Status:

TERMINATED

Combination of Serum Measurements of Molecular Biomarkers and Serum Protein Profiling Can be Used to Predict Which Patients Undergoing Prostatic Biopsy Will be Diagnosed With Cancer

Lead Sponsor:

Memorial Sloan Kettering Cancer Center

Collaborating Sponsors:

National Institutes of Health (NIH)

New York Presbyterian Hospital

Conditions:

Prostate Cancer

Elevated Prostate Specific Antigen (PSA)

Eligibility:

MALE

18+ years

Phase:

NA

Brief Summary

This is a prospective, serum proteomics study of men who are to undergo prostate biopsy. The purpose is to determine if proteomic profiles can be used to distinguish between men with prostate cancer o...

Eligibility Criteria

Inclusion

  • Men aged 18 years or older
  • Have a PSA level between 2 and 10 ng/ml
  • May or may not have an abnormal digital rectal examination
  • Scheduled for trans-rectal ultrasound (TRUS) guided systematic prostate biopsy as part of routine medical care. All sites (Department of Urology at SUNY Downstate Medical Center, Brooklyn, the Department of Urology, New York Presbyterian Hospital, Weill Medical College of Cornell University, Manhattan and the Department of Urology, Kings County Hospital) will perform a standardized 14 core biopsy protocol.
  • Signed, informed consent
  • Patient must be able to attend the pre-biopsy blood draw

Exclusion

  • Any period of prior/current treatment with hormonal therapy (LHRH agonist/antagonist,antiandrogen, 5-alpha-reductase inhibitor)
  • Prior pelvic radiation
  • A period of less than 6 months prior/current treatment with an alpha-blocker
  • Previous diagnosis of prostate cancer

Key Trial Info

Start Date :

October 14 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 8 2024

Estimated Enrollment :

58 Patients enrolled

Trial Details

Trial ID

NCT00773773

Start Date

October 14 2008

End Date

March 8 2024

Last Update

September 4 2024

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Kings County Hopsital Center

Brooklyn, New York, United States

2

SUNY Downstate Medical Center (DMC)

Brooklyn, New York, United States

3

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, United States, 10065

4

Weill Medical College of Cornell University

New York, New York, United States