Prostate Stereotactic ablative body radiotherapy (SABR) is an established technique that delivers radiation in a non-invasive approach for men with prostate cancer. The treatment regimen is given in total of 5 fractions with one treatment per day at every other day or weekly sessions. Ultra-hypofractionated radiotherapy (UHRT) is an emerging monotherapy for localized prostate cancer however, several trials have observed demonstrating superior biochemical control of a two-fraction (HDR) over single-fraction approach. The study aims to compare an experimental shorter course of prostate ultra-hypofractionated radiotherapy (UHRT) that will deliver what is expected to be an equivalent amount of radiation as given in the standard 5 treatment regimen. UHRT is given in 2 treatments with one treatment a week for 2 consecutive weeks.
Histologically confirmed prostate adenocarcinoma (centrally reviewed)
Low risk - T1-T2b, grade group 1, AND PSA < 10 ng/ml;
Favorable risk
Only one of the following intermediate risk factors - cT2c, grade group 2, or PSA 10-20 ng/ml; or
Androgen deprivation therapy (LHRH-agonists or antiandrogens) given or planned
Prior pelvic radiotherapy
Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
Diagnosis of bleeding diathesis
Parallel
Stereotactic Ablative Body Radiation
Radiation2 Fraction
Prostate Cancer Patient's Quality of Life Function will be measured to determine change in Quality of life function from baseline to 5 years beyond treatment.
Expanded Prostate Cancer Index Composite questionnaires will be scored and analyzed to determine change in Quality of life function from baseline
Toxicity in patients
Incidence of acute Gastrointestinal (GI) and Genitourinary (GU) complications using CTCAE v4
Proportion of patients with 4 year PSA value of <0.4 ng/ml
Proportion of patients with 4 year PSA value of \<0.4 ng/ml
Biochemical Control in Prostate Patients
5 year biochemical failure rates using Phoenix definition (as nadir PSA +2ng/mL)
Salvage Therapy Rate
Analysis of prostate patients requiring salvage treatment using Androgen Deprivation Therapy, surgery or brachytherapy
Click on the lead sponsor to view all of their trials.
Sunnybrook Health Sciences Centre
Lead sponsor
Prostate Cure Foundation
Collaborator
