Trial Information

Are the Proteomic Profiles of Serum and Urine Predictivefor Clinical Outcome After Definitive Radiotherapy for Localized Prostate Cancer? A Preliminary Cohort Study

OBJECTIVES:

- Correlate serum and urine protein profiles collected before or after radiotherapy with
clinical outcome in patients with prostate cancer.

- Identify protein profiles that can distinguish between patients with no evidence of
disease and those with biochemical and/or clinical failure.

- Determine whether those serum proteomic profiles consistent with failure can be
identified at early time points in the course of treatment and follow-up of these
patients.

OUTLINE: Patients are stratified according to clinical outcome (prior to radiotherapy vs no
evidence of disease vs biochemical failure vs clinical failure vs clinical outcome not yet
determined).

Urine and blood specimens are collected from patients either before or after definitive
radiotherapy. Samples are analyzed by surface-enhanced laser desorption and ionization
time-of-flight mass spectrometry to develop proteomic patterns.

Results of proteomic profiles do not influence patient care.

PROJECTED ACCRUAL: A total of 150 patients (30 per stratum) will be accrued for this study.