Phase II Study of MR-linac Guided Stereotactic Ablative Radiotherapy for Localized and Oligometastatic Prostate Cancer

What this Trial Is About

Researchers are evaluating the tolerability and effects of MR-linac based stereotactic ablative radiotherapy MRL-SBRT in patients with localized prostate cancer, including those with oligo-metastatic disease. The study aims to assess acute and late toxicities, treatment efficacy, quality of life, feasibility of dose planning with simultaneous-boosts for MRI-detected tumor areas, and the relationship between blood and tissue biomarkers with imaging changes before and after treatment. Participants receive ultra-hypofractionated radiotherapy using a 1.5-Tesla MR-linac device targeting the prostate without adjacent oligo-metastatic diseases. The treatment is delivered in a specialized manner guided by magnetic resonance imaging to focus on the tumor area. The study includes different risk groups of prostate cancer and allows treatment of all metastatic foci with radical SBRT dose where applicable. During the study, participants are monitored for treatment-related acute and late toxicities using standard criteria up to five years. Quality of life is evaluated regularly from treatment start through several years post-therapy. Researchers also measure biochemical relapse-free survival at two years. Assessments include imaging, biomarker analysis, and patient-reported outcomes. The total participation time includes frequent follow-ups to carefully observe treatment effects and safety.

MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer (SMART-P01 and SMART-P02)