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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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
University of California, Irvine Medical Center
Orange, California, United States
Start Date
March 1, 2007
Primary Completion Date
September 1, 2008
Completion Date
September 1, 2008
Last Updated
June 5, 2009
100
ACTUAL participants
Lead Sponsor
University of California, Irvine
NCT06842498
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05691465