Skip to content

Molecular Urine Tests for Prostate Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00581516
Enrollment
100
Registered
2007-12-27
Start date
2007-03-31
Completion date
2008-09-30
Last updated
2009-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate Cancer, PCA3

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.

Interventions

None listed

Sponsors

University of California, Irvine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* minors

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026