Study in Predicting Outcome of Patients Undergoing Radiation Therapy for Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Genetic: proteomic profiling


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer Completed or planned definitive radiotherapy PATIENT CHARACTERISTICS: Age Adult Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified PRIOR CONCURRENT THERAPY: Biologic therapy Concurrent immunotherapy allowed Chemotherapy Concurrent chemotherapy allowed Endocrine therapy Concurrent hormonal therapy allowed Radiotherapy See Disease Characteristics Concurrent palliative radiotherapy allowed Surgery No prior prostatectomy, including radical prostatectomy No concurrent radical prostatectomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: proteomic profiling|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer