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Sponsored by: |
University of California, Irvine |
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Information provided by: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00581516 |
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.
Condition |
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Prostate Cancer |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
A total of 100 male subjects who have clinically localized prostate cancer and are scheduled to undergo a radical prostatectomy are anticipated in this study
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California, Irvine Medical Center | |
Orange, California, United States, 92868 |
Principal Investigator: | Atreya Dash, MD | University of California, Irvine |
Responsible Party: | University of California, Irvine ( Atreya Dash, MD ) |
Study ID Numbers: | 2006-5107 |
Study First Received: | December 19, 2007 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00581516 |
Health Authority: | United States: Institutional Review Board |
Prostate Cancer PCA3 |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |