over 90 minutes. If the patient tolerates the 90-minute infusion well, later doses may be given over a shorter period of time.

• The day before and the morning of the beginning of each cycle, the patient will be given a steroid called dexamethasone in pill form to help decrease the side effects of the treatment.

• The above tests and procedures will be repeated every 21 days a total of five times. For the sixth time, the patient will have all the same tests and procedures except they will not receive bevacizumab.

• After the six cycles, the patient will undergo another endorectal MRI.

• One to two months after finishing the sixth cycle, the patient will undergo a radical prostatectomy to remove their prostate.

• Two to three months after the surgery the patient will return to the clinic to have the following tests and procedures: questions about the patient's health; routine blood tests and research blood tests. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00321646
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Completed
• Phase: Phase 2
• Start date: June 2006
• Completion date: December 2012