Abbreviated Name

Prostate-PCA3

Lead Investigator

Wei, John — University of Michigan Recruiting

Coordinating Investigator

Zheng, Yingye — Fred Hutchinson Cancer Center

Involved Investigators

• Groskopf, Jack — Hologic Gen-Probe Incorporated
• — Johns Hopkins University Department of Urology
• Kibel, Adam — Brigham and Womens Hospital
• Wei, John — University of Michigan Recruiting
• Wagner, Andrew — Beth Israel Deaconess Medical Center
• Lin UW, Daniel W. — University of Washington
• Chan, Daniel — Johns Hopkins Medical Institutions
• Leach, Robin J — University of Texas Health Science Center at San Antonio
• Lotan, Yair — UT Southwestern Medical Center at Dallas
• Diaz-Mayoral, Norma — Frederick National Laboratory for Cancer Research
• Srivastava, Sudhir — National Cancer Institute
• Sanda, Martin — Emory University
• Busby, Erik — Greenville Health System
• Hoerres, Mike — Source MDx
• Zheng, Yingye — Fred Hutchinson Cancer Center

Abstract

Independent of serum PSA level, PCA3 score will refine the risk of having cancer detected on an extended template prostate biopsy.

Aims

Primary Specific Aims Aim 1:   To evaluate the PPV of PCA3 for initial biopsy population and NPV of PCA3 for repeat biopsy population in a multi-center prostate biopsy cohort of men without prior history of prostate cancer Aim 2:   To develop a novel urinary reference set consisting of whole urine /urine sediment as well as plasma/serum necessary for future pre-validation studies of urinary biomarkers. Secondary Aims Aim 1:   To evaluate the sensitivity, specificity, PPV, NPV, and absolute risk prediction by PCA3 alone and multiplexed with other biomarkers and clinical variables in the detection of prostate cancer overall, and in the detection of high grade cancer Aim 2:   To evaluate the correlation between PCA3 and prostate biopsy tumor grade

Analytic Method

PCA3 testing of processed urine specimens will take place at John Hopkins University (Dr Sokoll) and Gen-Probe (Dr. Groskopf) (see Appendix 5). Testing will be performed and analyzed according to the method described by Groskopf(8). The Hopkins EDRN Biomarker Reference Laboratory will assay 100% of the samples and the Gen-Probe laboratory will assay 10% as quality control. Processed urine specimens will be tested in duplicate at both laboratories with the PCA3 Assay on the Gen-Probe Systems. The calibration curve will be tested in triplicate and the controls will be tested in duplicate. The mRNA results for PCA3 and PSA for each subject must be generated from the same processed urine specimen tube.

Outcome

Independent of serum PSA level, PCA3 score will refine the risk of having cancer detected on an extended template prostate biopsy.

Publications

• Can urinary PCA3 supplement PSA in the early detection of prostate cancer?

Biomarkers

• MiPS (Mi Prostate Score Urine test)
• PCA3

Data Collections

• No data collections available at this time for this protocol.

Start Date

Jan 16 2009

Estimated Finish Date

Jan 15 2012

Finish Date

Mar 31 2012

Protocol ID

274

Protocol Type

Validation

Fields of Research

• Proteomics

Collaborative Group

Prostate and Urologic Cancers Research Group

Cancer Types

• Malignant neoplasm of prostate

Phased Status

2