Spots Global Cancer Trial Database for Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer

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Trial Identification

Brief Title: Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer

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

Study ID: NCT00349557

Conditions

Prostate Cancer

Interventions

bevacizumab, bicalutamide and goserelin

intensity modulated radiation therapy (IMRT)

Study Description

Brief 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).

Detailed 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.