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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

18 Years
Open (Enrolling)
Conditions Influencing Health Status, Healthy, Prostate Cancer

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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


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

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.

Inclusion Criteria:

- All men who will be undergoing transrectal ultrasound of the prostate (TRUSP) with
biopsy in the department of Urology or participating urology clinics for the
evaluation of prostate cancer

Exclusion Criteria:

- Men with a previous diagnosis of prostate cancer

- Men without a prior diagnosis of prostate cancer but who have previously undergone a
biopsy for a suspicious DRE or PSA

- Men with a prior diagnosis of cancer < 5 years ago, excluding basal cell carcinoma
and/or squamous cell carcinoma

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Determine whether EPS or PMU is a better predictor of prostate cancer biopsy results by measuring and comparing the number of prostatic cells collected

Outcome Description:

Compare assay results in 300 EPS specimens with those from 300 PMU specimens. The gold standard for assay validity is the biopsy result.

Outcome Time Frame:

1 month after sample collection

Safety Issue:


Principal Investigator

Timothy Wilson

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2009

Completion Date:

Related Keywords:

  • Conditions Influencing Health Status
  • Healthy
  • Prostate Cancer
  • Health status unknown
  • healthy,no evidence of disease
  • Prostatic Neoplasms



City of Hope Medical Center Duarte, California  91010
City of Hope- South Pasadena Cancer Center South Pasadena, California  91030
Chinn & Chinn Urology Associates, Inc. Arcadia, California  91006
Citrus Valley Urologic Medical Group Glendora, California  91741
Dr. Felix Chi-Ming Yip Monterey Park, California  91754