Molecular Urine Tests for Prostate Cancer

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00581516
• Lead Sponsor: University of California, Irvine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-27
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-03
• Last Update Posted: 2009-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• minors

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of California, Irvine Medical Center; 🇺🇸 Orange, California, United States