Prostate Cancer Clinical Trial

Early Prostate Cancer: Predicting Treatment Response

Summary

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.

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Full Description

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.

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Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

693

Study ID:

NCT03770351

Recruitment Status:

Recruiting

Sponsor:

University of California, Irvine

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There are 5 Locations for this study

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University of California, Irvine
Irvine California, 92697, United States
Veterans Affair Long Beach Healthcare System
Long Beach California, 90822, United States
Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
University of California, Los Angeles
Los Angeles California, 90095, United States
Veterans Affair West Los Angeles Healthcare System
West Los Angeles California, 90073, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

693

Study ID:

NCT03770351

Recruitment Status:

Recruiting

Sponsor:


University of California, Irvine

How clear is this clinincal trial information?

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