Phase III Trial of Neutron + Photon Radiation Versus Photon + Hypofractionated Intensity Modulated Radiation Therapy in Localized Prostate Cancer
- Compare the efficacy of neutron and photon radiotherapy vs hypofractionated intensity
modulated radiation, in terms of a lower frequency of chronic complication rate
(chronic toxicity and disease-free survival), in patients with favorable to
intermediate prognosis, stage I-III adenocarcinoma of the prostate.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage
of disease (T1 vs T2 vs T3). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo neutron radiotherapy over 15-45 minutes 5 days a week for 2
weeks followed by photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks.
- Arm II: Patients undergo photon radiotherapy over 15-45 minutes 5 days a week for 5
weeks followed by hypofractionated photon irradiation over 15-45 minutes 5 days a week
for 2 weeks.
After completion of study treatment, patients are followed periodically for 5 years and then
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this
Allocation: Randomized, Primary Purpose: Treatment
Occurrence of chronic grade 2 or higher toxicity as measured by RTOG/EORTC late morbidity scoring scheme at 1, 4, 8, and 12 months after treatment, then every 6 months for 5 years, then annually
Jeffrey D. Forman, MD, FACR
Weisberg Cancer Treatment Center
United States: Federal Government