UCI 03-72 Prostate Cancer Detection by Serum Proteomic Profiling
This study has been terminated.
(Lack of personnel)
Information provided by:
University of California, Irvine
First received: July 24, 2006
Last updated: August 31, 2010
Last verified: August 2010
: 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.
||Observational Model: Cohort
Time Perspective: Prospective
||Prostate Cancer Detection by Serum Proteomic Profiling
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:
| Study Start Date:
| Study Completion Date:
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.
|Ages Eligible for Study:
||50 Years and older
|Genders 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 study on treatment effect)
- Men with non-organ confined prostate cancer.
- Men with detectable serum PSA levels more than 1 months following radical prostatectomy.
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355758
|University of California, Irvine
|Orange, California, United States, 92868 |
University of California, Irvine
||Atreaya Dash, MD
||University of California
No publications provided
||Atreya Dash, MD, University of California, Irvine
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 24, 2006
||August 31, 2010
||United States: Institutional Review Board
Keywords provided by University of California, Irvine:
Prostate Cancer Detection by Serum Proteomic Profiling
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male