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Pilot Phase II Trial of Bevacizumab in Combination With Hormonal and Radiotherapy in Patients With High-Risk Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

Pilot Phase II Trial of Bevacizumab in Combination With Hormonal and Radiotherapy in Patients With High-Risk Prostate Cancer

Although there is no data on the toxicity with concurrent bevacizumab and hormonal therapy,
the combination is not expected to increase toxicity seen when given as a single agent.
Abnormal tumor microenvironments, tumor progression, and metastatic spread are major factors
contributing to treatment failures in radiotherapy. Anti-VEGF agents (e.g. bevacizumab) can
help overcome these factors through several different mechanisims.

Studies also demonstrate prolonged use of anti-VEGF agents with radiation therapy was more
effective at preventing metastases from irradiated tumors compared to a short course.
Patients generally start hormonal therapy and daily radiotherapy at the same time. This
study will delay the start of radiotherapy until 8 weeks after the start of hormonal therapy
and bevacizumab.

Inclusion Criteria:

- High Risk Prostate Cancer as defined as ONE of the following:

1. Clinical T2b-T4

2. Gleason sum score 8-10

3. PSA more than 20 and Gleason sum score 7

4. In addition, clinical T2a patients are eligible if 5 or more biopsies contain
Gleason 4+3 cancer (minimum of 10 biopsies total required)

- No evidence of metastatic disease within 60 days of enrollment, confirmed by physical
examination, chest x-ray, bone scan, and computed tomography of the abdomen and

- ECOG performance status of 0, 1 or 2

Exclusion Criteria:

- Concurrent or prior treatment with radiation, cytotoxic, biologic therapy for
prostate cancer; any major surgery within four weeks, prior hormonal therapy (except
finasteride for obstructive voiding symptoms)

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0, anticipation of need for major surgical procedure during the course
of the study; Minor surgical procedures such as fine needle aspirations or core
biopsies within 7 days prior to Day 0

- Presence of central nervous system or brain metastases

- Blood pressure of >150/100 mmHg

- History of myocardial infarction within 6 months

- History of stroke within 6 months

- Current, recent (within 4 weeks of the first infusion of this study), or planned
participation in an experimental drug study other than a Genentech-sponsored
bevacizumab cancer study

Type of Study:


Study Design:

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

Outcome Measure:

To determine the acute (within 90 days from 1st day of radiation therapy) toxicities from intensity modulated radiation therapy (IMRT) in conjunction with bevacizumab, bicalutamide, and goserelin.

Principal Investigator

Jacqueline Vuky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Mason Medical Center


United States: Food and Drug Administration

Study ID:

BRI 3031500



Start Date:

April 2006

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • High-Risk Prostate Cancer
  • 1st line therapy
  • Prostatic Neoplasms



Virginia Mason Medical CenterSeattle, Washington  98111