Particle Therapy 2017

Clinical Trials Phase III

https://clinicaltrials.gov.it

Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer

(PCG)

àRandomized

àcT1a-T2a N0 M0, GS <6, PSA < 10

à5 fractions (7.6 Gy(RBE) x 5) VS 44 fractions (1.8 Gy(RBE) x 44)

àPrimary Outcome: to assess if hypo-fractionation will result in 2-year freedom from failure (FFF) that is non-

inferior to 2-year FFF following standard fractionation Secondary Outcome: To evaluate toxicity (GU/GI) and QoL

àSecondary outcome: grade 2 or greater GU and GI toxicity in each of the regimens.

Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk

Prostate Cancer.

(Proton Collaborative Group)

àRandomized

àGS 7, PSA > = 10 and < = 20, T stage T2b - T2c N0 M0

àTotal Dose=70 Gy(RBE) OR High Dose Radiation with IMRT Alone=81 Gy OR Intraoperative LDR

Brachytherapy and IMRT=45 Gy +/- ADT

àPrimary Outcome: freedom from failure (FFF) (clinical or biochemical failure)

àSecondary outcome: Frequency and severity of GI and GU toxicity, QoL

Protontherapy vs. IMRT for Low or Intermediate Risk Prostate Cancer (PARTIQoL)

(MGH)

Randomized

àcT1c-T2c, GS < 7, PSA < 20

àPBT vs. IMRT once a day for 5 days (no weekends or holidays) for up to 9 weeks

àPrimary Outcome: Efficacy of PBT vs. IMRT

àSecondary outcome: QoL, Cost Effectiveness of PBT vs. IMRT, Radiation Dose and Bowel, Urinary and Erectile

Function, Identification and Evaluation Biomarkers of PCa Behavior, Long Term Survival.