Study in Predicting Outcome of Patients Undergoing Radiation Therapy for Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00045331|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Genetic: proteomic profiling||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Study Completion Date :||October 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00045331
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|NCI - Center for Cancer Research|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Kevin Camphausen, MD||NCI - Radiation Oncology Branch; ROB|