Clinical trial NCT00773773: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Elevated Prostate Specific Antigen (PSA)
Keywords: Biomarkers - PSA, hK2 and solubilized
urokinase-receptor forms (su-PAR)
08-114
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: New York Presbyterian Hospital
name: Weill Medical College of Cornell University
name: State University of New York - Downstate Medical Center
name: NYU Langone Health
name: Kings County Hospital Department of Emergency Medicine
First posted: 2008-10-16
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

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 %.
timeFrame: conclusion of study
measure: 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.
timeFrame: 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.
timeFrame: conclusion of the study
measure: To Assess Reproducibility of Proteomic Profiles Over Different Runs, Platforms, and Sites.
timeFrame: conclusion of the study
measure: To Procure a DNA Repository From These Patients Undergoing Prostate Biopsy for Future Assessment of Kallikrein Gene Expression.
timeFrame: conclusion of the study
measure: 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.
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Kings County Hopsital Center
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center (DMC)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All protocol activites)
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Paul Tempst, PhD
role: PRINCIPAL_INVESTIGATOR
References: