UCI 03-72 Prostate Cancer Detection by Serum Proteomic Profiling

NCT ID: NCT00355758

Last Updated: 2010-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

: 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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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.


* Men with non-organ confined prostate cancer.
* Men with detectable serum PSA levels more than 1 months following radical prostatectomy.
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of California, Irvine

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Atreaya Dash, MD

Role: PRINCIPAL_INVESTIGATOR

University of California

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, Irvine

Orange, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2004-3561

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Early Detection of Prostate Cancer
NCT04556916 RECRUITING NA