DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Adenocarcinoma
- Sponsor
- Mayo Clinic
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Accuracy of methylated DNA markers (MDMs) for detection of cancer of the prostate (CAP)
- Status
- Terminated
- Last Updated
- 4 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Accuracy of CAP detection(Baseline)
- Comparison of sample volumes(Baseline)