EPS vs PMU Biomarkers for Predicting Prostate Cancer Biopsy Outcomes

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen bySteven Smith, PhD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for men scheduled to undergo a prostate ultrasound and biopsy at specific urology departments or clinics. It's designed to evaluate the best method of predicting prostate cancer biopsy results using either EPS or PMU biomarkers.

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

Treatment Details

Interventions

Laboratory Biomarker Analysis (Other)
Transrectal Prostate Biopsy (Procedure)

Trial OverviewThe study is testing whether expressed prostatic secretion (EPS) or post massage urine (PMU) is more reliable in predicting the outcome of a prostate cancer biopsy. Participants will be randomly assigned to have one of these biomarker analyses before their biopsy.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Arm II (EPS)Experimental Treatment2 Interventions

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 II: Arm I (PMU)Experimental Treatment2 Interventions

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