Study of Validated Biomarkers in Urine for Patients with Adenocarcinoma of the Prostate
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-006343
Sponsor Protocol Number: 18-006343
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.
(507)538-6151
Dubbels.Grant@mayo.edu
|
More information
Publications
Publications are currently not available