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

December 10, 2025 updated by: Joelle Helou

FOcal Versus Whole Gland High Dose-Rate Brachytherapy (HDR-BT) Boost With ExternAl Beam Radiotherapy in LocalizeD Prostate Cancer: A Phase 2 Randomized Trial [FORWARD]

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre, Verspeeten Family Cancer Centre
        • Principal Investigator:
          • Joelle Helou, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Whole Gland High Dose Rate Brachytherapy Boost Arm
Radiation: 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: Focal High Dose Rate Brachytherapy Boost Arm
Radiation: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Changes in Urinary, Bowel, and Sexual Quality of Life
Time Frame: Less than or equal to 6 months post radiation therapy
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
Time Frame: From enrollment to 24 months post radiation therapy
Changes in bowel and sexual health as reported by the participant on the 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
Time Frame: From enrollment to 24 months post radiation therapy
Severity and grade of side effects of treatment as reported by the physician using the 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
Time Frame: 4 years post radiation therapy
Blood test measuring the amount of PSA protein made by the prostate.
4 years post radiation therapy
Biochemical Control Measure by Prostate Specific Antigen (PSA) Levels
Time Frame: Enrollment to 5 years post radiation therapy
Enrollment to 5 years post radiation therapy
Participant reported Symptoms Measured by the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time Frame: From enrollment to 24 months post radiation therapy
Frequency and severity of side effects of treatment as reported by the participant on the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire.
From enrollment to 24 months post radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joelle Helou

Collaborators

London Health Sciences Centre

Investigators

  • Principal Investigator: Joelle Helou, MD, London Health Sciences Centre Research Institute, London Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2033

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FORWARD - ReDA 16623

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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