Continued Access of Focal MR-Guided Focused Ultrasound for Localized Intermediate Risk Prostate Lesions

Study Overview
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Brief Summary
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This extended clinical investigation is a multicenter, prospective, single arm study intended to provide continued access of the Exablate Model 2100 device (Exablate Prostate) to patients for treatment of prostate lesions and collect additional safety and effectiveness data during the 510(k) preparation and review period.

Official Title
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A Continued Access Study to Evaluate Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Exablate Prostate Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy proven adenocarcinoma of the prostate Intermediate risk, organ-confined prostate cancer (T1a up to T2b) and voluntarily chooses Exablate, who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy Up to 2 MRI visible Gleason 7 confirmed on mapping prostate biopsy that Investigator deems treatable within a single treatment session; may have secondary Gleason 6 on ipsilateral or contralateral side confirmed with biopsy and/or MRI PSA less than or equal to 20ng/mL Exclusion Criteria: Evidence of distant prostate cancer including lymph node involvement and/or metastasis of cancer Subject undergoing androgen deprivation therapy, initiating any new medication that can affect PSA, or history of bilateral orchiectomy Active bladder cancer, active UTI, or untreated prostatitis Untreated urethral stricture/bladder neck contracture Prostate-specific chemotherapy, brachytherapy, cryotherapy, photodynamic therapy, radical prostatectomy, or focal therapy (excluding FUS); or any prior radiation therapy to the pelvis for prostate cancer or any other malignancy Subjects with pathology or implants that may adversely impact treatment due to acoustics, imaging, or safe probe insertion Subject not able or willing to tolerate the required prolonged stationary supine position during treatment Contraindications to MRI

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exablate Treated Arm<br>Treatment with Exablate Prostate 2100 Type-3 System | Device: Exablate Prostate Treatment<br>* The Exablate system is a non-invasive thermal ablation device that is being used to ablate tissue. The system combines a focused ultrasound surgery (FUS) delivery system and MRI scanner.<br>* Other names: Exablate MRgFUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of device/procedure-related complications following treatment | Safety will be evaluated by incidence and severity of device/procedure-related complications following treatment. Adverse events will be recorded and categorized according to severity and relationship to the biopsy procedure, the Exablate procedure, or to the Exablate device. They will be classified based on body system, severity, and frequency. | 12 months | 
| Proportions of treated subjects reporting negative Gleason 7 biopsy within the prostate biopsy treatment area. | Effectiveness will be evaluated by targeted lesion control based on biopsy results. Proportions of treated subjects reporting negative Gleason 7 biopsy within the treatment area and/or MRI verification of index lesion(s) ablation. PSA results and validated subject-reported questionnaires will be summarized. | 6 months |