Comparing the Reliability of Expressed Prostatic Secretion (EPS) and Post Massage Urine (PMU) for the Prediction of Prostate Cancer Biopsy Outcome

This randomized pilot phase I trial studies the best way, either expressed prostatic secretion (EPS) or post massage urine (PMU) biomarkers, of predicting biopsy results in patients undergoing prostate biopsy. Studying samples of urine in the laboratory may help doctors detect prostate cancer. It is not yet known whether EPS or PMU biomarkers are more effective in predicting prostate biopsy results

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy; Prostate Cancer; Conditions Influencing Health Status
• Intervention / Treatment: Other: laboratory biomarker analysis; Procedure: transrectal prostate biopsy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (PMU); Patients receive digital rectal palpation and then void a spontaneous urine sample for PMU analysis. Patients then undergo a prostate biopsy.	Other: laboratory biomarker analysis; Correlative studies; Procedure: transrectal prostate biopsy; Undergo prostate biopsy
Experimental: Arm II (EPS); 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.	Other: laboratory biomarker analysis; Correlative studies; Procedure: transrectal prostate biopsy; Undergo prostate biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine whether EPS or PMU is a better predictor of prostate cancer biopsy results by measuring and comparing the number of prostatic cells collected	Compare assay results in 300 EPS specimens with those from 300 PMU specimens. The gold standard for assay validity is the biopsy result.	1 month after sample collection
Comparison of the area under the curve (AUC) for sensitivity and specificity of TMPRSS2:ERG single and double fusion assays and biopsy results in patients with prostate cancer, undergoing prostate screening	Perform TMPRSS2:ERG type III and TMPRSS2:ERG type IV assays on each specimen. The gold standard for assay validity is the biopsy result.	1 month after sample collection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the AUC for sensitivity and specificity of the methylation status of the androgen receptor (AR) and GSTP1 promoter, APC and RARB and biopsy results in men with prostate cancer, undergoing prostate screening	The gold standard for assay validity is the biopsy result.	1 month after sample collection
Determine by comparison of AUCs which combination of molecular markers offers the greatest improvements in our ability to predict biopsy outcome over current baseline predictors (serum PSA and DRE)	The gold standard for assay validity is the biopsy result.	1 month after sample collection
Comparison through the AUCs of the association of EPS or PMU TMPRSS2:ERG fusion assay and methylation of the GSTP1 promoter, APC, RARB assays and PCA3 to the results of TRUSP and biopsy in men with unknown prostate cancer status	The gold standard for assay validity is the biopsy result.	1 month after sample collection

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Steven Smith, PhD, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2009
• Primary Completion (Actual): June 30, 2016
• Study Completion (Estimated): February 3, 2027

Study Registration Dates

• First Submitted: September 23, 2011
• First Submitted That Met QC Criteria: September 27, 2011
• First Posted (Estimated): September 28, 2011

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Health status unknown; healthy,no evidence of disease
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 08239; NCI-2017-00089 (Registry Identifier: CTRP (Clinical Trial Reporting Program))