Clinical Trials /

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

NCT03998657

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: PCa003CA
  • NCT ID: NCT03998657

Conditions

  • Prostate Cancer

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Exablate Treated ArmExperimentalTreatment with Exablate Prostate 2100 Type-3 System

    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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:50 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Incidence and severity of device/procedure-related complications following treatment
    Time Frame:12 months
    Safety Issue:
    Description: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.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:InSightec

    Last Updated

    January 23, 2020