Focal HDR-BT Boost vs Whole-Gland HDR-BT Boost for Localized Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 randomized trial compares two HDR brachytherapy boost strategies added to external beam radiotherapy for men with intermediate- or high-risk localized prostate cancer who have a dominant intraprostatic lesion visible on mpMRI. Participants are assigned to receive either a focal HDR-BT boost to the lesion or a standard whole-gland HDR-BT boost, in addition to EBRT. The study focuses on urinary quality of life changes after treatment, with analysis targeting changes from baseline in this domain. Eligibility includes histologically confirmed prostate adenocarcinoma, ECOG 0-2, and mpMRI-identified DIL within defined risk and anatomic criteria. Prostate volume thresholds and IPSS criteria may permit inclusion for some larger glands.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 it's running

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

Study contacts

• Principal investigator: Joelle Helou, MD — London Health Sciences Centre Research Institute, London Health Sciences Centre
• Study coordinator: Joelle Helou, MD
• Email: Joelle.Helou@lhsc.on.ca
• Phone: 519-685-8650

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.