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EPS vs PMU Biomarkers for Predicting Prostate Cancer Biopsy Outcomes

N/A
Waitlist Available
Led By Steven Smith, PhD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month after sample collection
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether EPS or PMU biomarkers are more effective in predicting prostate biopsy results.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Since this trial involves non-invasive laboratory analysis of biological samples, there are no direct side effects from the interventions being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month after sample collection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month after sample collection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
Determine whether EPS or PMU is a better predictor of prostate cancer biopsy results by measuring and comparing the number of prostatic cells collected
Secondary study objectives
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
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
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)

Side effects data

From 2020 Phase 1 & 2 trial • 88 Patients • NCT02012296
76%
Fatigue
58%
Hot flashes
30%
Diarrhea
30%
Pain
27%
Hyperglycemia
24%
Back pain
18%
Nausea
18%
Dizziness
18%
Dyspnea
18%
Arthralgia
15%
Anorexia
15%
Depression
15%
Anxiety
15%
Hypertension
15%
Edema limbs
15%
Headache
15%
Pain in extremity
12%
Urinary frequency
12%
Constipation
12%
Cough
12%
Fall
12%
Abdominal pain
12%
Arthritis
12%
Bone pain
9%
Urinary incontinence
9%
Insomnia
9%
Flank pain
9%
Generalized muscle weakness
9%
Genital edema
9%
Hematuria
9%
Memory impairment
9%
Platelet count decreased
9%
Pruritis
9%
Anemia
6%
Sinus disorder
6%
Renal calculi
6%
Confusion
6%
Dyspepsia
6%
Muscle weakness lower limb
6%
Peripheral sensory neuropathy
6%
Renal and urinary disorders - Other
6%
Skin and subcutaneous tissue disorders - Other
6%
Vomiting
6%
Alkaline phosphatase increase
6%
Blood bilirubin increased
6%
Blurred vision
3%
Skin infection
3%
Alopecia
3%
Cystitis noninfective
3%
Fracture
3%
General disorders and administration site conditions - Other
3%
Hypokalemia
3%
Upper respiratory infection
3%
Weight gain
3%
Infections and infestations - Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Enzalutamide)
Treatment (Enzalutamide, Mifepristone)
Not Randomized

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,337 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,924 Previous Clinical Trials
41,017,708 Total Patients Enrolled
Steven Smith, PhDPrincipal InvestigatorCity of Hope Medical Center

Media Library

Transrectal Prostate Biopsy Clinical Trial Eligibility Overview. Trial Name: NCT01441687 — N/A
Healthy Subjects Research Study Groups: Arm I (PMU), Arm II (EPS)
Healthy Subjects Clinical Trial 2023: Transrectal Prostate Biopsy Highlights & Side Effects. Trial Name: NCT01441687 — N/A
Transrectal Prostate Biopsy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01441687 — N/A
~15 spots leftby Nov 2025
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