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

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

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.

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