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Focal MR-Guided Focused Ultrasound Treatment of 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01657942
Recruitment Status : Unknown
Verified September 2020 by InSightec.
Recruitment status was:  Active, not recruiting
First Posted : August 6, 2012
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
InSightec

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Localized Intermediate Risk Prostate Lesions Device: ExAblate MR Guided Focused Ultrasound Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions
Actual Study Start Date : October 2013
Actual Primary Completion Date : October 2019
Estimated Study Completion Date : January 2021
Arms and Interventions
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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 Name: ExAblate 2100 Prostate System


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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).


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT01657942


Locations
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United States, California
City of Hope
Duarte, California, United States, 91010
University of California Los Angeles
Los Angeles, California, United States, 90095
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Florida
Sperling Prostate Center
Delray Beach, Florida, United States, 33445
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Weill Cornell Medical Center
New York, New York, United States, 10021
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
InSightec
Investigators
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Principal Investigator: Behfar Ehdaie, MD Memorial Sloan Kettering Cancer Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT01657942    
Other Study ID Numbers: PCa003
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by InSightec:
MRgFUS
Prostate
Intermediate Risk Prostate Lesions
Focal Prostate treatment
InSightec
 ExAblate
Non-invasive
Prostate cancer
Gleason 7