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CompletedNCT00045331Updated Jun 19, 2013

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

An interventional study of proteomic profiling in Prostate Cancer, sponsored by National Cancer Institute (NCI). Completed at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-19.

Sponsored by National Cancer Institute (NCI) · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • recurrent prostate cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
03

In context

Prostatic Neoplasms

6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

Browse Prostatic Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,505 studies on the registry; 333 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic

Interventions

  • Geneticproteomic profiling
06

Study locations

2 sites
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
    Bethesda, Maryland 20892-1182, United States
  • NCI - Center for Cancer Research
    Bethesda, Maryland 20892, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00045331
Lead sponsor
National Cancer Institute (NCI)
First posted
Jan 27, 2003
Start date
Aug 2002
Completion
Oct 2007
Last update
Jun 19, 2013

Study contacts

Kevin Camphausen, MD
study chair · NCI - Radiation Oncology Branch; ROB
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2004. You cannot join it, but the record below documents what was studied.

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