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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
proteomic profiling
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
  • NCI - Center for Cancer Research

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 6, 2002
Last Updated
June 18, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00045331
Brief Title
Study in Predicting Outcome of Patients Undergoing Radiation Therapy for Prostate Cancer
Official Title
Are the Proteomic Profiles of Serum and Urine Predictivefor Clinical Outcome After Definitive Radiotherapy for Localized Prostate Cancer? A Preliminary Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2004
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
proteomic profiling

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Camphausen, MD
Organizational Affiliation
NCI - Radiation Oncology Branch; ROB
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States
Facility Name
NCI - Center for Cancer Research
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

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

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