Focal Versus Whole Gland High Dose-Rate Brachytherapy (HDR-BT) Boost to External Beam Radiotherapy in Localized Prostate Cancer: A Phase 2 Randomized Trial

What this study is about

This project aims to compare the changes in the urinary quality of life (QoL) following focal high dose-rate brachytherapy (HDR-BT) boost to stereotactic ablative radiotherapy (SABR), compared to standard whole gland HDR-BT boost, in the treatment of men diagnosed with intermediate- and high-risk prostate cancer, with have an identifiable DIL on mpMRI.

Who can join (things the study team will check)

✅ You may be able to join if…

• Histologically confirmed diagnosis of adenocarcinoma of the prostate
• Eastern Co-Operative Oncology Group (ECOG) 0-2
• Intermediate and high-risk disease with localized unfavorable features:
  • defined as clinical stage tumor cT1 or cT2a, International Society of Urological Pathology (ISUP) grade group 2-4 in less than or equal to 50% of the cores, unilateral extracapsular extension (ECE), prostate specific antigen (PSA) less than or equal to 20 ng/mL
  • corresponding to an Identified dominant intraprostatic lesion (DIL) on multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging Reporting and Data System score (PI-RADs 3-5)
• Prostate volume less than or equal to 60 cc is recommended. Transrectal ultrasound (TRUS) and magnetic resonance imaging (MRI) are accepted to assess prostate volume. Patients with a prostate volume between 60 and 80 cc can be included if the International Prostate Symptom Score (IPSS) is less than 15 and brachytherapy is deemed feasible by the treating physician.

🚫 You may not be able to join if…

• Contraindications to mpMRI
• Documented nodal or distant metastases
• Previous pelvic radiotherapy
• Recent transurethral resection of prostate (less than or equal to 6 months), previous prostatectomy or high-intensity focused ultrasound (HIFU)
• Poor baseline urinary function: International Prostate Symptom Score (IPSS) greater than 19
• Connective tissue disease or inflammatory bowel disease
• Patients deemed unsuitable for general anaesthetic by the Anaesthesia Department
• Patient is unable to lie flat long enough for the Radiation Therapy (RT) Simulation and Treatment

Where this trial is running

• London Health Sciences Centre, Verspeeten Family Cancer Centre, London, Ontario, Canada

Who to contact

Joelle Helou, MD · 519-685-8650 · Joelle.Helou@lhsc.on.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07300566.