EPS vs PMU Biomarkers for Predicting Prostate Cancer Biopsy Outcomes

Recruiting at 4 trial locations

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: City of Hope Medical Center

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

Compensation: Varies

Number of Visits: 1

Duration: 1 month

243 Participants Needed

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

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 data supports the effectiveness of the treatment involving Laboratory Biomarker Analysis, Imbruvica, and Transrectal Prostate Biopsy for predicting prostate cancer biopsy outcomes?

The research highlights the use of various biomarkers and scoring systems, like the 4Kscore test, which have been shown to predict prostate cancer effectively. These methods help in deciding when a prostate biopsy is necessary, potentially improving the accuracy of prostate cancer detection. ^{1 2 3 4 5}

Is the transrectal prostate biopsy generally safe for humans?

The short-term outcomes of transrectal prostate biopsy show that some men may experience adverse events (unwanted effects) within 35 days after the procedure, but these are typically manageable and healthcare resources are used to address them. ^{6 7 8 9 10}

How is the transrectal prostate biopsy treatment different from other prostate cancer treatments?

Transrectal prostate biopsy is unique because it involves using an ultrasound probe inserted into the rectum to guide the biopsy needle directly to the prostate, allowing for precise sampling of prostate tissue. This method is primarily diagnostic, helping to determine the presence of cancer, rather than treating the cancer itself, which distinguishes it from other treatments like surgery or radiation therapy that aim to remove or destroy cancer cells. ^{1 2 4 11 12}

Research Team

Steven Smith, PhD

Principal Investigator

City of Hope Medical Center

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Monofocal and plurifocal high-grade prostatic intraepithelial neoplasia on extended prostate biopsies: factors predicting cancer detection on extended repeat biopsy. [2016]

2. China pubmed.ncbi.nlm.nih.gov

[Establishment of a scoring system for predicting the positive rate of prostatic biopsy for prostate cancer]. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

A 4Kscore Cut-off of 7.5% for Prostate Biopsy Decisions Provides High Sensitivity and Negative Predictive Value for Significant Prostate Cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Utility of Prostate Specific Antigen Density, Prostate Health Index, and Prostate Health Index Density in Predicting Positive Prostate Biopsy Outcome is Dependent on the Prostate Biopsy Methods. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Predictors of prostate cancer after initial diagnosis of atypical small acinar proliferation at 10 to 12 core biopsies. [2005]

6. England pubmed.ncbi.nlm.nih.gov

What is the risk of prostate cancer mortality following negative systematic TRUS-guided biopsies? A systematic review. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Short term outcomes of prostate biopsy in men tested for cancer by prostate specific antigen: prospective evaluation within ProtecT study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Predictors of prostate cancer after initial negative systematic 12 core biopsy. [2004]

9. United States pubmed.ncbi.nlm.nih.gov

Optimal sampling scheme in men with abnormal multiparametric MRI undergoing MRI-TRUS fusion prostate biopsy. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Transition Zone Prostate-specific Antigen Density Could Better Guide the Rebiopsy Strategy in Men With Prostate Inflammation at Initial Biopsy. [2016]

11. Netherlands pubmed.ncbi.nlm.nih.gov

The 4Kscore Predicts the Grade and Stage of Prostate Cancer in the Radical Prostatectomy Specimen: Results from a Multi-institutional Prospective Trial. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

A 17-gene Panel for Prediction of Adverse Prostate Cancer Pathologic Features: Prospective Clinical Validation and Utility. [2019]