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PCA3 Validation Study and Urinary Reference Set

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Prostate cancer (PCa) is the third leading cause of cancer-related deaths among United States men, accounting for 33% of such diagnosed cancers.(1) An estimated 186,320 new cases of PCa were diagnosed in 2006, with an associated mortality rate of 28,660.(15,16) Unfortunately the current screening tools, PSA and related tests, have limited ability to detect PCa. In fact, the Prostate Cancer Prevention Trial detected PCa in 6.6%, 10.1%, 17%, 23.9% and 26.9% of subjects with “normal” PSA values of <0.5, 0.6-1.0, 1.1-2.0, 2.1-3.0 and 3.1-4.0 ng/ml respectively. Since the majority of men between the ages of 45 and 75 had PSA values of <4.0 ng/ml, it has been suggested that 15% of high-grade cancer cases, were missed due by PSA-only evaluation.(30,33) This study has two primary aims -- to provide necessary data to validate a promising new urinary biomarker for prostate cancer, PCA3 and to create a novel urinary reference set for future validations.

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
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.

No datasets are currently associated with this protocol.


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The final report of the 2013 Cancer Biomarkers Bioinformatics Workshop is now available.

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