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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03998657
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
InSightec

Brief Summary:
This extended clinical investigation is a multicenter, prospective, sing arm study intended to provide continued access of the Exablate(R) 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Exablate Prostate Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Continued Access Study to Evaluate Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions
Actual Study Start Date : December 19, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exablate Treated Arm
Treatment with Exablate Prostate 2100 Type-3 System
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.
Other Names:
  • Exablate Prostate
  • Exablate MRgFUS




Primary Outcome Measures :
  1. Incidence and severity of device/procedure-related complications following treatment [ Time Frame: 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.

  2. Proportions of treated subjects reporting negative Gleason 7 biopsy within the prostate biopsy treatment area. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males only
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998657


Locations
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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Ned Realiza    650-498-8496    nrealiza@stanford.edu   
Principal Investigator: Geoffrey Sonn, MD         
United States, Florida
Sperling Prostate Center Recruiting
Delray Beach, Florida, United States, 33445
Contact: Lillian Blanchard    561-300-1353    lillianb@sperlingmedical.com   
Principal Investigator: Dan Sperling, MD         
United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Rebecca Ramjug    845-857-8714    rramjug@bwh.harvard.edu   
Principal Investigator: Clare Tempany, M.D.         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jennifer Murphy    507-538-0540    murphy.jennifer@mayo.edu   
Principal Investigator: David Woodrum, MD         
Principal Investigator: Lance Mynderse, MD         
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Rachel Tatge    646-227-2257    tatger@mskcc.org   
Principal Investigator: Behfar Ehdaie, MD         
Sponsors and Collaborators
InSightec
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Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT03998657    
Other Study ID Numbers: PCa003CA
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases