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


N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Kevin Camphausen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Radiation Oncology Branch; ROB

Authority:

United States: Federal Government

Study ID:

CDR0000256868

NCT ID:

NCT00045331

Start Date:

August 2002

Completion Date:

October 2007

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
NCI - Center for Cancer ResearchBethesda, Maryland  20892