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.
- histologically proven prostate adenocarcinoma within 1 year of enrollment
- Low risk: Gleason <or=6 & PSA <or=10 & Clinical Stage T1b-T2a,Nx or N0, Mx or M0
- Intermediate risk:Gleason <or=6 & PSA<or=10 & Clinical Stage T2b OR Gleason=7 &
PSA<or=10 & Clinical Stage T1b-T2b OR Gleason <or=6 & PSA > 10 & < or =20 & Clinical
Stage T1b- T2b, Nx or NO, Mx or M0
- ECOG Performance Status 0-1
- No prior prostate radiation or other definitive therapy
- implanted hardware or other material that would prohibit treatment planning or
- chemotherapy for a malignancy within the previous 5 years
- history of an invasive malignancy (other than this prostate cancer,or basal or
squamous skin cancers) within prior 5 years
- hormone ablation for 2 months prior to treatment or during treatment