PCA3 Validation Study and Urinary Reference Set

Abbreviated Name
Prostate-PCA3
Lead Investigator
Wei, JohnUniversity of Michigan Recruiting
Coordinating Investigator
Feng, Ziding Fred Hutchinson Cancer Center
Involved Investigators

Abstact

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.

Publications

Biomarkers

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
Field of Research
Proteomics
Collaborative Group
Prostate and Urologic Cancers Research Group
Cancer Types
  • Malignant neoplasm of prostate
Phased Status
2

Associated Forms