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

Tracking Information

First Received Date ^ICMJE

September 6, 2002

Last Updated Date

February 6, 2009

Start Date ^ICMJE

August 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00045331 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Genetic: proteomic profiling

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00045331

Responsible Party

Study ID Numbers ^ICMJE

CDR0000256868, NCI-02-C-0226

Study Sponsor ^ICMJE

National Cancer Institute (NCI)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Kevin Camphausen, MD

NCI - Radiation Oncology Branch; ROB

Information Provided By

National Cancer Institute (NCI)

Verification Date

October 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP