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

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: September 6, 2002
Last updated: June 18, 2013
Last verified: October 2004

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 Intervention
Prostate Cancer Genetic: proteomic profiling

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2002
Study Completion Date: October 2007
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed prostate cancer
  • Completed or planned definitive radiotherapy



  • Adult

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


Biologic therapy

  • Concurrent immunotherapy allowed


  • Concurrent chemotherapy allowed

Endocrine therapy

  • Concurrent hormonal therapy allowed


  • See Disease Characteristics
  • Concurrent palliative radiotherapy allowed


  • No prior prostatectomy, including radical prostatectomy
  • No concurrent radical prostatectomy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: Kevin Camphausen, MD NCI - Radiation Oncology Branch; ROB
  More Information Identifier: NCT00045331     History of Changes
Obsolete Identifiers: NCT00039806
Other Study ID Numbers: CDR0000256868
Study First Received: September 6, 2002
Last Updated: June 18, 2013

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on September 20, 2017