Study of Validated Biomarkers in Urine for Patients with Adenocarcinoma of the Prostate


About this study

The purpose of this study is to assess the accuracy of DNA marker candidates (individually and in combination) assayed from urine and prostatic fluid (collected following digital prostate massage) for detection of prostate cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patient has a histology diagnosis of prostatic carcinoma/adenocarcinoma with a Gleason score.
  • Patient has an elevated PSA, palpable prostate nodule, abnormal imaging finding or worrisome PSA velocity where prostate biopsy is planned.
  • Male, age ≥ 18 years old.

Exclusion Criteria:

  • Patients has a history of bladder cancer.
  • Patient has had biopsy (within the last 6 weeks).
  • Patient has had surgery to completely remove current target pathology.
  • The current target pathology is a recurrence.
  • Patient has had a transplant.
  • Patient has received chemotherapy class drugs (e.g. Docetaxal, Methotrexate) or therapeutic radiation.
  • Patient has had anti-androgen (Flutamide, Androcur, Casodex, Nilandron) or LHRH (Lupron, Zoladex) therapy.
  • Patient has transurethral instrumentation (cystoscopy, placement of urinary catheter) within the past week.
  • Patient has chronic indwelling urinary catheter.
  • Patient has prior focal ablation (e.g. HIFU or cryoablation) of prostate cancer.
  • Patient has had a urinary tract infection within 14 days of collection.
  • Patient has ejaculated within 2 days of sample collection.


Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Kisiel, M.D.

Open for enrollment

Contact information:

Grant Dubbels B.S.


More information


Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions