Clinical Trials /

Focal Laser Ablation of Prostate Cancer Tumors

NCT02600156

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Focal Laser Ablation of Prostate Cancer Tumors
  • Official Title: A Pilot Study to Evaluate Magnetic Resonance Thermal Image-Guided Focal Laser Ablation of Prostate Cancer Tumors

Clinical Trial IDs

  • ORG STUDY ID: 14-005500
  • NCT ID: NCT02600156

Conditions

  • Prostate Cancer

Purpose

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.

Detailed 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.
    

Trial Arms

NameTypeDescriptionInterventions
Single arm studyExperimentalMR guided focal laser ablation of prostate cancer using the Visualase Thermal Therapy System.

    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.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:45 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Success rate
    Time Frame:3 years
    Safety Issue:
    Description:To evaluate the procedural success rate of using the MR-guided laser ablation to target, access, thermally monitor, and focally ablate MR-visible prostate cancer lesions.

    Secondary Outcome Measures

    Measure:Short- and mid-term ablative success
    Time Frame:3 years
    Safety Issue:
    Description:To obtain preliminary data on ablative success using longitudinal MR imaging assessment of treated areas.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Mayo Clinic

    Last Updated

    November 27, 2019