NCT06964412

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
12mo left

Started Feb 2026

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Feb 2026May 2027

First Submitted

Initial submission to the registry

May 1, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 9, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

February 3, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Expected
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

May 1, 2025

Last Update Submit

March 17, 2026

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Clinically approved contour vs. Manual and AI assisted contours

    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.

    1 day

Secondary Outcomes (4)

  • Contouring time

    1 day

  • Impression of AI or manual contours by new learner

    1 day

  • Impression of AI or manual contours by experienced clinician

    1 day

  • Clinician contours vs. Trus images with and without needles

    1 day

Study Arms (2)

MANUALLY GENERATED CONTOURS IN ULTRASOUND-BASED PROSTATE HDR BRACHYTHERAP

NO INTERVENTION

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

AI GENERATED CONTOURS IN ULTRASOUND-BASED PROSTATE HDR BRACHYTHERAPY

EXPERIMENTAL

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

Other: Artificial-intelligence (AI)

Interventions

Artificial-intelligence (AI)OTHER

Utilizing the addition of artificial intelligence during prostate contouring.

AI GENERATED CONTOURS IN ULTRASOUND-BASED PROSTATE HDR BRACHYTHERAPY

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (8)

  • 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.

    PMID: 32146259BACKGROUND

  • Crook J, Marban M, Batchelar D. HDR Prostate Brachytherapy. Semin Radiat Oncol. 2020 Jan;30(1):49-60. doi: 10.1016/j.semradonc.2019.08.003.

    PMID: 31727300BACKGROUND

  • Chen CP, Weinberg V, Shinohara K, Roach M 3rd, Nash M, Gottschalk A, Chang AJ, Hsu IC. Salvage HDR brachytherapy for recurrent prostate cancer after previous definitive radiation therapy: 5-year outcomes. Int J Radiat Oncol Biol Phys. 2013 Jun 1;86(2):324-9. doi: 10.1016/j.ijrobp.2013.01.027. Epub 2013 Mar 6.

    PMID: 23474112BACKGROUND

  • Valle LF, Lehrer EJ, Markovic D, Elashoff D, Levin-Epstein R, Karnes RJ, Reiter RE, Rettig M, Calais J, Nickols NG, Dess RT, Spratt DE, Steinberg ML, Nguyen PL, Davis BJ, Zaorsky NG, Kishan AU. A Systematic Review and Meta-analysis of Local Salvage Therapies After Radiotherapy for Prostate Cancer (MASTER). Eur Urol. 2021 Sep;80(3):280-292. doi: 10.1016/j.eururo.2020.11.010. Epub 2020 Dec 11.

    PMID: 33309278BACKGROUND

  • 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.

    PMID: 35233228BACKGROUND

  • 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.

    PMID: 37316376BACKGROUND

  • 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.

    PMID: 37665729BACKGROUND

  • Sullivan GM, Artino AR Jr. Analyzing and interpreting data from likert-type scales. J Grad Med Educ. 2013 Dec;5(4):541-2. doi: 10.4300/JGME-5-4-18. No abstract available.

    PMID: 24454995BACKGROUND

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Artificial Intelligence

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AlgorithmsMathematical Concepts

Study Officials

  • Martin King, MD, PHD

    Dana-Farber Cancer Institute / Brigham Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation oncologist

Study Record Dates

First Submitted

May 1, 2025

First Posted

May 9, 2025

Study Start

February 3, 2026

Primary Completion

April 15, 2026

Study Completion (Estimated)

May 30, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations

US(1)