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Prostate CancerNCT04441775

Artificial Intelligence for Prostate Cancer Treatment Planning

An observational study of Prostate Cancer and Artificial Intelligence, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project's goal is to develop and test an application that uses Artificial Intelligence (AI) to improve consistency and quality of Radiation Treatment (RT) plans for prostate cancer. Read more about this study

Who is it for?
Ages 21 to 90 years, men only
What is being tested?
AI-assisted RT modelling
How many people
5 participants
Where
1 siteUnited States
Study dates
22 Jun 2020to 4 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

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 21 to 90 years
  • Men only
  • Adult, Older adult

Study population: Male patients diagnosed with prostate xancer who have received RT and now have elected to provide data for the development of AI-models.

Who may be able to join

  • Favorable-risk inclusion criteria (as per RTOG 0415)
  • Histologically confirmed prostate adenocarcinoma
  • Gleason Score <= 3+4 = 7 ( with less than 50% of all cores positive, and no more than one core with Gleason 3+4=7)
  • Clinical stage T1-T2b
  • Prostate Specific Antigen (PSA) <10 ng/ml within 180 days prior to treatment planning. PSA may not have been acquired within 30 days of stopping finasteride, or within 90 days of stopping dutasteride
  • RT treatment initiated between 1/1/15 and 12/31/16
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  • Prostate MRI used as part of RT treatment planning
  • No previous hormonal therapy, such as LHRH agonists, estrogens, anti-androgens, or surgical castration
  • No previous use of finasteride within 30 days prior to planning
  • No previous use of dutasteride within 90 days prior to planning
  • High-risk inclusion criteria (as per RTOG 0521)
  • Histologically confirmed prostate adenocarcinoma
  • PSA < 150
  • One of the following combinations:
  • Gleason 7 or 8 and PSA >= 20
  • Gleason 8 and clinical T-stage > T2a
  • Gleason 9 or 10
  • Negative bone scan within 180 days of planning
  • XRT treatment initiated between 1/1/15 and 12/31/16
  • Prostate MRI used as part of RT treatment planning
  • No previous hormonal therapy, such as LHRH agonists, estrogens, anti-androgens, or surgical castration, prior to prostate cancer diagnosis
  • Intermediate-risk inclusion criteria
  • Histologically confirmed prostate adenocarcinoma
  • PSA < 20
  • Gleason 7 or 8
  • Not meeting criteria for favorable- or high-risk disease, as per above
  • XRT treatment initiated between 1/1/15 and 12/31/16
  • Prostate MRI used as part of RT treatment planning
  • No previous hormonal therapy, such as LHRH agonists, estrogens, anti-androgens, or surgical castration, prior to prostate cancer diagnosis

Who cannot join

  • Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years
  • Evidence of distant metastases
  • Regional lymph node involvement
  • Previous radical prostate surgery or cryosurgery
  • Previous pelvic irradiation or prostate brachytherapy
  • Previous or concurrent cytotoxic chemotherapy for prostate cancer
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  • Severe, active comorbidity, defined as follows:
  • Unstable angina, congestive heart failure, and/or transmural myocardial infarction requiring hospitalization within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics
  • Hepatic insufficiency resulting in clinical jaundice or coagulopathy
  • Acquired immune deficiency syndrome based upon current CDC-defined criteria
  • Zubrod performance status 2 or worse
  • Previous use of finasteride within 60 days of planning
  • Previous use of dutasteride within 180 days of planning

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

Other trials in United States

About this study

Official title: Protocol for the Development of a Machine Learning Model for Prostate Cancer Treatment Planning

This project's goal is to develop and test an application that uses Artificial Intelligence (AI) to improve consistency and quality of Radiation Treatment (RT) plans for prostate cancer. By understanding expert planner preferences in structure contouring and treatment planning, and combining this framework with planning data and outcomes amassed in NRG clinical trials, AI models may be trained to produce contours and treatment plans that are indistinguishable or even potentially deemed superior to those produced by individual experts.

At the conclusion of this contract, the awardees will provide a software product which, when given the input of a description of desired anatomical target volumes and target doses along with a patient's CT scans, will generate target volumes and radiation treatment plans based upon a "gold standard" amalgamated from the input of multiple experts, thereby achieving desired doses to target volumes while meeting or exceeding the dose-volume constraints imposed by adjacent normal tissues.

