COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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. Identifier: NCT00355758
Recruitment Status : Terminated (Lack of personnel)
First Posted : July 25, 2006
Last Update Posted : September 1, 2010
Information provided by:
University of California, Irvine

Brief Summary:
: 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
Prostate Cancer

Detailed Description:
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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prostate Cancer Detection by Serum Proteomic Profiling
Study Start Date : April 2005
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Biospecimen Retention:   Samples Without DNA
Whole blood is collected from subjects. The whole blood is spun down by centrifugation and only serum is retained and stored.

Information from the National Library of Medicine

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.

Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00355758

Layout table for location information
United States, California
University of California, Irvine
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Layout table for investigator information
Principal Investigator: Atreaya Dash, MD University of California
Layout table for additonal information
Responsible Party: Atreya Dash, MD, University of California, Irvine Identifier: NCT00355758    
Other Study ID Numbers: 2004-3561
First Posted: July 25, 2006    Key Record Dates
Last Update Posted: September 1, 2010
Last Verified: August 2010
Keywords provided by University of California, Irvine:
Prostate Cancer Detection by Serum Proteomic Profiling
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases