UCI 03-72 Prostate Cancer Detection by Serum Proteomic Profiling
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00355758
Recruitment Status :
(Lack of personnel)
: 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.
Condition or disease
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
50 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Those who have prostate cancer and are scheduled for robotic prostatectomy to treat the disease and are seen at the Urology Clinic of the University of California, Irvine.
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 for all subjects:
Known prostate cancer or prior treatment for prostate cancer.
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.