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

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Device: Exablate Prostate Treatment

• Registration Number: NCT03998657
• Lead Sponsor: InSightec

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-17
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-26
• Study Start: 2019-12-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exablate Treated Arm	Exablate Prostate Treatment	Treatment with Exablate Prostate 2100 Type-3 System

Primary Outcome Measures

Name	Time	Method
Incidence and severity of device/procedure-related complications following treatment	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.	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.

Trial Locations

Locations (5)

Sperling Prostate Center; 🇺🇸 Delray Beach, Florida, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States