Improving Sexual Quality of Life - Randomized Trial of Two vs Five MRI Guided SABR Treatments for Prostate Cancer

What this study is about

Prostate Stereotactic ablative body radiotherapy (SABR) is an established technique that delivers radiation in a non-invasive approach for men with prostate cancer. The treatment regimen is given in total of 5 fractions with one treatment per day at every other day or weekly sessions. Ultra-hypofractionated radiotherapy (UHRT) is an emerging monotherapy for localized prostate cancer however, several trials have observed demonstrating superior biochemical control of a two-fraction (HDR) over single-fraction approach. The study aims to compare an experimental shorter course of prostate ultra-hypofractionated radiotherapy (UHRT) that will deliver what is expected to be an equivalent amount of radiation as given in the standard 5 treatment regimen. UHRT is given in 2 treatments with one treatment a week for 2 consecutive weeks.

Who can join (things the study team will check)

✅ You may be able to join if…

• Histologically confirmed prostate adenocarcinoma (centrally reviewed)
• Low or favorable intermediate risk disease. Patient must meet one of the following categories:
  • Low risk - T1-T2b, grade group 1, AND PSA < 10 ng/ml;
  • Favorable risk
  • Only one of the following intermediate risk factors - cT2c, grade group 2, or PSA 10-20 ng/ml; or
  • Grade group 3 AND PSA < 20, AND <cT2c AND absolute percentage pattern 4/5 is <10%

🚫 You may not be able to join if…

• Androgen deprivation therapy (LHRH-agonists or antiandrogens) given or planned
• Prior pelvic radiotherapy
• Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
• Diagnosis of bleeding diathesis
• Large prostate (>90cm3) on imaging
• Immunosuppressive medications
• Inflammatory bowel disease
• Presence of dual hip prostheses
• Contraindications to having MRI

Where this trial is running

• Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Who to contact

Danny Vesprini, MD · 416-480-6100 · Danny.Vesprini@sunnybrook.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05600400.