UCI 03-72 Prostate Cancer Detection by Serum Proteomic Profiling

Prostate Cancer Clinical Trial

Official title:

Prostate Cancer Detection by Serum Proteomic Profiling

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00355758
• Other study ID #: 2004-3561
• Status: Terminated
• Phase: N/A
• First received: July 24, 2006
• Last updated: August 31, 2010
• Start date: April 2005
• Est. completion date: June 2009

Study information

• Verified date: August 2010
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	University of California, Irvine	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States,