Molecular Urine Tests for Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00581516
First received: December 19, 2007
Last updated: June 3, 2009
Last verified: June 2009
  Purpose

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
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Biospecimen Retention:   Samples Without DNA

Blood and Urine


Enrollment: 100
Study Start Date: March 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • minors
  Contacts and Locations
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: NCT00581516

Locations
United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Atreya Dash, MD University of California, Irvine
  More Information

No publications provided

Responsible Party: Atreya Dash, MD, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00581516     History of Changes
Other Study ID Numbers: 2006-5107
Study First Received: December 19, 2007
Last Updated: June 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Prostate Cancer
PCA3

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014