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Molecular Urine Tests for Prostate Cancer

This study is currently recruiting participants.
Verified by University of California, Irvine, June 2008

Sponsors and Collaborators: University of California, Irvine
Gen-Probe, Inc.
Information provided by: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00581516
  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

MedlinePlus related topics:   Cancer    Prostate Cancer   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective

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

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

Blood and Urine


Estimated Enrollment:   100
Study Start Date:   March 2007
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   December 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581516

Contacts
Contact: Rosanne Santos     714-456-8176     rtsantos@uci.edu    

Locations
United States, California
University of California, Irvine Medical Center     Recruiting
      Orange, California, United States, 92868
      Principal Investigator: David Ornstein, MD            
      Sub-Investigator: Thomas Ahlering, MD            

Sponsors and Collaborators
University of California, Irvine
Gen-Probe, Inc.

Investigators
Principal Investigator:     David Ornstein, MD     University of California, Irvine    
  More Information


Responsible Party:   University of California, Irvine ( David Ornstein, MD )
Study ID Numbers:   2006-5107
First Received:   December 19, 2007
Last Updated:   June 16, 2008
ClinicalTrials.gov Identifier:   NCT00581516
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 15, 2008




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