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PCA3 Validation Study and Urinary Reference Set

Wei, JohnUniversity of Michigan
Feng, ZidingFred Hutchinson Cancer Research Center

No involved investigator sites defined.

Prostate and Urologic Cancers Research Group

see Publication

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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