Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors

Study Overview
=================
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.

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.

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

Conditions
-----------------
Prostate Cancer, Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Localized Prostate Carcinoma

Intervention / Treatment
-----------------
* Procedure: Focal laser ablation of the prostate


Participation Criteria
=================
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 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.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm study<br>MR guided focal laser ablation of prostate cancer using the Visualase Thermal Therapy System. | Procedure: Focal laser ablation of the prostate<br>* MR guided laser ablation of the focal prostatic lesion which has been identified by MRI and biopsy prior to ablation.<br>* Other names: Visualase Laser Ablation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3 years | 

Secondary Outcome Measures

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