This study is being proposed to evaluate the use of moderate hypofractionated proton therapy in low and intermediate risk prostate cancer patients. Quality of life outcomes as well as gastrointestinal and genitourinary early and late toxicities will be analyzed and compared to conventional proton therapy regimens. It is thought that this regimen will produce comparable findings and would result in substantial health care cost savings, as well as, be more convenient for patients.
Patients will receive: 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
235
Provision Cares Proton Therapy Center Knoxville
Knoxville, Tennessee, United States
RECRUITINGProvision Cares Proton Therapy Center Nashville
Nashville, Tennessee, United States
RECRUITINGTime to biochemical failure
To determine the freedom from biochemical failure survival outcomes (FFBF) and compare to historical FFBF results achieved following standard fractionation proton therapy
Time frame: 5 years
Toxicity Assessment
To determine the incidence of acute and late Gastrointestinal and Genitourinary toxicity at 2 and 5 years.
Time frame: 2 years & 5 years
Analyze Quality of Life
To assess quality of life following proton therapy (QOL EPIC) at 2 and 5 years
Time frame: 2 years & 5 years
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