Clinical trial · Observational
Artificial Intelligence for Prostate Cancer Treatment Planning
Protocol for the Development of a Machine Learning Model for Prostate Cancer Treatment Planning
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Artificial Intelligence | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI-assisted RT modelling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- All patients for enrollment and analysis
- description
- Patients 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
- interventionNames
- Other: AI-assisted RT modelling
Primary outcomes (1)
- measure
- Change (trend) in AI System performance over time
- timeFrame
- Baseline measure (Phase 1): June 2021. Repeat assessments every 6 months (Phase 2): June 2021 - June 2023.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria:
* Favorable-risk inclusion criteria (as per RTOG 0415)
1. Histologically confirmed prostate adenocarcinoma
2. Gleason Score \<= 3+4 = 7 ( with less than 50% of all cores positive, and no more than one core with Gleason 3+4=7)
3. Clinical stage T1-T2b
4. 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
5. RT treatment initiated between 1/1/15 and 12/31/16
6. Prostate MRI used as part of RT treatment planning
7. No previous hormonal therapy, such as LHRH agonists, estrogens, anti-androgens, or surgical castration
8. No previous use of finasteride within 30 days prior to planning
9. No previous use of dutasteride within 90 days prior to planning
* High-risk inclusion criteria (as per RTOG 0521)
1. Histologically confirmed prostate adenocarcinoma
2. PSA \< 150
3. One of the following combinations:
1. Gleason 7 or 8 and PSA \>= 20
2. Gleason 8 and clinical T-stage \> T2a
3. Gleason 9 or 10
4. Negative bone scan within 180 days of planning
5. XRT treatment initiated between 1/1/15 and 12/31/16
6. Prostate MRI used as part of RT treatment planning
7. No previous hormonal therapy, such as LHRH agonists, estrogens, anti-androgens, or surgical castration, prior to prostate cancer diagnosis
* Intermediate-risk inclusion criteria
1. Histologically confirmed prostate adenocarcinoma
2. PSA \< 20
3. Gleason 7 or 8
4. Not meeting criteria for favorable- or high-risk disease, as per above
5. XRT treatment initiated between 1/1/15 and 12/31/16
6. Prostate MRI used as part of RT treatment planning
7. No previous hormonal therapy, such as LHRH agonists, estrogens, anti-androgens, or surgical castration, prior to prostate cancer diagnosis
Exclusion Criteria:
1. Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years
2. Evidence of distant metastases
3. Regional lymph node involvement
4. Previous radical prostate surgery or cryosurgery
5. Previous pelvic irradiation or prostate brachytherapy
6. Previous or concurrent cytotoxic chemotherapy for prostate cancer
7. Severe, active comorbidity, defined as follows:
1. Unstable angina, congestive heart failure, and/or transmural myocardial infarction requiring hospitalization within the last 6 months
2. Acute bacterial or fungal infection requiring intravenous antibiotics
3. Hepatic insufficiency resulting in clinical jaundice or coagulopathy
4. Acquired immune deficiency syndrome based upon current CDC-defined criteria
8. Zubrod performance status 2 or worse
9. Previous use of finasteride within 60 days of planning
10. Previous use of dutasteride within 180 days of planningReferences
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