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 enrollmentOctober 14, 2008

ConditionsProstate Cancer Elevated Prostate Specific Antigen (PSA)

Overview

Phase: N/A
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
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 %.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

October 14, 2008

End Date

March 8, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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)