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

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]

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Joelle Helou · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 have an identifiable DIL on mpMRI.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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).
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).

Timeline

• Start date: 2026-02-01
• Primary completion: 2031-03-01
• Completion: 2033-03-01
• First posted: 2025-12-24
• Last updated: 2025-12-24

Locations

1 site across 1 country: Canada