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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03998657
• Other study ID #: PCa003CA
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 19, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2022
• Source: InSightec
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Sperling Prostate Center	Delray Beach	Florida
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
InSightec

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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