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

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2027-05-30

Brief Summary

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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.

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Detailed Description

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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

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

The experienced clinician will be blinded to the randomization of the contouring method by the new learner. The prostate contour generated by the new learner will then undergo review by the experienced clinician.

Study Groups

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MANUALLY GENERATED CONTOURS IN ULTRASOUND-BASED PROSTATE HDR BRACHYTHERAP

Manual prostate contouring by a learner (resident or fellow/new attending) performing prostate HDR brachytherapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

AI GENERATED CONTOURS IN ULTRASOUND-BASED PROSTATE HDR BRACHYTHERAPY

AI-assisted (U-net algorithm) prostate contouring by a learner (resident or fellow/new attending) performing prostate HDR brachytherapy.

Group Type EXPERIMENTAL

Artificial-intelligence (AI)

Intervention Type OTHER

Utilizing the addition of artificial intelligence during prostate contouring.

Interventions

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Artificial-intelligence (AI)

Utilizing the addition of artificial intelligence during prostate contouring.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No