NCT01441687

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
243

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Jul 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jul 2009Feb 2027

Study Start

First participant enrolled

July 14, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
10.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2027

Expected
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

7 years

First QC Date

September 23, 2011

Last Update Submit

March 20, 2026

Conditions

Conditions Influencing Health StatusHealthyProstate Cancer

Keywords

Health status unknownhealthy,no evidence of disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

    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)

    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

    1 month after sample collection

Study Arms (2)

Arm I (PMU)

EXPERIMENTAL

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

Other: laboratory biomarker analysisProcedure: transrectal prostate biopsy

Arm II (EPS)

EXPERIMENTAL

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 analysisProcedure: transrectal prostate biopsy

Interventions

laboratory biomarker analysisOTHER

Correlative studies

Arm I (PMU)Arm II (EPS)
transrectal prostate biopsyPROCEDURE

Undergo prostate biopsy

Arm I (PMU)Arm II (EPS)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Chinn & Chinn Urology Associates, Inc.

Arcadia, California, 91006, United States

Location

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Citrus Valley Urologic Medical Group

Glendora, California, 91741, United States

Location

Dr. Felix Chi-Ming Yip

Monterey Park, California, 91754, United States

Location

City of Hope- South Pasadena Cancer Center

South Pasadena, California, 91030, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Steven Smith, PhD

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2011

First Posted

September 28, 2011

Study Start

July 14, 2009

Primary Completion

June 30, 2016

Study Completion (Estimated)

February 3, 2027

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations

US(5)