Randomized Trial Comparing Near Margin-Less Adaptive Radiation Therapy to Standard Stereotactic Ablative Radiotherapy in Men with Localized Prostate Cancer

What this Trial Is About

Researchers are evaluating quality of life differences in men with localized prostate cancer treated with two different radiation therapies. The study compares near margin-less adaptive radiation therapy ART, which adapts treatment based on information gathered during therapy and uses smaller margins to limit radiation to healthy tissue, against standard stereotactic ablative body radiotherapy SABR, a precise external radiation delivered over several days. The goal is to see if the shorter ART treatment can provide similar cancer control with fewer side effects impacting quality of life. Participants are randomly assigned to one of two groups one receives near margin-less ART in 2 treatments spaced at least 3 days apart, including imaging with cone beam CT and possibly CT or MRI scans the other receives standard SABR in 5 treatments spaced at least 2 days apart, with CT or MRI imaging. Treatments continue only if there is no disease progression or unacceptable side effects. After treatment, participants are followed with visits at 1, 3, and 6 months, then every 6 months for up to 5 years. Throughout the study, participants complete questionnaires assessing early and late changes in bowel and urinary quality of life, financial impact, erectile function, and prostate symptoms. Researchers also monitor physician-reported toxicities, biochemical markers of cancer progression, and survival. Imaging and dosimetry data are collected to explore treatment effects. This thorough monitoring aims to capture both patient experiences and clinical outcomes over up to 5 years.

Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer