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

Sponsor: Joelle Helou • ClinicalTrials.gov ID: NCT07300566

Registry updated: 2026-10-05

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Description

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.

Interventions

Standard Arm: Whole Gland High Dose Rate Brachytherapy Boost (Radiation)
Whole gland high dose rate brachytherapy (15 Gray/1 fraction) plus stereotactic ablative radiotherapy to the prostate +/- pelvis (25 Gray/5 fractions). Androgen deprivation therapy 6 to 24 months (physician discretion).
Experimental Arm: Focal High Dose Rate Brachytherapy Boost (Radiation)
Focal high dose rate brachytherapy boost to the dominant intraprostatic lesion (15 Gray/1 fraction) plus stereotactic ablative radiotherapy to the prostate (30 Gray/5 fractions) +/- the pelvis (25 Gray/5 fractions). Androgen deprivation therapy 6 to 24 months (physician discretion).

Eligibility criteria

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

Conditions

Prostate Cancer

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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