Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00773773
NCT00773773CompletedNot Applicable

A Study to Assess if a 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

Memorial Sloan Kettering Cancer Center4 sites in 1 country500 target enrollmentStarted: October 14, 2008Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
500
Locations
4
Primary Endpoint
To Determine if Men With Prostate Cancer Have a Different Proteomic Profile Than Men Without Cancer. Cancer-free Status Will be Confirmed by a Re-biopsy at 6 Months to Reduce the Biopsy False Negative Rate to Less Than 5 %.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 on biopsy from men with no cancer on biopsy.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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 Criteria

  • •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

Outcomes

Primary Outcomes

To Determine if Men With Prostate Cancer Have a Different Proteomic Profile Than Men Without Cancer. Cancer-free Status Will be Confirmed by a Re-biopsy at 6 Months to Reduce the Biopsy False Negative Rate to Less Than 5 %.

Time Frame: conclusion of study

To Determine Whether the Peptide Proteomic Profile Can Improve the Predictive Ability of Known Serum Biomarkers (PSA (Free and Total), hK2 and Su-PAR) for Prostate Cancer.

Time Frame: conclusion of the study

Secondary Outcomes

  • To Determine if Caucasian Men and Men of African-American Descent With and Without Prostate Cancer Have Different Proteomic Profiles.(conclusion of the study)
  • To Assess Reproducibility of Proteomic Profiles Over Different Runs, Platforms, and Sites.(conclusion of the study)
  • To Procure a DNA Repository From These Patients Undergoing Prostate Biopsy for Future Assessment of Kallikrein Gene Expression.(conclusion of the study)
  • To Establish a Bank of DNA, Serum, and Frozen Lymphoblastoid Cells From These Patients for the Purpose of Enabling Genetic Investigations in Men With a Diagnosis of Prostate Cancer.(conclusion of the study)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

Loading locations...

Similar Trials

Unknown
Not Applicable
A Research for Combination of Prostate Health Index (Phi) and mpMRI PI-RADS in the Diagnosis of Prostate CancerProstate Cancer
NCT05179707Qilu Hospital of Shandong University936
Completed
Not Applicable
Validation of the Stockholm3 Test for Detection of Prostate Cancer in the Swiss PopulationLocalized CarcinomaProstate Cancer
NCT05294627University Hospital, Basel, Switzerland380
Completed
Not Applicable
Multicentric Comparative Prospective Study of the Benefits and Risks of Biopsy Prostate Using Transrectal or Transperineal Procedure for the Prostate Cancer DiagnosticPatients With Suspected Prostate Cancer
NCT05763355Elsan101
Completed
Not Applicable
Proteomic Profiling in Diagnosing Non-Small Cell Lung Cancer in Patients Who Are Undergoing Lung Resection for Suspicious Stage I Lung LesionsLung Cancer
NCT00077324Alliance for Clinical Trials in Oncology1,000
Unknown
Not Applicable
Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and BiomarkersProstate Cancer
NCT02844829Turku University Hospital200