Study of MRI- or CT-Guided Stereotactic Body Radiation Therapy with and without Daily Plan Adaptation for Localized Prostate Cancer

What this Trial Is About

Researchers are evaluating the side effects and benefits of image-guided stereotactic body radiation therapy SBRT with and without daily online plan adaptation for treating patients with localized prostate adenocarcinoma, a type of prostate cancer that has not spread to other parts of the body. Image-guided SBRT uses imaging techniques like CT or MRI to direct radiation to the tumor area. This study aims to find out if adapting the radiation plan daily based on the patients current anatomy can reduce side effects compared to conventional SBRT that uses a fixed plan. Participants are randomly assigned to one of two groups. One group receives MRI or CT-guided SBRT without daily plan changes, receiving a total of 5 treatments over 18 days. The other group receives MRI or CT-guided SBRT with daily plan adaptation, also consisting of 5 treatments over 18 days. During the study, all participants undergo MRI and CT scans during screening, and blood samples are collected throughout the trial. Follow-up visits are scheduled up to five years after the treatment period. During the study, participants will complete questionnaires that assess urinary symptoms, sexual health, and quality of life. Researchers will also evaluate physician-scored side effects related to urinary and gastrointestinal health. The main outcome is the change in urinary symptoms reported by patients within 90 days after radiation therapy. Long-term monitoring includes quality of life and side effects assessments up to 60 months. The study also examines biochemical recurrence-free survival over five years, with safety and side effects tracked throughout the follow-up period.

Image-Guidance and Online Adaptation With Stereotactic Body Radiation Therapy for the Treatment of Localized Prostate Cancer, MANTICORE Trial