EPS vs PMU Biomarkers for Predicting Prostate Cancer Biopsy Outcomes

Not currently recruiting at 4 trial locations

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Previous prostate cancer, Recent cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 month

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to predict prostate cancer biopsy results using two different urine-based tests. Researchers aim to determine whether expressed prostatic secretion (EPS) or post-massage urine (PMU) biomarkers offer better insights into potential prostate cancer. Participants will undergo a transrectal prostate biopsy and provide samples either by giving urine after a prostate massage or following a digital rectal exam. The trial seeks men scheduled for a prostate biopsy due to concerns about prostate cancer. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance prostate cancer diagnosis methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these biomarkers are safe for predicting prostate biopsy outcomes?

Research has shown that both PMU (post massage urine) and EPS (expressed prostatic secretions) are generally safe for detecting prostate cancer.

For PMU, studies have explored urine tests as a less invasive alternative to biopsies, showing promise in early cancer detection. The process mainly involves collecting urine after a special massage, resulting in minimal side effects.

EPS involves collecting prostate fluid after a digital rectal exam, which can help identify signs of cancer. This common urological procedure is considered safe, with no major reports of problems.

Overall, both PMU and EPS collection are well-tolerated and do not present significant safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new methods for predicting prostate cancer biopsy outcomes using biomarkers from urine and expressed prostatic secretions (EPS). Unlike the standard prostate biopsy, which is primarily guided by imaging and PSA levels, this trial investigates whether analyzing PMU (post-massage urine) and EPS can offer more accurate predictions. This could potentially lead to less invasive, more precise diagnostic techniques, reducing unnecessary biopsies and improving patient care.

What evidence suggests that EPS or PMU biomarkers are effective for predicting prostate biopsy outcomes?

This trial will compare PMU and EPS tests for predicting prostate cancer biopsy outcomes. Research has shown that both PMU and EPS tests can help predict prostate cancer outcomes. Participants in Arm I will undergo PMU analysis. A new urine test, similar to PMU, correctly identified prostate cancer in 91% of cases and correctly ruled out non-cancer cases 84% of the time, suggesting PMU tests could reliably detect prostate cancer. Participants in Arm II will undergo EPS, which involves collecting fluid from the prostate after a gentle massage. Research indicates that EPS can help determine the cancer's aggressiveness. Both methods aim to improve the accuracy of prostate cancer diagnosis before a biopsy is needed. ^{1 6 7 8 9}

Who Is on the Research Team?

Steven Smith, PhD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either PMU or EPS analysis followed by a prostate biopsy

1 month

1 visit (in-person)

Follow-up

Participants are monitored for assay results and biopsy outcomes

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Laboratory Biomarker Analysis
• Transrectal Prostate Biopsy

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm II (EPS) Experimental Treatment 2 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 Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2720443/

Clinical Collection and Protein Properties of Expressed ... The prostate gland secretes many proteins in a prostatic fluid that combines with seminal vesicle derived fluids to promote sperm activation and function.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4106656/

Risk stratification of prostate cancer patients based on EPS ... The expressed prostate secretion fluids were obtained following gentle prostate massage during digital rectal examination prior to biopsy. The massage ...

3. canjurol.com canjurol.com/html/subscriber/Spdf/V20I01//V20I1_03_DrWhelan.pdf

The influence of PSA-RNA yield on the analysis of ... Eighty-six men who were undergoing prostate biopsy for evaluation of prostate cancer gave consent for EPS specimen collection under an Institutional Review.

4. pubs.acs.org pubs.acs.org/doi/10.1021/acsomega.2c05487

A Predictive Model for Prostate Cancer | ACS Omega In this work, expressed prostatic secretion (EPS)-urine samples from PCa patients and benign prostatic hyperplasia (BPH) patients were analyzed with the aim ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1874391909000037

Clinical collection and protein properties of expressed ... EPS represents the fluid being secreted by the prostate following a digital rectal prostate massage, which in turn can be collected in voided ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3518113/

Identification of Differentially Expressed Proteins in Direct ... Fluids that are proximal to the prostate, such as expressed prostatic secretions (EPS), are attractive sources of potential prostate cancer biomarkers as these ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2287888223000594

Infectious complications of transrectal prostate biopsy in ... The aim of our study was to investigate the role of TAP after rectal and urethral swab cultures compared to EAP for the prevention of infectious complications ...

8. mdpi.com mdpi.com/1422-0067/22/24/13605

Extracellular Vesicle Proteome in Prostate Cancer The seminal glands open into the prostatic urethra at its proximal side allowing collection of expressed-prostatic secretion fluids. Nevertheless, clinical ...

9. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0066630

Expressed Prostate Secretions in the Study of Human ... Expressed prostate secretions (EPS) are obtained during digital rectal examination (DRE), a daily routine urological diagnostic procedure, following massage of ...