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DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine | Clinical Trials | Clareo Health

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

NCT06347809•Mayo Clinic

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Yes

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
+4 more criteria

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

January 23, 2019

Primary Completion Date

July 31, 2025

Completion Date

July 31, 2025

Last Updated

December 15, 2025

Enrollment

ACTUAL participants

Conditions

Prostate AdenocarcinomaProstate Carcinoma

Interventions

Non-Interventional Study

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer

Comparing a New PSMA Imaging Agent to MRI for Detecting Prostate Cancer, BEACON Trial

Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer

Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer