Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer in Patients With Lower Urinary Tract Symptoms and/or Prostate Hyperplasia (X-SMILE)

What this Trial Is About

This research aims to assess the safety, feasibility, and effectiveness of CT or MRI-guided online adaptive stereotactic body radiotherapy (SBRT) delivered in five weekly doses for patients newly diagnosed with localized prostate cancer who also have lower urinary tract symptoms or prostate hyperplasia. The study focuses on patients with intermediate to very high-risk localized prostate cancer meeting specific symptom and prostate volume criteria. It is an international, multicenter phase II study designed to evaluate treatment toxicity and continuation rates under carefully controlled conditions. Participants receive definitive SBRT to the prostate using either CT or MRI guidance, with treatment delivered once a week over five weeks. The prescribed doses target the prostate and seminal vesicles, adjusted based on the risk level and prostate volume, with allowances to reduce bowel exposure. The study includes a pilot phase and a validation cohort, each aiming to demonstrate low rates of severe acute and long-term urogenital toxicity and minimal treatment discontinuation. During the trial, participants will undergo assessments including toxicity monitoring up to five years after treatment, survival tracking, and quality-of-life evaluations using standard questionnaires. Optional uroflowmetry tests are performed before radiotherapy begins. The primary outcome focuses on acute severe urogenital toxicity within three months post-radiotherapy. Secondary outcomes include gastrointestinal toxicity, mortality, biochemical progression-free survival, hormonal therapy-free survival, overall survival, and patient quality of life over a five-year period.

Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer (X-SMILE)