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

NCT ID: NCT01441687

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-14
• Study Completion Date: 2026-02-09

Brief Summary

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

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.

Conditions

Conditions Influencing Health Status; Healthy; Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Arm I (PMU)

Patients receive digital rectal palpation and then void a spontaneous urine sample for PMU analysis. Patients then undergo a prostate biopsy.

Group Type: EXPERIMENTAL

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

transrectal prostate biopsy

Intervention Type: PROCEDURE

Undergo prostate biopsy

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.

Group Type: EXPERIMENTAL

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

transrectal prostate biopsy

Intervention Type: PROCEDURE

Undergo prostate biopsy

Interventions

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

transrectal prostate biopsy

Undergo prostate biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

Chinn & Chinn Urology Associates, Inc.

Arcadia, California, United States

City of Hope Medical Center

Duarte, California, United States

Citrus Valley Urologic Medical Group

Glendora, California, United States

Dr. Felix Chi-Ming Yip

Monterey Park, California, United States

City of Hope- South Pasadena Cancer Center

South Pasadena, California, United States

Countries

United States

Other Identifiers

NCI-2017-00089

Identifier Type: REGISTRY

Identifier Source: secondary_id

08239

Identifier Type: -

Identifier Source: org_study_id