Focal Laser Ablation of Prostate Cancer Tumors

Overview

  • Study type

    Interventional
  • 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.
  • Site IRB
    • Rochester, Minnesota: 14-005500
    NCT ID: NCT02600156
    Sponsor Protocol Number: 14-005500

About this study

The primary purpose of this study is to evaluate the feasibility and safety of MRI-guided focal laser ablation (Laser-Induced Interstitial Thermal Therapy, LITT) to treat low-risk native 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

  • Male, 45 years of age or older.
  • Diagnosis of prostate adenocarcinoma.
  • Clinical stage T1c or T2a.
  • Gleason score of 7 (3+4 or 4+3) or less.
  • Three or fewer biopsy cores with prostate cancer.
  • No single biopsy core with greater than 50% of tumor involvement.
  • One, two, or three tumor suspicious regions identified on multiparametric MRI
  • Negative radiographic indication of extra-capsular extent.
  • A documented Karnofsky performance status of at least 70.
  • Estimated survival of 5 years or greater, as determined by treating physician.
  • Tolerance for anesthesia/sedation.
  • Ability to give informed consent.
  • MR-guided biopsy confirmation of one or more radiographically visible prostate lesion(s) with Gleason score of 7 (3+4 or 4+3) or less.

Exclusion Criteria

  • Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
  • History of other primary non-skin malignancy within previous three years.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

David Woodrum, M.D., Ph.D.

Open for enrollment

Contact information:

Connie Sathre CCRP

(507)538-0540

rstinterventionaloncology@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20167647

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