Status:
COMPLETED
Artificial Intelligence for Prostate Cancer Treatment Planning
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
Oregon Health and Science University
University of Massachusetts, Worcester
Conditions:
Prostate Cancer
Artificial Intelligence
Eligibility:
MALE
21-90 years
Brief 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. By understand...
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 metho...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
June 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 4 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04441775
Start Date
June 22 2020
End Date
March 4 2022
Last Update
October 13 2023
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756