Comparing Moderate External Beam Radiotherapy with Ultra Hypofractionation and Brachytherapy for Treating Low Volume Oligometastatic Prostate Cancer in Men

What this Trial Is About

Researchers are evaluating different radiation treatments for men newly diagnosed with low volume oligometastatic prostate cancer, defined as fewer than five bone metastases andor non-regional lymph node involvement. The study aims to compare ultrahypofractionation using stereotactic ablative radiotherapy SABR or brachytherapy with moderately hypofractionated external beam radiotherapy EBRT to see if they are similarly well-tolerated. Secondary goals include assessing progression-free survival, overall survival, and cost-effectiveness. The trial hypothesizes that ultrahypofractionation will provide favorable toxicity profiles and quality of life while maintaining similar or better effectiveness, offering a convenient and cost-effective alternative to standard EBRT. Participants will be randomly assigned to one of four treatment groups standard EBRT delivering 5500 centiGray in 20 fractions over 4 weeks a single outpatient fraction of 19 Gray high dose rate brachytherapy under anesthesia a single outpatient permanent implant of radioactive Iodine-125 seeds delivering 125 Gy under anesthesia or SABR delivering 36.25 Gy in 5 fractions either weekly or every second day. Each treatment center selects its preferred brachytherapy or SABR option to balance enrollment across the four groups. During the study, urinary symptoms will be closely monitored over two years using the International Prostate Symptom Score IPSS at six time points. Additional assessments include quality of life questionnaires focusing on urinary, bowel, and sexual health, as well as biochemical markers, progression monitoring, survival, and cost-effectiveness over up to three years. Participants will complete these evaluations while receiving long-term androgen deprivation therapy and follow-up care to track treatment impact and safety.

5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)