Prostate CancerFORWARDNCT07300566
Focal Versus Whole Gland High Dose-Rate Brachytherapy (HDR-BT) Boost to External Beam Radiotherapy in Localized Prostate Cancer: A Phase 2 Randomized Trial
A study testing Standard Arm: Whole Gland High Dose Rate Brachytherapy Boost and Experimental Arm: Focal High Dose Rate Brachytherapy Boost in people with Prostate Cancer, run by Joelle Helou at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Standard Arm: Whole Gland High Dose Rate Brachytherapy Boost and Experimental Arm: Focal High Dose Rate Brachytherapy Boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jun 2026to Mar 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre, Verspeeten Family Cancer Centre
London, Ontario, N6A 5W9
Joelle Helou, MD, 519-685-8650, Joelle.Helou@lhsc.on.ca
Joelle Helou, MD
About this study
Official 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]
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
- Being tested
- Standard Arm: Whole Gland High Dose Rate Brachytherapy Boost, Experimental Arm: Focal High Dose Rate Brachytherapy Boost
- Keywords
- Focal high dose rate brachytherapy, Whole gland high dose rate brachytherapy, External beam radiotherapy, Intermediate risk prostate cancer, High risk prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Arm: Whole Gland High Dose Rate Brachytherapy BoostRadiation
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 BoostRadiation
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).
| Study group | Role | What they receive |
|---|---|---|
| Whole Gland High Dose Rate Brachytherapy Boost Arm | Active comparator | Not described Receives: Radiation: Standard Arm: Whole Gland High Dose Rate Brachytherapy Boost |
| Focal High Dose Rate Brachytherapy Boost Arm | Experimental | Not described Receives: Radiation: Experimental Arm: Focal High Dose Rate Brachytherapy Boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 24 months post radiation therapy
Secondary outcomes (6)
Acute Changes in Urinary, Bowel, and Sexual Quality of Life
Measured: 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
Changes in bowel and sexual health as reported by the participant on the Expanded Prostate Index Composite (EPIC-26) questionnaire.
Measured: 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
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.
Measured: From enrollment to 24 months post radiation therapy
Prostate Specific Antigen (PSA) at 4 years
Blood test measuring the amount of PSA protein made by the prostate.
Measured: 4 years post radiation therapy
Biochemical Control Measure by Prostate Specific Antigen (PSA) Levels
Measured: Enrollment to 5 years post radiation therapy
Participant reported Symptoms Measured by the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
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.
Measured: From enrollment to 24 months post radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start10 Jun 2026
- Primary completionMar 2031 (estimated)
- Study completionMar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joelle Helou
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre
- Responsible party
- Sponsor-investigator, Joelle Helou, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Joelle Helou, MD, Principal investigator, London Health Sciences Centre Research Institute, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300566
- Sponsor's protocol ID
- FORWARD - ReDA 16623
- Acronym
- FORWARD
- Status last verified
- Nov 2025
- First submitted
- 10 Dec 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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]
- ClinicalTrials.gov ID
- NCT07300566
- Acronym / sponsor ID
- FORWARD / FORWARD - ReDA 16623
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Joelle HelouUniversity, hospital or other
- Collaborators
- London Health Sciences Centre
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2033 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Arm: Whole Gland High Dose Rate Brachytherapy BoostWhole 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). | Radiation | Whole Gland High Dose Rate Brachytherapy Boost Arm |
| Experimental Arm: Focal High Dose Rate Brachytherapy BoostFocal 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). | Radiation | Focal High Dose Rate Brachytherapy Boost Arm |
Primary outcome
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.
6 secondary outcomes
Acute Changes in Urinary, Bowel, and Sexual Quality of Life
Time frame: 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
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
Prostate Specific Antigen (PSA) at 4 years
Time frame: 4 years post radiation therapy
Biochemical Control Measure by Prostate Specific Antigen (PSA) Levels
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joelle Helou, MD principal investigator
London Health Sciences Centre Research Institute, London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Arm: Whole Gland High Dose Rate Brachytherapy Boost and Experimental Arm: Focal High Dose Rate Brachytherapy Boost in people with Prostate Cancer, run by Joelle Helou at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joelle Helou, MD (519-685-8650, Joelle.Helou@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.