Pre-Surgical EPS Biomarkers as Predictors of Biochemical Recurrence
PRIMARY OBJECTIVES: I. To explore the performance of these models in predicting the
likelihood of biochemical recurrence (BCR).
SECONDARY OBJECTIVES: I. To explore the performance of these models in predicting upgrading
and upstaging prior to surgery. II. To explore the performance of these models in improving
risk stratification among patients eligible for active surveillance.
OUTLINE: Patients receive prostatic massage and undergo a digital rectal exam (DRE).
Laboratory assessments are performed and blood samples are collected for molecular biology
testing. On the day of the scheduled prostatectomy, a second blood collection is performed
prior to surgery.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Performance of this model in predicting the likelihood of BCR
Logistic regression and artificial neural networks will be used.
Visit 2 (intraoperative setting)
Steven S. Smith, PhD
City of Hope Medical Center
United States: Institutional Review Board
|City of Hope Medical Center||Duarte, California 91010|