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Prostate CancerNCT06964412

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

A study testing Artificial-intelligence (AI) in people with Prostate Cancer, run by Brigham and Women's Hospital at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Artificial-intelligence (AI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
3 Feb 2026to 30 May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: A Phase II Randomized Study of the Use of Artificial Intelligence Generated Contours in Ultrasound-based Prostate HDR 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.

Read the 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
Being tested
Artificial-intelligence (AI)
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artificial-intelligence (AI)Other

    Utilizing the addition of artificial intelligence during prostate contouring.

Study groups in NCT06964412
Study groupRoleWhat they receive
MANUALLY GENERATED CONTOURS IN ULTRASOUND-BASED PROSTATE HDR BRACHYTHERAPNo interventionManual prostate contouring by a learner (resident or fellow/new attending) performing prostate HDR brachytherapy.
AI GENERATED CONTOURS IN ULTRASOUND-BASED PROSTATE HDR BRACHYTHERAPYExperimentalAI-assisted (U-net algorithm) prostate contouring by a learner (resident or fellow/new attending) performing prostate HDR brachytherapy.
Receives: Other: Artificial-intelligence (AI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 day

Secondary outcomes (4)

  1. Contouring time

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

    Measured: 1 day

  2. Impression of AI or manual contours by new learner

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

    Measured: 1 day

  3. Impression of AI or manual contours by experienced clinician

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

    Measured: 1 day

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

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

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2025
  2. Study start3 Feb 2026
  3. Primary completion30 May 2027 (estimated)
  4. Study completion30 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06964412
Sponsor's protocol ID
25-116
Status last verified
May 2026
First submitted
1 May 2025
Last updated
29 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32146259

  • 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.

    PubMed 31727300

  • 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.

    PubMed 23474112

  • 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.

    PubMed 33309278

  • 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.

    PubMed 35233228

  • 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.

    PubMed 37316376

  • 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.

    PubMed 37665729

  • 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.

    PubMed 24454995

Questions about this trial

What is this clinical trial studying?

A study testing Artificial-intelligence (AI) in people with Prostate Cancer, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinically approved contour vs. Manual and AI assisted contours (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06964412, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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