Study in Predicting Outcome of Patients Undergoing Radiation Therapy for Prostate Cancer
NCT ID: NCT00045331
Last Updated: 2013-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
2002-08-31
2007-10-31
Brief Summary
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PURPOSE: Diagnostic trial to study blood and urine proteins in predicting treatment outcome in patients who are undergoing radiation therapy for prostate cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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DIAGNOSTIC
Interventions
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proteomic profiling
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Principal Investigators
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Kevin Camphausen, MD
Role: STUDY_CHAIR
NCI - Radiation Oncology Branch; ROB
Locations
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Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
NCI - Center for Cancer Research
Bethesda, Maryland, United States
Countries
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Other Identifiers
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NCI-02-C-0226
Identifier Type: -
Identifier Source: secondary_id
CDR0000256868
Identifier Type: -
Identifier Source: org_study_id
NCT00039806
Identifier Type: -
Identifier Source: nct_alias
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