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

NCT07300566 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: FORWARD - ReDA 16623
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Changes in Urinary Quality of Life at 24 Months Measured by the Expanded Prostate Index Composite (EPIC-26) Questionnaire

  To compare the impact on urinary quality of life (QoL) between focal high dose-rate brachytherapy (HDR-BT) boost and standard whole gland HDR-BT boost to stereotactic ablative radiotherapy (SABR) as reported by the participant on the Expanded Prostate Index Composite (EPIC-26) questionnaire.

  From enrollment to 24 months post radiation therapy

Secondary Outcomes (6)

• Acute Changes in Urinary, Bowel, and Sexual Quality of Life

  Less than or equal to 6 months post radiation therapy

• Long Term Changes in Bowel and Sexual Quality of Life Measured by Expanded Prostate Index Composite (EPIC-26) Questionnaire

  From enrollment to 24 months post radiation therapy

• Acute and Chronic Physician-Reported Toxicity Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

  From enrollment to 24 months post radiation therapy

• Prostate Specific Antigen (PSA) at 4 years

  4 years post radiation therapy

• Biochemical Control Measure by Prostate Specific Antigen (PSA) Levels

  Enrollment to 5 years post radiation therapy

Study Arms (2)

Whole Gland High Dose Rate Brachytherapy Boost Arm

ACTIVE COMPARATOR

Radiation: Standard Arm: Whole Gland High Dose Rate Brachytherapy Boost

Focal High Dose Rate Brachytherapy Boost Arm

EXPERIMENTAL

Radiation: Experimental Arm: Focal High Dose Rate Brachytherapy Boost

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).

Whole Gland High Dose Rate Brachytherapy Boost Arm

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).

Focal High Dose Rate Brachytherapy Boost Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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

Sponsors & Collaborators

• Joelle Helou: lead
• London Health Sciences Centre: collaborator

Study Sites (1)

London Health Sciences Centre, Verspeeten Family Cancer Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Joelle Helou, MD

  London Health Sciences Centre Research Institute, London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joelle Helou, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 24, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2033
• Last Updated: December 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)