Summary

for males ages 18-90 (full criteria)
at Irvine, California and other locations
study started
estimated completion
Sheldon Greenfield

Description

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.

Official Title

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

Details

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.

Keywords

Prostate Cancergenomicsracial disparitiespatient reported outcomesProstatic Neoplasms

Eligibility

You can join if…

Open to males ages 18-90

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, Irvine
    IrvineCalifornia92697United States
  • Veterans Affair Long Beach Healthcare System
    Long BeachCalifornia90822United States

Lead Scientist

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT03770351
Study Type
Observational [Patient Registry]
Last Updated