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Completed

NCT Number: NCT02600156

Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Localized Prostate Carcinoma Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Adenocarcinoma Prostatic Diseases Prostatic Neoplasms Stage I Prostate Cancer AJCC v8 Stage II Prostate Cancer AJCC v8 Urogenital Diseases Urogenital Neoplasms

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Minnesota

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Focal laser ablation of the prostate

Procedure

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

Primary outcomes

  1. Success rate

    Time frame: 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

    Time frame: 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 outcomes

  1. Short- and mid-term ablative success

    Time frame: 3 years

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Pilot Study to Evaluate Magnetic Resonance Thermal Image-Guided Focal Laser Ablation of Prostate Cancer Tumors

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Nov 9, 2015
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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