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


Condition: Prostate Cancer, Artificial Intelligence, Radiotherapy

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04441775

Sponsor: Dartmouth-Hitchcock Medical Center

Phase:

Eligibility:

  • Age: minimum 21 Years maximum 90 Years
  • Gender: Male

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:
  8. Unstable angina, congestive heart failure, and/or transmural myocardial infarction requiring hospitalization within the last 6 months
  9. Acute bacterial or fungal infection requiring intravenous antibiotics
  10. Hepatic insufficiency resulting in clinical jaundice or coagulopathy
  11. Acquired immune deficiency syndrome based upon current CDC-defined criteria
  12. Zubrod performance status 2 or worse
  13. Previous use of finasteride within 60 days of planning
  14. Previous use of dutasteride within 180 days of planning

View trial on ClinicalTrials.gov


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