Read the detailed description

PHASE 1

  1. Develop a process and tools (DAST) to capture the rationale, criteria, and logical basis behind the treatment planning process using well understood Human Factors knowledge gathering methodologies and Machine Learning tools.
  2. Build the AI technology to learn the process and apply it to generating treatment plans. Images and expert-drawn volumes from Radiation Therapy Oncology Group (RTOG) 0938 will be used for initial training of the AI system. These data are not Dartmouth-Hitchcock Medical Center (DHMC) patients, but rather were consented and acquired through RTOG 0938. These data are housed at NRG/RTOG headquarters in Philadelphia. NRG already has an established, IRB-approved protocol for exploring AI systems for the 0938 data set. A minimum of 30 cases will be used for this initial training work for the AI system to "learn" volume segmentation of important structures and targets. Additional patients from the available 200+ patients on 0938 may be added for additional AI learning of volume segmentation as initial software programming is implemented.
  3. Determine the optimal number of historic treatment plans to train the AI technology and test it. 45 cases will be provided by NRG from NRG/RTOG studies 0415, 0126, and 0521 (totaling 135 cases), respectively representing favorable-, intermediate-, and high-risk prostate cancer treatments. These scans and expert-defined volumes are part of NRG datasets housed in Philadelphia. All these patients already signed study-specific consents which included permissions to allow personally specific clinical information to be used for other cancer-related studies. IRB review of the use of these data for this specific study is anticipated to be achieved through NRG mechanisms in the context of these prior consents, to assure that the use of these data for this specific AI study is appropriate and approved. Provision is anticipated of a total of 30 additional patient cases as "gold standards," 10 each from DHMC, University of Massachusetts (UMass), and Oregon Health Sciences University (OHSU), respectively, all initially planned and treated within the 2015-2018 time frame. The first 5 from each institution will be favorable-risk patients, and the next 5 from each institution will be high-risk patients (thereby achieving a wide range of treatment approaches, with more to be added subsequently). As part of this effort, each individual institution will contact its own specific patients (5 favorable-risk, 5 high-risk) to obtain study-specific consent for the use of their data for this protocol. Once anonymized, these scans and plans will be shared across all three institutions. For each of these patients, the other two ("non-host") institutions will create their own volumes and plans. Using a modified Delphi approach, the three teams will then meet to generate an agreed-upon "composite" plan for each patient. Thus, in total there will be four treatment plans for each of these 30 patients, yielding 120 total plans that will serve as the "gold standard" for this AI project, and will be inputted for testing/validation to the AI system. PHASE 2
  4. Expand the database to include intermediate-risk patients, 5 respectively from each institution, following the above procedures, to yield an additional 60 plans to serve as additional inputs for the AI system.
  5. Validate and test the AI technology by inputting patient images and target delineations from historic case data and assessing whether the AI technology-generated plans are "consistent" with the final plans that were created by expert clinicians.
  6. Test the technology with new patient case data and validate the plan with a team of expert clinicians. This will involve "modified Turing tests," as developed in NRG-RTOG studies exploring AI applications.
Being tested
AI-assisted RT modelling
Keywords
Prostate Cancer, Artificial Intelligence, Radiation Therapy, Radiation Planning
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • AI-assisted RT modellingOther

    Artificial Intelligence assisted Radiation Treatment

Study groups in NCT04441775
Study groupRoleWhat they receive
All patients for enrollment and analysisPatients previously treated with RT for prostate cancer who are now being enrolled into this study for data analysis and incorporation into Artificial Intelligence (AI) models
Receives: Other: AI-assisted RT modelling

What is being measured

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

  1. Change (trend) in AI System performance over time

    Validate the AI technology by inputting images and targets from historic case data and then assessing whether the AI-generated plans are comparable or even improved when measured against plans created by expert clinicians for the same patient data. To accomplish this, methodology will employ "modified Turing tests," as previously developed in NRG-RTOG studies exploring AI applications in other venues, whereby blinded experts evaluate alternative plans, score them on a variety of criteria, and more generally assess whether these were generated via machine learning or via human intelligence.

    These quantified comparisons will be performed several times. The first will be at the end of Phase I (spring of 2021). Phase II will introduce further data and plans. Repeat comparisons of AI- versus human-performance will be performed every six months during Phase II. Final comparisons and overall trend analysis will be reported at conclusion of Phase II in 2023.

    Measured: Baseline measure (Phase 1): June 2021. Repeat assessments every 6 months (Phase 2): June 2021 - June 2023.

Timeline

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

  1. First posted22 Jun 2020
  2. Study start22 Jun 2020
  3. Primary completion30 Nov 2021
  4. Study completion4 Mar 2022

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04441775
Sponsor's protocol ID
D20003
Other IDs
75N91019C00054-0-9999-1
Status last verified
Oct 2023
First submitted
6 Jun 2020
Last updated
13 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There are no plans to share individual participant data at this time.

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer and Artificial Intelligence, run by Dartmouth-Hitchcock Medical Center 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 29 inclusion and 14 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: finished, as of the sponsor's last update on 13 Oct 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change (trend) in AI System performance over time (time frame: Baseline measure (Phase 1): June 2021. Repeat assessments every 6 months (Phase 2): June 2021 - June 2023.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 13 Oct 2023.

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