Focal Versus Whole Gland High Dose-Rate Brachytherapy (HDR-BT) Boost to External Beam Radiotherapy in Localized Prostate Cancer: A Phase 2 Randomized Trial
NCT ID: NCT07300566
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
58 participants
INTERVENTIONAL
2026-02-28
2033-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Whole Gland High Dose Rate Brachytherapy Boost Arm
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).
Focal High Dose Rate Brachytherapy Boost Arm
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).
Interventions
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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 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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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London Health Sciences Centre
OTHER
Joelle Helou
OTHER
Responsible Party
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Joelle Helou
Principal Investigator
Principal Investigators
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Joelle Helou, MD
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre Research Institute, London Health Sciences Centre
Locations
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London Health Sciences Centre, Verspeeten Family Cancer Centre
London, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Joelle Helou, MD
Role: primary
Other Identifiers
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FORWARD - ReDA 16623
Identifier Type: -
Identifier Source: org_study_id