Prostate Adenocarcinoma, Prostate Carcinoma
Conditions
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.
Interventions
OTHERNon-Interventional Study
Non-Interventional Study
Sponsors
Mayo Clinic
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of methylated DNA markers (MDMs) for detection of cancer of the prostate (CAP) | 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
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of CAP detection | Baseline | Assessed by instances of CAP detected and confirmed using MDMs assayed from urine and prostate fluid. |
| Comparison of sample volumes | Baseline | Variability of sample volumes will be assessed for DNA and MDM yield. |
Countries
United States
Outcome results
None listed