Overview

This trial is active, not recruiting.

Conditions prostate cancer, elevated prostate specific antigen (psa)
Treatment serum specimens obtained will be utilized for proteomic profiling comprising maldi-tof ms, and serum biomarker assays.
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator National Institutes of Health (NIH)
Start date October 2008
End date October 2016
Trial size 500 participants
Trial identifier NCT00773773, 08-114

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
This study will enroll two groups of 250 patients who are to undergo prostatic biopsy as part of their routine medical care because of suspicion of prostate cancer (elevated PSA between 2 and 10 ng/ml, abnormal rectal examination, or both). The first group will contain 250 patients of African-American descent and the second will contain 250 Caucasian men.
serum specimens obtained will be utilized for proteomic profiling comprising maldi-tof ms, and serum biomarker assays.
Patients referred for prostate biopsy as part of their routine care are to be recruited. Patients will undergo standard medical evaluation/care by undergoing a prostate biopsy because of an elevated PSA blood test and/or an abnormal digital rectal prostate examination. The protocol involves obtaining the research blood sample at the time of routine pre-biopsy blood draw. As such, an extra five (40 mL) tubes of blood will be drawn. The serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays.

Primary Outcomes

Measure
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

Measure
To determine if Caucasian men and men of African-American descent with and without prostate cancer have different proteomic profiles.
time frame: conclusion of the study
To assess reproducibility of proteomic profiles over different runs, platforms, and sites.
time frame: conclusion of the study
To procure a DNA repository from these patients undergoing prostate biopsy for future assessment of kallikrein gene expression.
time frame: 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.
time frame: conclusion of the study

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title 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
Principal investigator Paul Tempst, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.