Prostate AdenocarcinomaNCT06347809
DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine
An observational study of Prostate Adenocarcinoma and Prostate Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Adenocarcinoma, Prostate Carcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2019to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- * 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
Who cannot join
- * 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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
- Prostate Adenocarcinoma, Prostate Carcinoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (2)
Accuracy of CAP detection
Assessed by instances of CAP detected and confirmed using MDMs assayed from urine and prostate fluid.
Measured: Baseline
Comparison of sample volumes
Variability of sample volumes will be assessed for DNA and MDM yield.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start23 Jan 2019
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Why it stopped: Closed to consolidate enrollment under another related study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John B. Kisiel, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347809
- Sponsor's protocol ID
- 18-006343
- Other IDs
- NCI-2024-01225, 18-006343
- Status last verified
- Dec 2025
- First submitted
- 15 Mar 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine
- ClinicalTrials.gov ID
- NCT06347809
- Acronym / sponsor ID
- 18-006343
- Conditions
- Prostate Adenocarcinoma, Prostate Carcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Closed to consolidate enrollment under another related study
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPHASE 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- * Patient is 18 years or older
Key exclusion criteria (14 listed)
- * Patient has had a transplant prior to sample collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-Interventional Study | Other | Observational |
Primary outcome
Accuracy of methylated DNA markers (MDMs) for detection of cancer of the prostate (CAP)
Time frame: 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.
2 secondary outcomes
Accuracy of CAP detection
Time frame: Baseline
Comparison of sample volumes
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Closed to consolidate enrollment under another related study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John B. Kisiel, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Adenocarcinoma and Prostate Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Closed to consolidate enrollment under another related study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of methylated DNA markers (MDMs) for detection of cancer of the prostate (CAP) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.