Early Prostate Cancer: Predicting Treatment Response
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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.
Condition or disease
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.
Prostate-Cancer-specific change in quality of life [ Time Frame: Day of enrollment, 6-months, and 12-months after enrollment ]
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.
Secondary Outcome Measures :
Recurrence of cancer [ Time Frame: EMR data abstraction around the 6-month time point after enrollment ]
Recurrence will be recorded from data abstraction from the electronic medical records (EMR).
Complications of treatment [ Time Frame: EMR data abstraction around the 6-month time point after enrollment ]
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:
Gender Based Eligibility:
Gender Eligibility Description:
Since this study is working with prostate cancer, our cohort will only be males.
Accepts Healthy Volunteers:
Our study population will be selected from clinics at 5 major southern California hospitals including: University of California, Irvine, University of California, Los Angeles, Cedars-Sinai Medical Center, Veterans Affair Healthcare Center Long Beach, and Veterans Affair Healthcare Center West Los Angeles.
18 - 90 years of age
Prostate-Specific Antigen (PSA) values <50ng/ml
Clinical stage of T1 or T2
No evidence of metastasis or nodal involvement
Age 91 or greater
Clinically locally advanced or metastatic disease
PSA equal to or greater than 50ng/ml
Diagnosis of malignancy (excluding squamous or basal cell carcinoma of the skin) within 3 years of diagnosis of prostate cancer