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 Center (MSK)

Status: Terminated

Conditions: Elevated Prostate Specific Antigen (PSA); Prostate Cancer

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00773773

08-114

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

58 participants in 1 patient group

Patients undergoing prostatic biopsy

Experimental group

Description:

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.

Treatment:

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