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

NCT ID: NCT03998657

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-19
• Study Completion Date: 2026-12-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exablate Treated Arm

Treatment with Exablate Prostate 2100 Type-3 System

Group Type: EXPERIMENTAL

Exablate Prostate Treatment

Intervention Type: DEVICE

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.

Interventions

Exablate Prostate Treatment

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.

Intervention Type: DEVICE

Other Intervention Names

Exablate Prostate; Exablate MRgFUS

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

InSightec

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stanford University School of Medicine

Stanford, California, United States

Sperling Prostate Center

Delray Beach, Florida, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

PCa003CA

Identifier Type: -

Identifier Source: org_study_id