DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine

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