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

Phase 2
18 Years
Not Enrolling
Prostate Cancer, Adenocarcinoma of the Prostate

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Trial Information

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 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.

Inclusion Criteria:

- Histological documentation of adenocarcinoma of the prostate, with available biopsy
pathology. Material from this biopsy must be available for central review at DF/HCC
by the beginning of the second cycle of therapy.

- Potential candidate for radical prostatectomy

- Must meet one or more of the below characteristics: Gleason score of 8, 9 or 10;
serum PSA of greater than or equal to 20 ng/mL; clinical T stage of T3; PSA velocity
of greater than or equal to 2ng/mL/year in the year prior to diagnosis; Gleason score
of 7 and erMRI T3 disease; Greater than or equal to 50% of the total number of biopsy
cores positive for prostate cancer and either PSA > 10ng/mL or Gleason score of 7 or
clinical T stage of T2a, T2b or T2c.

- Greater than six weeks since any major surgery

- Serum testosterone > 100ng/dL

- ECOG Performance Status of 0 or 1

- ANC > 1,500/ul

- Platelets > 100,000/ul

- Total bilirubin, alkaline phosphatase, AST and ALT within normal limits

- Creatinine < 2.0 x upper limit of normal

Exclusion Criteria:

- History of prior radiation, surgery or hormonal therapy treatment for prostate cancer

- Clinical evidence of metastatic prostate cancer

- Ongoing oral steroid use

- Pre-existing neuropathy of grade 2 or greater

- Severe claustrophobia, inability to lie still in a magnet for 60 minutes, a
pacemaker, or any other condition that would preclude proximity to a strong magnet.

- History of the following conditions: unstable angina; symptomatic, clinically
significant peripheral vascular disease; NY Heart Association Grade 2 or greater
heart failure; uncontrolled hypertension; myocardial infarction or stroke < 12 months
prior to enrollment; uncontrolled hypertension; active, uncontrolled infection;
history of DVT, PE or known coagulopathy or bleeding diathesis; ongoing us of
anticoagulant therapy; history of abdominal fistulas, GI perforation, or
intra-abdominal abscess within 6 months prior to study entry; non-healing ulcer or
fracture; history of another malignancy diagnosed within the last five years; spot
urine protein: creatinine ratio > 1.0 at screening.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the efficacy of bevacizumab plus docetaxel in the neoadjuvant treatment of men with localized, high-rish prostate cancer.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Mary-Ellen Taplin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

June 2006

Completion Date:

December 2012

Related Keywords:

  • Prostate Cancer
  • Adenocarcinoma of the Prostate
  • prostate cancer
  • bevacizumab
  • docetaxel
  • radical prostatectomy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Duke University Medical Center Durham, North Carolina  27710