A Study of MRI-Targeted Biopsy Compared to Standard Ultrasound Guided Biopsy for the Diagnosis of Prostate Cancer

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes 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.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 15-008810
    NCT ID: NCT02380027
    Sponsor Protocol Number: DRF-2014-07-146

About this study

The purpose of this study is to evaluate the detection rates of MRI-targeted prostate biopsies compared to standard 12-core trans-rectal ultrasound guided (TRUS) prostate biopsies for 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy
  • Serum PSA ≤ 20ng/ml within the previous 3 months
  • Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months
  • Fit to undergo all procedures listed in protocol
  • Able to provide written informed consent

Exclusion Criteria

  • Prior prostate biopsy
  • Prior treatment for prostate cancer
  • Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min)
  • Contraindication to prostate biopsy
  • Men in whom artifact would reduce the quality of the MRI
    • Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
  • Unfit to undergo any procedures listed in protocol

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Lance Mynderse, M.D.

Closed for enrollment

Contact information:

Jane Smith R.N.

(507)266-5835

smith.jane2@mayo.edu

.
CLS-20202719

Mayo Clinic Footer