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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00045331

Enrollment

Unknown

Registered

2003-01-27

Start date

2002-08-31

Completion date

2007-10-31

Last updated

2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

Brief summary

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

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.

Interventions

GENETICproteomic profiling

Study design

Primary purpose

DIAGNOSTIC

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026