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UCI 03-72 Prostate Cancer Detection by Serum Proteomic Profiling

This study has been terminated.
(Lack of personnel)
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00355758
First received: July 24, 2006
Last updated: August 31, 2010
Last verified: August 2010
History of Changes
  Purpose

: 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
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prostate Cancer Detection by Serum Proteomic Profiling

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

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.


Estimated Enrollment: 200
Study Start Date: April 2005
Study Completion Date: June 2009
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders 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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355758

Locations
United States, California
University of California, Irvine
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Atreaya Dash, MD University of California
  More Information

No publications provided

Responsible Party: Atreya Dash, MD, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00355758     History of Changes
Other Study ID Numbers: 2004-3561
Study First Received: July 24, 2006
Last Updated: August 31, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Prostate Cancer Detection by Serum Proteomic Profiling

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013