A Phase II Study of Neoadjuvant Bevacizumab Plus Docetaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy
- 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 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the efficacy of bevacizumab plus docetaxel in the neoadjuvant treatment of men with localized, high-rish prostate cancer.
Mary-Ellen Taplin, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Duke University Medical Center||Durham, North Carolina 27710|