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Molecular Urine Tests for Prostate Cancer
This study has been completed.
Study NCT00581516   Information provided by University of California, Irvine
First Received: December 19, 2007   Last Updated: June 3, 2009   History of Changes

December 19, 2007
June 3, 2009
March 2007
September 2008   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00581516 on ClinicalTrials.gov Archive Site
 
 
 
Molecular Urine Tests for Prostate Cancer
 

Prostate cancer is the second leading cause of cancer related deaths among men in the United States.1 Although still controversial, there is growing evidence that early detection will reduce prostate cancer mortality. Currently the most useful biomarker to aid in early detection is measurement of serum prostate specific antigen (PSA) levels. Despite the value of PSA it has substantial limitations. To overcome the limitations of total PSA testing, there is emerging evidence demonstrating that relevant cancer biomarker can be detected in urine.

Patients who present to the urology clinic for a radical prostatectomy will be asked to enter this study. After obtaining informed consent, the following exam and specimen collection scheduled will be followed:

Visit 1 (pre-op):

Digital Rectal Exam (DRE) - Voided urine collection & serum collection

Visit 2 (time of prostatectomy):

Under anesthesia- catheterized urine collection and serum collection

Visit 3 (approximately 8 days post-prostatectomy):

Catheterized urine collection

Visit 4 (approximately 3 months post-prostatectomy):

Voided urine collection and serum collection

Some patients will not have the serum collection at visits 1, 2, and 4. The patients will be notified as to whether or not their blood will be drawn during the visits. Pre-operative Digital Rectal Exam, urinary catheterization and blood draws are part of standard of care in this patient population with localized prostate cancer. The catheter will be inserted during the time of surgery preparation in the operating room and removed during the post operative clinic appointment.

 
 
Observational
Cohort, Prospective
Prostate Cancer
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
100
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Those scheduled to undergo radical prostatectomy for the treatment of prostate cancer.

Exclusion Criteria:

  • minors
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00581516
Atreya Dash, MD, University of California, Irvine
2006-5107
University of California, Irvine
 
Principal Investigator: Atreya Dash, MD University of California, Irvine
University of California, Irvine
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP