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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00045331
• Other study ID #: CDR0000256868
• Secondary ID: NCI-02-C-0226
• Status: Completed
• Phase: N/A
• First received: September 6, 2002
• Last updated: June 18, 2013
• Start date: August 2002
• Est. completion date: October 2007

Study information

• Verified date: October 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00039806

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Genetic:
• proteomic profiling

Locations

Country	Name	City	State
United States	NCI - Center for Cancer Research	Bethesda	Maryland
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,