Study in Predicting Outcome of Patients Undergoing Radiation Therapy for Prostate Cancer
RATIONALE: Proteins found in blood and urine samples may help predict outcome and allow doctors to plan more effective treatment.
PURPOSE: Diagnostic trial to study blood and urine proteins in predicting treatment outcome in patients who are undergoing radiation therapy for prostate cancer.
|Study Design:||Primary Purpose: Diagnostic|
|Official Title:||Are the Proteomic Profiles of Serum and Urine Predictivefor Clinical Outcome After Definitive Radiotherapy for Localized Prostate Cancer? A Preliminary Cohort Study|
|Study Start Date:||August 2002|
|Study Completion Date:||October 2007|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045331
|United States, Maryland|
|NCI - Center for Cancer Research|
|Bethesda, Maryland, United States, 20892|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Kevin Camphausen, MD||NCI - Radiation Oncology Branch; ROB|