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

NCT00773773 | Terminated Results

• 1 other identifier: 08-114
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 4

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.

Conditions

Prostate Cancer; Elevated Prostate Specific Antigen (PSA)

Keywords

Biomarkers - PSA, hK2 and solubilized; urokinase-receptor forms (su-PAR); 08-114

Outcome Measures

Primary Outcomes (2)

• 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 %.

  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.

  conclusion of the study

Secondary Outcomes (4)

• 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

Study Arms (1)

Patients undergoing prostatic biopsy

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.

Other: serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays.

Interventions

serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays. OTHER

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.

Patients undergoing prostatic biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• New York Presbyterian Hospital: collaborator
• Weill Medical College of Cornell University: collaborator
• State University of New York - Downstate Medical Center: collaborator
• NYU Langone Health: collaborator
• Kings County Hospital Department of Emergency Medicine: collaborator

Study Sites (4)

Kings County Hopsital Center

Brooklyn, New York, United States

Location

SUNY Downstate Medical Center (DMC)

Brooklyn, New York, United States

Location

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, 10065, United States

Location

Weill Medical College of Cornell University

New York, New York, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Paul Tempst, PhD
• Organization: Memorial Sloan Kettering Cancer Center

liljah@mskcc.org

212-639-8923

Study Officials

• Paul Tempst, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: October 14, 2008
• Primary Completion: March 8, 2024
• Study Completion: March 8, 2024
• Last Updated: September 4, 2024
• Results First Posted: September 4, 2024

Record last verified: 2024-07

Locations

US (4)