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NCT Number: NCT07300566

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

London Health Sciences Centre, Verspeeten Family Cancer Centre

London, Ontario, N6A 5W9, Canada

Location contact

Joelle Helou, MD

CONTACT

[email protected]

519-685-8650

Joelle Helou, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Acute Changes in Urinary, Bowel, and Sexual Quality of Life

    Time frame: Less than or equal to 6 months post radiation therapy

  2. 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.

  3. 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.

  4. 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.

  5. Biochemical Control Measure by Prostate Specific Antigen (PSA) Levels

    Time frame: Enrollment to 5 years post radiation therapy

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Joelle Helou, MD

CONTACT

[email protected]

519-685-8650

Sponsors and collaborators

Lead sponsor

Joelle Helou

Other

Collaborators

  • London Health Sciences Centre

Registry information

Official study title

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]

Acronym: FORWARD

Important dates

Study start
2026
Primary completion
2031
Study completion
2033
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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