A Feasibility Trial of Proton Radiation Therapy Using Standard Fractionation for Low-Risk Adenocarcinoma of the Prostate
I. Feasibility of proton radiation therapy (RT) using standard fractionation.
I. To determine freedom from failure (FFF) (vs. biochemical/clinical progression-free
survival) with standard fractionation.
II. To determine the incidence of grade 2 or greater GU and GI toxicity with this regimen at
6 months, 2 years and 3 years.
III. To assess quality of life issues following completion of radiation therapy at 6 months
and at 2 years.
IV. To assess incidence of impotence after the use of proton therapy at 3 years.
V. To determine freedom from biochemical failure (BF) at 5 years.
VI. To determine clinical failure: local and/or distant at 5 years. VII. To determine
salvage androgen deprivation (SAD) use at 5 years. VIII. To determine progression free
survival: using clinical, biochemical and SAD as events at 5 years.
IX. To determine overall survival at 5 years. X. To determine disease-specific survival at 5
XI. Estimate prostate and normal structures movement during RT with the use of scans.
XII. Correlate pathologic and radiologic findings with outcomes at 5 years. XIII. Correlate
PSA and free PSA levels with outcomes at 5 years. XIV. Correlate testosterone levels and
variation with proton therapy and outcomes at 5 years.
XV. Develop a quality assurance process for proton prostate therapy.
Patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3 months, every 6 months for 5
years, and then annually thereafter.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility
United States: Institutional Review Board
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|