The goal of this clinical trial is to learn if the use of MRI-guided asymmetric ultrahipofractionated irradiation (2 fractions with dose increase in the tumor areas and dose sparing in urethra, rectum and neurovascular bundles) produces similar results in terms of local control and complications to standard 5-fraction SBRT.
No prior radiation therapy to the target areas
Expected patient survival >5 years
Patient able to undergo a MRI exam
Suboptimal candidates for high-dose therapy such as elderly, frail patients or patients with large volume glands (i.e, >60cm3) or extensive TURP in the prior 6-12 months should be considered cautionary indications.
Prior radiation therapy to the target areas
Expected patient survival below 5 years
Patient unable to undergo a MRI exam
Sequential
MR-Guided SBRT
RadiationMR-Guided SBRT
Biochemical Relapse-Free Survival
To achieve a 4-year biochemical relapse-free survival of 95%.
Adverse Events
To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.
Quality of Life (QOL) assessment
Determination of QOL with International Prostate Symptom Score (IPSS) and European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-PR25. IPSS ranges from 0 to 35 with higher values representing worse functioning. EORTC QLQ PR-25 ranges from 0-100 with higher values representing better functioning.
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This trial is not recruiting at the moment. You can still explore other options:
