Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06964412

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age and older
  • Deemed suitable candidates for whole gland HDR prostate brachytherapy under general anesthesia as a monotherapy, boost or salvage treatment.

Exclusion criteria

  • Prior permanent seed LDR brachytherapy implant
  • Prior transurethral resection of the prostate (TURP)
  • Presence or insertion of a rectal spacer
  • Focal HDR brachytherapy treatment i.e. not whole prostate

Treatment and study plan

Artificial-intelligence (AI)

Other

Utilizing the addition of artificial intelligence during prostate contouring.

Primary outcomes

  1. Clinically approved contour vs. Manual and AI assisted contours

    Time frame: 1 day

    Dice coefficient [0: no match, 1: complete match] between the final clinically approved brachytherapy prostate contours versus the manual and AI-assisted contours provided by the new learner.

Secondary outcomes

  1. Contouring time

    Time frame: 1 day

    Contouring time-to-completion needed to generate and edit manual vs AI-assisted contours for a new learner.

  2. Impression of AI or manual contours by new learner

    Time frame: 1 day

    Subjective impressions/perception of AI or manual contours by the new learner based on survey responses.

  3. Impression of AI or manual contours by experienced clinician

    Time frame: 1 day

    Subjective impressions/perception of AI or manual contours by the experienced clinician based on survey responses.

  4. Clinician contours vs. Trus images with and without needles

    Time frame: 1 day

    Dice coefficients of expert clinician contours between TRUS images with implanted needles and TRUS images after removal of bottom needle rows.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 9, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.