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

Primary Purpose

Prostate Cancer

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exablate Prostate Treatment

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Stanford University School of Medicine
Sperling Prostate Center
Brigham & Women's Hospital
Mayo Clinic
Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exablate Treated Arm

Arm Description

Treatment with Exablate Prostate 2100 Type-3 System

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03998657

First Posted

June 17, 2019

Last Updated

May 23, 2022

Sponsor

InSightec

1. Study Identification

Unique Protocol Identification Number

NCT03998657

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 19, 2019 (Actual)

Primary Completion Date

December 30, 2022 (Anticipated)

Study Completion Date

December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InSightec

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exablate Treated Arm

Arm Type

Experimental

Arm Description

Treatment with Exablate Prostate 2100 Type-3 System

Intervention Type

Device

Intervention Name(s)

Exablate Prostate Treatment

Other Intervention Name(s)

Exablate Prostate, Exablate MRgFUS

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence and severity of device/procedure-related complications following treatment

Description

Time Frame

12 months

Title

Proportions of treated subjects reporting negative Gleason 7 biopsy within the prostate biopsy treatment area.

Description

Time Frame

6 months

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Males only

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Sperling Prostate Center

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33445

Country

United States

Facility Name

Brigham & Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Memorial Sloan-Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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