Early Prostate Cancer: Predicting Treatment Response



Status:Active, not recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 90
Updated:2/24/2019
Start Date:January 2017
End Date:April 30, 2019

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

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.

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
We found this trial at
5
sites
Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Irvine, California 92697
949-824-5011
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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Irvine, CA
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Long Beach, California 90822
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Long Beach, CA
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West Los Angeles, California 90073
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West Los Angeles, CA
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