Clinical trial NCT06964412: The Use of Artificial Intelligence Generated Contours in Radiation Planning of the Prostate Brachytherapy
Official title: A Phase II Randomized Study of the Use of Artificial Intelligence Generated Contours in Ultrasound-based Prostate HDR Brachytherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinically approved contour vs. Manual and AI assisted contours
timeFrame: 1 day
Secondary outcomes:
measure: Contouring time
timeFrame: 1 day
measure: Impression of AI or manual contours by new learner
timeFrame: 1 day
measure: Impression of AI or manual contours by experienced clinician
timeFrame: 1 day
measure: Clinician contours vs. Trus images with and without needles
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Dana-Farber Cancer Institute / Brigham Women's Hospital
name: Martin King, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morton G, McGuffin M, Chung HT, Tseng CL, Helou J, Ravi A, Cheung P, Szumacher E, Liu S, Chu W, Zhang L, Mamedov A, Loblaw A. Prostate high dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: Efficacy results from a randomized phase II clinical trial of one fraction of 19 Gy or two fractions of 13.5 Gy. Radiother Oncol. 2020 May;146:90-96. doi: 10.1016/j.radonc.2020.02.009. Epub 2020 Mar 5.
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citation: Lavoie-Gagnon H, Martin AG, Poulin E, Archambault L, Pilote L, Foster W, Vigneault E, Carignan D, Lacroix F. Advantages of TRUS-based delineation for high-dose-rate prostate brachytherapy planning. J Contemp Brachytherapy. 2022 Feb;14(1):1-6. doi: 10.5114/jcb.2022.113544. Epub 2022 Feb 18.
citation: Podgorsak AR, Venkatesulu BP, Abuhamad M, Harkenrider MM, Solanki AA, Roeske JC, Kang H. Dosimetric and workflow impact of synthetic-MRI use in prostate high-dose-rate brachytherapy. Brachytherapy. 2023 Sep-Oct;22(5):686-696. doi: 10.1016/j.brachy.2023.05.005. Epub 2023 Jun 12.
citation: King MT, Kehayias CE, Chaunzwa T, Rosen DB, Mahal AR, Wallburn TD, Milligan MG, Dyer MA, Nguyen PL, Orio PF, Harris TC, Buzurovic I, Guthier CV. Observer preference of artificial intelligence-generated versus clinical prostate contours for ultrasound-based high dose rate brachytherapy. Med Phys. 2023 Oct;50(10):5935-5943. doi: 10.1002/mp.16716. Epub 2023 Sep 4.
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