MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This phase II trial studies how well magnetic resonance (MR)-guided laser interstitial thermal therapy works in treating patients with prostate cancer. Laser therapy uses intense, narrow beams of light to cut and destroy tissue and may help treat prostate cancer

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To evaluate the oncologic efficacy of laster interstitial thermal therapy (LITT) with primary endpoint of undetectable cancer on magnetic resonance imaging (MRI)-guided biopsy of treatment zone at 3 months following treatment. SECONDARY OBJECTIVES: I. To evaluate oncologic efficacy at 12 months following treatment based on biopsy of the treatment zone. II. To determine treatment-related safety and toxicity. III. To longitudinally assess urinary and sexual function in the year following treatment. OUTLINE: Patients undergo MR-guided LITT. After completion of study treatment, patients are followed up at 1, 3, and 12 months.

Official Title
-----------------
Phase II Evaluation of MR-Guided Laser Induced Interstitial Thermal Therapy (LITT) for Prostate Cancer

Conditions
-----------------
Stage I Prostate Cancer, Stage II Prostate Carcinoma

Intervention / Treatment
-----------------
* Device: Visualase Thermal Therapy
* Procedure: magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical characteristics: Stage T1c or T2a Prostate-specific antigen (PSA) < 15 ng/ml or PSA density (PSA divided by prostate volume in cubic centimeters) < 0.15 ng/ml^3 No evidence of metastatic disease based on National Comprehensive Cancer Network (NCCN) guidelines: Bone scan if PSA > 20 ng/ml and clinical stage T1c Bone scan if PSA > 10 ng/ml and clinical stage T2 Biopsy requirements: Gleason score 7 or less 25% or fewer biopsies with cancer At least 12 biopsy cores of the prostate Within 12 months of treatment Imaging requirements: Up to 2 visible magnetic resonance (MR) lesion(s) concordant with sextant of biopsy-detected cancer(s) MRI within 6 months of treatment Karnofsky performance status of at least 70 General health is suitable to undergo the planned minimally invasive procedures Risks, benefits, and alternatives discussed with informed consent given Exclusion Criteria: Previous treatment of prostate cancer with luteinizing hormone releasing hormone (LHRH) agonist/antagonist, chemotherapy, surgery, or radiation Presence of 3 or more visible lesions on MRI High suspicion of seminal vesicle invasion or lymph node metastases on MRI Unable to tolerate MRI (medical device, foreign body, claustrophobia, body habitus, or other) Renal insufficiency with estimated glomerular filtration rate (eGFR) < 30 ml/min/body surface area (BSA) based on Modification in Diet Renal Disease equation; inability to safely receive gadolinium contrast for MRI History of prior pelvic surgery with surgical clips remaining in situ (e.g., bladder, bowel, internal pelvic organs) that compromise MRI image quality Other serious illnesses involving the cardiac, respiratory, central nervous system (CNS), or hepatic organ systems, which would preclude study completion or impede the determination of causality of any complications experienced during the conduct of this study

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: Treatment (LITT)<br>Patients undergo Magnetic Resonance imaging (MR) guided laser thermal therapy with Visualase Thermal Therapy device. | Device: Visualase Thermal Therapy<br>* MR guided laser ablation of prostate cancer<br>* Other names: laser interstitial thermal therapy;Procedure: magnetic resonance imaging<br>* Undergo MR-guided LITT<br>* Other names: nuclear magnetic resonance imaging;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment | The primary study end point was the number of patients with no cancer on MRI guided biopsy of the ablation zone at 3 months. | At 3 months after ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Patients With Biopsy Cancer of the Treatment Zone | A systematic 12-core biopsy was performed at 1 year and the number of patients with biopsy cancer was counted. | At 12 months | 
| The Total Number of Patients With Any Adverse Events Related to the Treatment | Treatment-related toxicity measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | 1,3, and 12 month after treatment and up to 12 months | 
| Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS) | International Prostate Symptom Score (IPSS) measures urinary symptoms and continence and it ranged 0 to 35. Lower values are considered better outcome. | At 1,3 and 12 months | 
| Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM) | Sexual Health Inventory Score in Men (SHIM) measures sexual health and erectile function and it ranged 1 to 25. Lower values are considered better outcome. | At 1,3 and 12 months |