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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month after sample collection

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

82%

Fatigue

45%

Hot flashes

42%

Anorexia

39%

Constipation

27%

Pain

27%

Generalized muscle weakness

21%

Back pain

18%

Diarrhea

18%

Headache

18%

Hypertension

18%

Dizziness

18%

Nausea

15%

Weight loss

15%

Arthralgia

15%

Upper respiratory infection

12%

Abdominal pain

12%

Memory impairment

12%

Peripheral sensory neuropathy

12%

Hematuria

12%

Vomiting

12%

Fall

12%

Pain in extremity

12%

Urinary frequency

Dyspnea

Pelvic pain

Hyperglycemia

General disorders and administration site conditions - Other

Anxiety

Edema limbs

Breast pain

Alopecia

Ear pain

Flank pain

Urinary incontinence

White blood cell decreased

Renal and urinary disorders - Other

Investigations - Other

Cystitis noninfective

Fracture

Hypokalemia

Weight gain

Watering eyes

Paresthesia

Neoplasms benign, malignant and unspecified

Flu like symptoms

Arthritis

Bone pain

Cough

Urinary retention

Neutrophil count decreased

Small intestinal obstruction

Depression

Dyspepsia

Platelet count decreased

Confusion

Ileus

Skin and subcutaneous tissue disorders - Other

Skin infection

Non-cardiac chest pain

Blurred vision

Muscle weakness lower limb

Insomnia

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Enzalutamide, Mifepristone)

Treatment (Enzalutamide)

Not Randomized

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,217 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,910 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locales are managing this research endeavor?

"This trial is currently enrolling patients at 10 different medical sites, including Chinn & Chinn Urology Associates, Inc. in Arcadia and City of Hope Medical Center/City of Hope- South Pasadena Cancer Center both located in California."

Answered by AI

Are there any unoccupied spots available in this trial for participants?

"This research endeavour is not currently seeking participants, as indicated by clinicaltrials.gov data which records the study's first posting on July 14th 2009 and last update occurring on March 17th 2022. However, there are 2159 other trials actively searching for contenders at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2009. "Comparing the Reliability of Expressed Prostatic Secretion (EPS) and Post Massage Urine (PMU) for the Prediction of Prostate Cancer Biopsy Outcome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01441687.

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