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

NCT06347809 | Terminated

• 2 other identifiers: 18-006343NCI-2024-01225
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Adenocarcinoma; Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Accuracy of CAP detection

  Baseline

• Comparison of sample volumes

  Baseline

Study Arms (1)

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

Interventions

Non-Interventional Study OTHER

Non-Interventional Study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \* 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

You may not qualify if:

• \* 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Participants can choose whether they permit their urine samples to be stored and used in future cancer research at Mayo Clinic.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• John B. Kisiel, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: April 4, 2024
• Study Start: January 23, 2019
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1)