Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer
This is a single site, non-randomized, prospective, phase IV trial of patients with
organ-confined prostate cancer. Data collected will include patient demographics, pathology
data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal
tissues,tumor recurrence data, and acute and late toxicities. Follow up data will be
collected during the patient's standard office visits. The anticipated duration of this
study is 5 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Biochemical control rate
Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular intervals.The "Phoenix definition" for biochemical recurrence (nadir + 2 ng/ml) will be used.
United States: Institutional Review Board
|Mercy Hospital St. Louis||St. Louis, Missouri 63141|