A Continued Access Study to Evaluate Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- InSightec
- Enrollment
- 14
- Locations
- 5
- Primary Endpoint
- Incidence and severity of device/procedure-related complications following treatment
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Exablate Treated Arm
Treatment with Exablate Prostate 2100 Type-3 System
Intervention: Exablate Prostate Treatment (Device)
Outcomes
Primary Outcomes
Incidence and severity of device/procedure-related complications following treatment
Time Frame: 12 months
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.
Proportions of treated subjects reporting negative Gleason 7 biopsy within the prostate biopsy treatment area.
Time Frame: 6 months
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.
Secondary Outcomes
No secondary outcomes reported