Prostate Cancer Detection by Serum Proteomic Profiling

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
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.

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
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.