Early Prostate Cancer: Predicting Treatment Response

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Precision Medicine for Early Prostate Cancer: Integrating Biological and Patient Complexity Variables to Predict Treatment Response

Conditions
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Prostate Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day of enrollment, 6-months, and 12-months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of cancer | Recurrence will be recorded from data abstraction from the electronic medical records (EMR). | 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. | EMR data abstraction around the 6-month time point after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genomics, racial disparities, patient reported outcomes