UCI 03-72 Prostate Cancer Detection by Serum Proteomic Profiling

Stopped early

Conditions studied: Prostate Cancer

In brief

: Researchers would like to see if a new test called SELDI (Surface Enhanced Laser Desorption Ionization) analysis can predict biopsy results better than PSA tests.

Key facts

Study ID

NCT00355758

Run by

University of California, Irvine

People needed

200

Starts

2005-04-01

Expected to finish

2009-06-01

Last updated by the study team

2010-09-01

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• For all subjects:
• Men 50 years of age or older.
• Serum PSA greater than or equal to 2.5 ng/ml and less then or equal to 10.0 ng/ml determined by a measurement within the past six months, and/or digital rectal exam suspicious for prostate cancer as determined by the patient's Urologist.
• It has been determined by the treating physician that a prostate biopsy is clinically indicated.
• Patients will have already been diagnosed with prostate cancer and scheduled for a radical prostatectomy.
• For study on treatment effect
• Men with clinically localized prostate cancer (total PSA < 20 ng/ml and clinical T2b or less).
• Men with organ confined prostate cancer as determined by final pathologic diagnosis.

You may not qualify if…

• Exclusion criteria for all subjects:
• Known prostate cancer or prior treatment for prostate cancer.
• Acute prostatitis.
• Untreated urinary tract infection.
• Presence of Foley catheter or any urethral instrumentation in the previous 48 hours.
• Hormonal therapies including LHRH agonists, oral anti-androgens, estrogenic compounds, Proscar or any phytotherapies within the previous 6 months.
• Exclusion Criteria (for study on treatment effect)
• Men with non-organ confined prostate cancer.
• Men with detectable serum PSA levels more than 1 months following radical prostatectomy.

Where it is running

• University of California, Irvine — Orange, California, United States

Full record on ClinicalTrials.gov

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