DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine
NCT ID: NCT06347809
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
24 participants
OBSERVATIONAL
2019-01-23
2025-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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.
Non-Interventional Study
Non-Interventional Study
Interventions
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Non-Interventional Study
Non-Interventional Study
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
MALE
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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John B. Kisiel, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2024-01225
Identifier Type: REGISTRY
Identifier Source: secondary_id
18-006343
Identifier Type: OTHER
Identifier Source: secondary_id
18-006343
Identifier Type: -
Identifier Source: org_study_id
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