Clinical trial NCT06347809: DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine
Official title: DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Adenocarcinoma
Prostate Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of methylated DNA markers (MDMs) for detection of cancer of the prostate (CAP)
timeFrame: Baseline
Secondary outcomes:
measure: Accuracy of CAP detection
timeFrame: Baseline
measure: Comparison of sample volumes
timeFrame: Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: John B. Kisiel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: