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

National Cancer Institute (NCI)

Status: Completed

Conditions: Prostate Cancer

Treatments: Genetic: proteomic profiling

Study type: Interventional

Funder types: NIH

Identifiers

NCT00045331

NCI-02-C-0226

CDR0000256868

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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