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Prostate Cancer Detection by Serum Proteomic Profiling

50 Years
Not Enrolling
Prostate Cancer

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Trial Information

Prostate Cancer Detection by Serum Proteomic Profiling

A blood sample of approximately 30 cc will be collected prior to the patients standard of
care radical prostatectomy surgery. This blood will be used for the SELDI analysis. The
remainder of the blood sample will be stored and may be used for the PSA test at a later
date. The patient will have a final blood draw 3 months to 1 year following surgery.

Inclusion Criteria:

- 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

- 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.

Exclusion Criteria:

- 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

- 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Atreaya Dash, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California


United States: Institutional Review Board

Study ID:




Start Date:

April 2005

Completion Date:

June 2009

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer Detection by Serum Proteomic Profiling
  • Prostatic Neoplasms



University of California, Irvine Orange, California  92868