Particle Therapy 2017

926-927 / 2605

Clinical Trials Phase II: Hypofractionation
PI Type of study Inclusion criteria Treatment Primary outcome
Provision Center for
Proton Therapy
NCT02040610
Non randomized,
single arm
cT1-2c N0 M0,
GS <7, PSA < 20
62 Gy (RBE) in 20 fracKons of 3.1 Gy
(RBE) over 4 weeks
Time to biochemical
failure
MD Anderson
NCT01950351
Non randomized,
Single arm.
cT1-2b, GS <7,
PSA < 20
55.5 Gy (RBE) delivered in 15 fracKons
of 3.7 Gy (RBE)
Incidence of G2
GastrointesKnal Toxicity
NaKonal Cancer
Center, Korea
NCT01709253
Randomized,
4 arms
cT1-2c N0 M0 60CGE/20fx/5wks (4wk) VS
54CGE/15fx/5wks (3/wk) VS
47CGE/10fx/5wk (2/wk) VS 35CGE/
5fx/2.5wk(2/wk)
Biochemical failure-free
survival (BCFFS)
Loma Linda University
NCT00831623
Non randomized
Single Group
Assignment
cT1-2c, PSA < 10 3CGE/day, 5 days/week for 20
treatments (=60 CGE to isocenter/20
fracKons).
Treatment-related late
morbidity
University of Florida
NCT01368055
Non randomized,
Parallel
Assignment
GS < 7; PSA < 20 Low Risk 70 Gy/CGE VS Intermediate
risk 72.5 Gy/CGE 5-6 weeks
Incidence of treatment-
related grade 2 or higher
rectal bleeding.
Abramson Cancer
Center of the
University of
Pennsylvania
NCT01352429
ObservaKonal
Model: Cohort,
ProspecKve
cT1a-T2c N0 M0,
GS < 7; PSA < 20
Register the treatment data of
intermediate risk PCA for definiKve
radiaKon treatment with either proton
radiotherapy or Intensity Modulated
RadiaKon Therapy (IMRT)
Acute toxicity