Development of a Phase I/II Clinical Trial Using Sterotactic Body Radiation Therapy (SBRT) for the Treatment of Localized Prostate Carcinoma

摘要

Stereotactic body radiation therapy (SBRT) is a new therapeutic paradigm for treating localized tumors outside of the central nervous system and involves delivering very high doses of focused radiation using unique beam arrangements and special immobilization equipment. It has also been shown recently that many prostate cancers may be better controlled using large dose per fraction treatments such as might be delivered by SBRT. While large dose per fraction treatments are facilitated by new generation radiation delivery equipment, technology cannot independently overcome normal tissue consequences to tubular organs adjacent or within targets (e.g., the urethra and rectum for prostate cancer). As such, careful prospective clinical trials must be designed that appropriate bridge the information learned from laboratory testing, historical clinical experience, and the clinical experience with SBRT from other sites in order to test this new therapy for prostate cancer. Our goal is ultimately to carry out a prospective phase I/II trial of SBRT for treatment of localized prostate cancer such that its true efficacy and toxicity might be characterized. The objective of this application is to establish the collaborations necessary for formulating these protocols, write the protocols, assemble the clinical research infrastructure necessary for submitting the protocols, set up mechanisms for multi-center participation with our center acting as the coordinating center, recruiting, enrolling, treating and following patients, and to support the research infrastructure and clinical researchers performing these tasks.