Prospective Evaluation of Truebeam STX Stereotactic Body Radiosurgery for Low and Intermediate Risk Prostate Cancer
The prescribed PTV dose of 36.25Gy shall be given in 5 fractions using the Truebeam STx.
At one week after treatment, toxicity and AUA score will be evaluated. At 1 month following
treatment, patients will be assessed for acute toxicity, and will fill out AUA form, SF-12,
EPIC-26, SHIM and Utilization of Sexual Rx/Devices. At 3, 6, 12, 18, and 24 month intervals
(and every 6 months thereafter, through year 5, and annually through year 10, if
investigators opt to continue past year 5), patients will be seen and evaluated, including a
history, physical exam, ECOG performance status, PSA, toxicity evaluation, and AUA score. In
addition, at 6 months, 12 months and annually thereafter, the SF-12, EPIC-26, SHIM and
Utilization of Sexual Medications/Devices will be administered. Examination and studies may
be done at outside facility.
A prostate biopsy will be performed at time of biochemical or local clinical failure, and is
encouraged at 2 years following treatment and at time of distant failure.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
acute and late GI/GU toxicity rate following treatment
The study is designed to test the null hypothesis that the acute and late GI/GU toxicity rate 5 years following treatment is greater than 10% versus the alternative hypothesis that the toxicity rate is less than or equal to 10%. The sample size is determined such that there is 90% probability, or power, of identifying excessive toxicity if the true toxicity rate is 20% at the one-sided 5% significance level.
Albert DeNittis, MD
Lankenau Medical Center, Main Line Health
United States: Institutional Review Board
|Lankenau Medical Center, Radiation Oncology||Wynnewood, Pennsylvania 19096|