NCT00355758

Brief Summary

: Researchers would like to see if a new test called SELDI (Surface Enhanced Laser Desorption Ionization) analysis can predict biopsy results better than PSA tests.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

September 1, 2010

Status Verified

August 1, 2010

First QC Date

July 24, 2006

Last Update Submit

August 31, 2010

Conditions

Prostate Cancer

Keywords

Prostate Cancer Detection by Serum Proteomic Profiling

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those who have prostate cancer and are scheduled for robotic prostatectomy to treat the disease and are seen at the Urology Clinic of the University of California, Irvine.

You may qualify if:

  • For all subjects:
  • Men 50 years of age or older.
  • Serum PSA greater than or equal to 2.5 ng/ml and less then or equal to 10.0 ng/ml determined by a measurement within the past six months, and/or digital rectal exam suspicious for prostate cancer as determined by the patient's Urologist.
  • It has been determined by the treating physician that a prostate biopsy is clinically indicated.
  • Patients will have already been diagnosed with prostate cancer and scheduled for a radical prostatectomy.
  • For study on treatment effect
  • Men with clinically localized prostate cancer (total PSA \< 20 ng/ml and clinical T2b or less).
  • Men with organ confined prostate cancer as determined by final pathologic diagnosis.

You may not qualify if:

  • Known prostate cancer or prior treatment for prostate cancer.
  • Acute prostatitis.
  • Untreated urinary tract infection.
  • Presence of Foley catheter or any urethral instrumentation in the previous 48 hours.
  • Hormonal therapies including LHRH agonists, oral anti-androgens, estrogenic compounds, Proscar or any phytotherapies within the previous 6 months.
  • Men with non-organ confined prostate cancer.
  • Men with detectable serum PSA levels more than 1 months following radical prostatectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Irvine

Orange, California, 92868, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood is collected from subjects. The whole blood is spun down by centrifugation and only serum is retained and stored.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Atreaya Dash, MD

    University of California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2006

First Posted

July 25, 2006

Study Start

April 1, 2005

Study Completion

June 1, 2009

Last Updated

September 1, 2010

Record last verified: 2010-08

Locations

US(1)