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

NCT03998657 | Active Not Recruiting FDA Device

• 1 other identifier: PCa003CA
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Exablate Treated Arm

EXPERIMENTAL

Treatment with Exablate Prostate 2100 Type-3 System

Device: Exablate Prostate Treatment

Interventions

Exablate Prostate Treatment 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.

Also known as: Exablate Prostate, Exablate MRgFUS

Exablate Treated Arm

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Males only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InSightec: lead

Study Sites (5)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Sperling Prostate Center

Delray Beach, Florida, 33445, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 26, 2019
• Study Start: December 19, 2019
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)