Neoadjuvant Bevacizumab Plus Docetaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy
Condition: Prostate Cancer; Adenocarcinoma of the Prostate
MeSH terms: Prostatic Neoplasms
Intervention: Bevacizumab; Docetaxel
Intervention description: Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center.; Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.
Intervention MeSH terms: Bevacizumab; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostate cancer; bevacizumab; docetaxel; radical prostatectomy

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.
    

Eligibility criteria:

        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.