Development and validation of a novel automated Gleason grade and molecular profile that define a highly predictive prostate cancer progression algorithm-based test

• Published in: Prostate cancer and prostatic diseases 2018-11, Vol.21 (4), p.594-603
• Main Authors: Donovan, Michael J., Fernandez, Gerardo, Scott, Richard, Khan, Faisal M., Zeineh, Jack, Koll, Giovanni, Gladoun, Nataliya, Charytonowicz, Elizabeth, Tewari, Ash, Cordon-Cardo, Carlos
• Format: Article
• Language: English
• Subjects: 13/1; 13/51; 14/35; 631/67; 692/53; Algorithms; Analysis; Artificial intelligence; Biological markers; Biomarkers; Biomedical and Life Sciences; Biomedicine; Cancer; Cancer metastasis; Cancer Research; Cancer surgery; Cancer therapies; Cancer treatment; Chemotherapy; Deprivation; Development and progression; Digital imaging; Evaluation; Failure; Hazards; Health risks; Image analysis; Image processing; Learning algorithms; Machine learning; Mathematical models; Medical research; Medical schools; Metastases; Patients; Pattern analysis; Predictions; Prostate cancer; Prostatectomy; Radiation; Radiation (Physics); Risk assessment; Surgery; Training; Urological surgery
• ISSN: 1365-7852; 1476-5608
• DOI: 10.1038/s41391-018-0067-4

Background Postoperative risk assessment remains an important variable in the effective treatment of prostate cancer. There is an unmet clinical need for a test with the potential to enhance the Gleason grading system with novel features that more accurately reflect a personalized prediction of clinical failure. Methods A prospectively designed retrospective study utilizing 892 patients, post radical prostatectomy, followed for a median of 8 years. In training, using digital image analysis to combine microscopic pattern analysis/machine learning with biomarkers, we evaluated Precise Post-op model results to predict clinical failure in 446 patients. The derived prognostic score was validated in 446 patients. Eligible subjects required complete clinical-pathologic variables and were excluded if they had received neoadjuvant treatment including androgen deprivation, radiation or chemotherapy prior to surgery. No patients were enrolled with metastatic disease prior to surgery. Evaluate the assay using time to event concordance index (C-index), Kaplan–Meier, and hazards ratio. Results In the training cohort ( n  = 306), the Precise Post-op test predicted significant clinical failure with a C-index of 0.82, [95% CI: 0.76–0.86], HR:6.7, [95% CI: 3.59–12.45], p