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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Jacqueline Vuky, MD
Virginia Mason Medical Center
United States: Food and Drug Administration
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