The primary safety purpose of this study is to estimate the rates of immediate and long-term high grade (grade 3-5) gastrointestinal and genitourinary side effects during the five years after TrueBeam stereotactic body radiotherapy in low-risk and intermediate-risk prostate cancer patients. The primary efficacy purpose is to compare 5 year biochemical disease free survival rates with TrueBeam to 5 year biochemical diseases free survival rates with dose-escalated external beam radiation therapy.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
36.25Gy to be delivered to the prostate in 5 fractions. There is only 1 arm in this study.
Lankenau Medical Center, Radiation Oncology
Wynnewood, Pennsylvania, United States
RECRUITINGacute 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.
Time frame: 5 years
a comparison of biochemical disease free survival in low risk patients treated with TrueBeam compared to (historical) biochemical disease free survival in patients treated with dose-escalated external beam radiation therapy
For the low-risk cohort, the study is powered to compare 5-year bDFS rates observed with TrueBeam STx to 5-year bDFS rates reported with dose-escalated external beam RT. In Beaumont's monotherapy HDR series treating LR patients, 5-yr ASTRO bDFS was 98%; in Demanes' series of 75% LR and 25% IR, this was 96%. Since TB delivers doses similar to HDR monotherapy, a conservative estimate of the success rate for TB is 97.5% for LR patients.
Time frame: 5 years
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