Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine the acute and late toxicities from radiation therapy in combination with bevacizumab (given every 2 weeks for 16 weeks then every 3 weeks for 12 weeks), bicalutamide (every day for 16 weeks) and goserelin (every 3 months for 2 years).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Benaroya Research Institute
• Collaborator: Genentech, Inc.
• Treatments: Bevacizumab; Bicalutamide; Goserelin

Criteria

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 pelvis

• 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