Trial Information

Determination of the Reliability of Expressed Prostatic Secretion and Post Massage Urine Biomarkers in the Detection of Prostate Cancer in Men Undergoing Biopsy for Prostate Cancer

OBJECTIVES:

I. To determine which non-invasive test for prostate cancer, EPS or PMU, is a better
predictor of prostate cancer biopsy result. (Part I)

II. To determine whether standardized testing for transmembrane protease, serine 2
(TMPRSS2):ERG Types III and VI is superior to testing for TMPRSS2:ERG Type III in predicting
prostate biopsy outcome. (Part I)

III. To expand the sample size utilizing the best TMPRSS2:ERG test and the best specimen
type as determined in objective I and II in order to estimate with reasonable accuracy the
positive predictive value (PPV) and negative predictive value (NPV) for each test. (Part II)

IV. To expand the biomarker set, to include Prostate Cancer Antigen 3 (PCA3)-ribonucleic
acid (RNA), d-glyceraldehyde-3-phosphate dehydrogenase (GADPH)-RNA, prostate-specific
antigen (PSA)-RNA, and deoxyribonucleic acid (DNA) methylation levels at glutathione
s-transferase pi (GSTP1), adenomatous polyposis coli (APC), retinoic acid receptor beta
(RARB), Mitochondrial DNA (MT-DNA) Deletions and ras association (RalGDS/AF-6) domain family
1 (RASSF1), so as to develop an extensive data set for use in multivariate analysis. (Part
II)

V. Use multivariate analysis to determine which combination of molecular markers offers the
greatest improvements in our ability to predict biopsy outcome over current baseline
predictors (Serum PSA and digital rectal examination [DRE]). (Part II)

VI. Estimate PPV and NPVs from this analysis and compare them to the standard assay's
performance. (Part II)

OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive digital
rectal palpation and then void a spontaneous urine sample for PMU analysis. Patients then
undergo a prostate biopsy.

ARM II: Patients receive DRE with prostatic massage for 30-60 seconds and are then milked at
the urethra to provide a collection of EPS. Patients then undergo a prostate biopsy.