NCT06964412

The Use of Artificial Intelligence Generated Contours in Radiation Planning of the Prostate Brachytherapy

A Phase II Randomized Study of the Use of Artificial Intelligence Generated Contours in Ultrasound-based Prostate HDR Brachytherapy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is investigating how AI can help doctors outline the prostate on an ultrasound image to make a custom radiation plan during a specialized type of radiation treatment for prostate cancer called brachytherapy.

Detailed description

This is a Phase II prospective study evaluating the standard U-net, a deep learning AI algorithm for auto-contouring of the prostate during HDR prostate brachytherapy with the needles in place by new learners. Contouring will be done on TRUS. The study will be conducted with a randomized design. Each patient will be assigned to a new learner and then randomized to manual versus AI-assisted contouring. The randomization will be stratified by new learner type: resident versus fellow/new attending. The hypothesis is that AI-assisted learner contours will have improved Dice coefficients with respect to clinically approved contours compared with manual learner contours. All brachytherapy contours will undergo review by the treating radiation oncologist who is the experienced clinician for clinical approval prior to patient treatment. The experienced clinician will be blinded to the randomization.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	Artificial-intelligence (AI)	Utilizing the addition of artificial intelligence during prostate contouring.

Timeline

• Start date: 2026-02-03
• Primary completion: 2026-04-15
• Completion: 2027-05-30
• First posted: 2025-05-09
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States