Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors

Last updated: April 22, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Prostate Cancer, Early, Recurrent

Prostate Cancer

Urologic Cancer

Treatment

Focal laser ablation of the prostate

Clinical Study ID

NCT02600156
14-005500
  • Ages > 45
  • Male

Study Summary

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.

Eligibility Criteria

Inclusion

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 Intermediate risk Gleason 6

  • PSA less than or equal to 20 ng/mL

  • Three or fewer biopsy locations with prostate cancer which correlate with MRI findings.

  • No lesion > or = 2cm

  • One, two, or three tumor suspicious regions identified on multiparametric MRI

  • No definite radiographic indication of extra-capsular extension.

  • Estimated survival of 5 years or greater, as determined by treating physician.

  • Tolerance for anesthesia/sedation.

  • Ability to give informed consent.

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.

Study Design

Total Participants: 7
Treatment Group(s): 1
Primary Treatment: Focal laser ablation of the prostate
Phase:
Study Start date:
September 01, 2015
Estimated Completion Date:
December 31, 2026

Study Description

The study is being done to evaluate the safety and effectiveness of Magnetic Resonance Imaging (MRI)-guided focal laser therapy with the Visualase Thermal Therapy System to treat low-risk prostate cancer tumors. Unlike surgery or radiotherapy which affects a large portion of the prostate or the entire organ, localized or focal therapy is intended to treat a small portion of tissue in which the cancer has been found by biopsy.

Connect with a study center

  • Mayo Clinic in Minnesota

    Rochester, Minnesota 55905
    United States

    Site Not Available

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