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Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT02600156
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
87
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Focal laser ablation of the prostate
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study to Evaluate Magnetic Resonance Thermal Image-Guided Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors
Study Start Date :
Sep 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single arm study

MR guided focal laser ablation of prostate cancer using the Visualase Thermal Therapy System.

Procedure: Focal laser ablation of the prostate
MR guided laser ablation of the focal prostatic lesion which has been identified by MRI and biopsy prior to ablation.
Other Names:
  • Visualase Laser Ablation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Success rate [3 years]

      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.

    2. Incidence of treatment emergent adverse events [3 years]

      To evaluate patient-related safety by monitoring short and long-term complications related to the procedure such as but not limited to incontinence, impotence, and urethral fistulas.

    Secondary Outcome Measures

    1. Short- and mid-term ablative success [3 years]

      To obtain preliminary data on ablative success using longitudinal MR imaging assessment of treated areas.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Minnesota Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: David Woodrum, MD, PhD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    David A. Woodrum, David A. Woodrum, M.D., Ph.D., Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02600156
    Other Study ID Numbers:
    • 14-005500
    First Posted:
    Nov 9, 2015
    Last Update Posted:
    May 6, 2022
    Last Verified:
    May 1, 2022
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of May 6, 2022