This study will replicate/validate the risk prediction model developed for the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study in a more diverse patient population to assess generalizability of the model as well as evaluate the relative contribution of the Decipher Prostate Cancer Test and ProstateNext Test from Ambry Genetics, to the risk prediction model for estimating treatment outcomes, and thereby improve personalization of treatment options.
The study will contribute a replicable model for improving risk prediction from patient characteristics, clinical severity indicators, and genomic tests to aid in personalizing treatment. The proposed registry would also allow future comparisons of the gene expression used in other competing commercial test. The addition of the suggested genomic classifier and its associations with other patient and clinical characteristics will enhance the ability of future studies, analogous to CEASAR, to accurately predict the risk of tumor aggressiveness in prostate cancer.
Study Type
OBSERVATIONAL
Enrollment
693
University of California, Irvine
Irvine, California, United States
RECRUITINGVeterans Affair Long Beach Healthcare System
Long Beach, California, United States
RECRUITINGCedars-Sinai Medical Center
Los Angeles, California, United States
Prostate-Cancer-specific change in quality of life
Quality of life is measured by the Expanded Prostate Cancer Index Composite (EPIC). The Expanded Prostate Cancer Index Composite \[EPIC\] is a validated instrument for measuring disease-specific function/ The domain scores range from 0 to 100, with higher scores representing better function. Patients will be asked to complete the questionnaires during a consultation visit or remotely. EPIC scores will be collected at baseline, 6 month follow up, and at 12 month follow up via the questionnaire. EPIC scores from each time point will then be compared to look at the change in quality of life over the duration of the study.
Time frame: Day of enrollment, 6-months, and 12-months after enrollment
Recurrence of cancer
Recurrence will be recorded from data abstraction from the electronic medical records (EMR).
Time frame: EMR data abstraction around the 6-month time point after enrollment
Complications of treatment
Complications of treatment will be measured using general scales for identifying complications and severity (the Clavien system) as well as assessment of a priori identified complications that are known to occur with prostate cancer care. This information will be collected from electronic medical records.
Time frame: EMR data abstraction around the 6-month time point after enrollment
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University of California, Los Angeles
Los Angeles, California, United States
RECRUITINGVeterans Affair West Los Angeles Healthcare System
West Los Angeles, California, United States
RECRUITING