Recruiting

HDR-BT vs. SABR

Sponsor:

Joelle Helou

Code:

NCT07300566

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard Arm: Whole Gland High Dose Rate Brachytherapy Boost

Experimental Arm: Focal High Dose Rate Brachytherapy Boost

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT07300566

Start date

Jun 10, 2026

Status verified date

Nov, 2025

Completion date

Mar, 2033

Anticipated

Primary completion date

Mar, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

58 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Whole Gland High Dose Rate Brachytherapy Boost Arm

experimental: Focal High Dose Rate Brachytherapy Boost Arm

Interventions

Standard Arm: Whole Gland High Dose Rate Brachytherapy Boost

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

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).

Primary outcome measure

  • Changes in Urinary Quality of Life at 24 Months Measured by the Expanded Prostate Index Composite (EPIC-26) Questionnaire [ Time Frame: From enrollment to 24 months post radiation therapy ]

Central Contacts and Locations

Central contacts

Joelle Helou, MD

519-685-8650Joelle.Helou@lhsc.on.ca

Locations

London Health Sciences Centre, Verspeeten Family Cancer Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Joelle Helou, MD

519-685-8650Joelle.Helou@lhsc.on.ca

Principal Investigator:

Joelle Helou, MD

More Information

Sponsor

Joelle Helou

Last update posted

Oct 5, 2026

Last verified

Nov, 2025

Keywords

  • Focal high dose rate brachytherapy
  • Whole gland high dose rate brachytherapy
  • External beam radiotherapy
  • Intermediate risk prostate cancer
  • High risk prostate cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by Joelle Helou on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.