Prostate Cancer Clinical Trial

Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer

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).

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Full Description

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.

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Eligibility Criteria

Inclusion Criteria:

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

Clinical T2b-T4
Gleason sum score 8-10
PSA more than 20 and Gleason sum score 7
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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

18

Study ID:

NCT00349557

Recruitment Status:

Completed

Sponsor:

Benaroya Research Institute

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There is 1 Location for this study

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Virginia Mason Medical Center
Seattle Washington, 98101, United States

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Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

18

Study ID:

NCT00349557

Recruitment Status:

Completed

Sponsor:


Benaroya Research Institute

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