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

Sponsoren

Hauptsponsor: National Cancer Institute (NCI)

Quelle National Cancer Institute (NCI)
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Completed
Anfangsdatum August 2002
Fertigstellungstermin October 2007
Phase N/A
Studientyp Interventional
Bedingung
Intervention

Interventionsart: Genetic

Interventionsname: proteomic profiling

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: Male

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Kevin Camphausen, MD Study Chair NCI - Radiation Oncology Branch; ROB
Ort
Einrichtung:
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
Standort Länder

United States

Überprüfungsdatum

October 2004

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Studiendesign Info

Hauptzweck: Diagnostic

Quelle: ClinicalTrials.gov