NCT07300566Recruiting
Focal Versus Whole Gland High Dose-Rate Brachytherapy (HDR-BT) Boost to External Beam Radiotherapy in Localized Prostate Cancer: A Phase 2 Randomized Trial
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]
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- First submitted
- 10 Dec 2025
- Start date
- 10 Jun 2026
- Primary completion date
- Mar 2031
- Lead sponsor
- Joelle Helou
- Diseases
- Prostate cancer
- NCT number
- NCT07300566
What you commit to
- Study type: Interventional
- Planned participants: 58
- From 10 Jun 2026 to the primary completion date, Mar 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic radiotherapy
- Recent transurethral resection of prostate (less than or equal to 6 months), previous prostatectomy or high-intensity focused ultrasound (HIFU)
- Patient is unable to lie flat long enough for the Radiation Therapy (RT) Simulation and Treatment
Other illness
- Connective tissue disease or inflammatory bowel disease
Other
- Contraindications to mpMRI
- Documented nodal or distant metastases
- Poor baseline urinary function: International Prostate Symptom Score (IPSS) greater than 19
- Patients deemed unsuitable for general anaesthetic by the Anaesthesia Department
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Health Sciences Centre - Verspeeten Family Cancer Centre Coordinator of this site? Confirm its status | London | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.