Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors

Mayo Clinic7 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer Prostate Adenocarcinoma Stage I Prostate Cancer AJCC v8 Stage II Prostate Cancer AJCC v8 Localized Prostate Carcinoma

Interventions

Focal laser ablation of the prostatePROCEDURE

MR guided laser ablation of the focal prostatic lesion which has been identified by MRI and biopsy prior to ablation.

Eligibility

Sex: MALEMin age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic in Minnesota

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Success rate

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.

Time frame: 3 years

Incidence of treatment emergent adverse events

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.

Time frame: 3 years

Secondary Outcomes

Short- and mid-term ablative success

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

Time frame: 3 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.