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

Active, not recruiting

• Conditions: Prostate Adenocarcinoma; Prostate Carcinoma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06347809
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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 Timeline

• Study Start: 2019-01-23
• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-29
• Study First Posted: 2024-04-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-10
• Primary Completion: 2029-02-01
• Study Completion: 2029-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional 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.

Primary Outcome Measures

Name	Time	Method
Accuracy of methylated DNA markers (MDMs) for detection of cancer of the prostate (CAP)	Baseline	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States