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
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Maryland
-
Bethesda, Maryland, États-Unis, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
-
Bethesda, Maryland, États-Unis, 20892
- NCI - Center for Cancer Research
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Kevin Camphausen, MD, NCI - Radiation Oncology Branch; ROB
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CDR0000256868
- NCI-02-C-0226
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .