DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine

This study explores the potential use of DNA markers in the detection of prostate cancer and patient perceptions of this screening approach and other current or future prostate cancer screening and diagnostic tests.

Study Overview

• Status: Terminated
• Conditions: Prostate Adenocarcinoma; Prostate Carcinoma
• Intervention / Treatment: Other: Non-Interventional Study

Detailed Description

PRIMARY OBJECTIVE:

I. To assess the accuracy of MDM candidates (individually and in combination) assayed from urine and prostatic fluid (collected following digital prostate massage) for detection of CAP.

OUTLINE: This is an observational study.

PHASE I: Participants undergo urine sample collection on study.

PHASE II: Participants undergo standard prostate massage and collection of prostatic fluid and urine samples on study.

All participants complete a questionnaire and have their medical records reviewed on study.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patient with diagnosis of prostate carcinoma/adenocarcinoma with a corresponding Gleason score OR is scheduled for a prostate biopsy for an elevated PSA, palpable prostate nodule, an abnormal imaging finding, or worrisome PSA velocity.

Description

Inclusion Criteria:

• * Patient is 18 years or older

  • Patient has a histologically confirmed diagnosis of prostatic carcinoma/adenocarcinoma with a corresponding Gleason score OR is scheduled for a prostate biopsy for an elevated Prostate Specific Antigen (PSA), palpable prostate nodule, an abnormal imaging finding, or worrisome PSA velocity

Exclusion Criteria:

• * Patient has had a transplant prior to sample collection

  • Patient has had Androgen (e.g. Flutamide, Androcur, Casodex, Nilandron) or Luteinizing hormone-releasing hormone (LHRH) (e.g. Lupron, Zoladex) therapy
  • Patient has transurethral instrumentation (cystoscopy, placement of urinary catheter) within the 7 days prior to sample collection
  • Patient has chronic indwelling urinary catheter
  • Patient has had a urinary tract infection within the 14 days prior to sample collection
  • Patient has immunotherapy (e.g. Kwon study drugs) for prostate cancer prior to sample collection
  • Patient has a history of bladder cancer
  • Patient has had a biopsy within the last 6 weeks (excluding non-melanoma skin biopsies) of sample collection
  • Patient has had surgery to completely remove current target pathology prior to sample collection
  • Patient has a prior history of prostate carcinoma/adenocarcinoma
  • Patient has received chemotherapy class drugs (e.g. Docetaxel, Methotrexate) within the 5 years prior to sample collection
  • Patient has received therapeutic radiation prior to sample collection
  • Patient has had focal ablation [e.g. High-intensity focused ultrasound (HIFU) or cryoablation] of prostate cancer prior to sample collection
  • Patient has known primary cancer outside of the prostate within the last 5 years (not including basal cell or squamous cell skin cancers) of sample collection

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; PHASE I: Participants undergo urine sample collection on study. PHASE II: Participants undergo standard prostate massage and collection of prostatic fluid and urine samples on study. All participants complete a questionnaire and have their medical records reviewed on study.	Other: Non-Interventional Study; Non-Interventional Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of methylated DNA markers (MDMs) for detection of cancer of the prostate (CAP)	Assessed by instances of CAP detected using MDMs assayed from urine (Phase I) and from urine and prostate fluid (collected following digital prostate massage for participants in Phase II) for detection of CAP.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of CAP detection	Assessed by instances of CAP detected and confirmed using MDMs assayed from urine and prostate fluid.	Baseline
Comparison of sample volumes	Variability of sample volumes will be assessed for DNA and MDM yield.	Baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: John B. Kisiel, M.D., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2019
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 18-006343 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2024-01225 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No