Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions

September 4, 2020 updated by: InSightec
The hypothesis of this study is that focal treatment with ExAblate MRgFUS has the potential to be an effective non-invasive treatment for intermediate risk, organ-confined prostate lesions, with a low incidence of morbidity. The study hypothesis will be tested by measuring treatment-related safety and initial effectiveness parameters in the ExAblate MRgFUS treated patients, as described above.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Objective of this pivotal trial is to assess safety and initial effectiveness of ExAblate MRgFUS in the treatment of intermediate risk, localized (organ confined) prostate lesions.

ExAblate treatment will be implemented as a focal lesion-selective therapy, directed at pre-defined volume(s)/sector(s) in the prostate, identified by mapping biopsy and multi-parametric MRI, rather than a whole gland or hemi-ablation treatment.

Safety: evaluate incidence and severity of adverse events associated with ExAblate's MRgFUS focal treatment of intermediate risk organ confined prostate lesions. The risk of ExAblate treatment-related incontinence and impotence will also be assessed in this study.

Effectiveness: determine the lesion control effect of ExAblate's MRgFUS focal treatment of intermediate risk organ-confined prostate lesions (confirmed by IMAGE-guided mapping biopsy results).

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine
    • Florida
      • Delray Beach, Florida, United States, 33445
        • Sperling Prostate Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10021
        • Weill Cornell Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria

  • Biopsy proven adenocarcinoma of the prostate (using a IMAGE-guided 14+ core mapping biopsy), and targeted cores as needed obtained up to 6 months prior to scheduled treatment
  • Patient with intermediate risk, early-stage organ-confined prostate cancer (T1a up to T2b, N0, M0) and voluntarily chooses ExAblate thermal ablation as the non-invasive treatment, who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy.
  • Patient with PSA less than or equal to 20 ng/mL
  • Gleason score 7 (4 + 3 or 3 + 4), based on mapping prostate biopsy, with no more than 15mm cancer in maximal linear dimension in any single core
  • Single hemilateral index Gleason 7 lesion, identified in the prostate based on biopsy mapping with supporting MRI; may have secondary Gleason 6 lesion on ipsilateral or contralateral side confirmed with biopsy and/or MRI

Exclusion Criteria

  • Contraindications to MRI
  • History of orchiectomy, PCa-specific chemotherapy, brachytherapy, cryotherapy, Photodynamic therapy or radical prostatectomy for treatment of prostate cancer; any prior radiation therapy to the pelvis for prostate cancer or any other malignancy
  • Patient under medications that can affect PSA for the last 3 months prior to MRgFUS treatment (Androgen Deprivation Treatment; alpha reductase inhibitors)
  • Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (approximately 3 hrs. sonication time)
  • Any rectal pathology, anomaly or previous treatment, which could change acoustic properties of rectal wall or prevent safe probe insertion (e.g., stenosis, fibrosis, inflammatory bowel disease, etc.)
  • Evidence of distant prostate cancer, i.e., including lymph nodes and/or metastasis of cancer on imaging
  • Bladder cancer
  • Urethral stricture/bladder neck contracture
  • Prostatitis NIH categories I, II and III
  • Implant near (<1 cm) the prostate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ExABlate MR Guided Focus Ultrasound
ExAblate MR Guided Focused Ultrasound - Local treatment of prostate lesions using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy.
Device: ExAblate MR Guided Focused Ultrasound
ExAblate MR Guided Focused Ultrasound - Local treatment of prostate lesions using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy.
Other Names:
  • ExAblate 2100 Prostate System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of ExAblate MRgFUS focal treatment of intermediate risk organ confined prostate lesions
Time Frame: 12 months
Evaluate incidence and severity of adverse events associated with ExAblate's MRgFUS focal treatment of intermediate risk organ confined prostate lesions. The risk of ExAblate treatment-related incontinence and impotence will also be assessed in this study.
12 months
Effectiveness of ExAblate MRgFUS focal treatment of intermediate risk organ-confined prostate lesions
Time Frame: 6 months
Determine the lesion control effect of ExAblate's MRgFUS focal treatment of intermediate risk organ-confined prostate lesions (confirmed by IMAGE-guided mapping biopsy results).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InSightec

Investigators

  • Principal Investigator: Behfar Ehdaie, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

October 1, 2019

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

August 2, 2012

First Submitted That Met QC Criteria

August 3, 2012

First Posted (Estimate)

August 6, 2012

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 4, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PCa003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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