Try our beta test site

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by InSightec
Sponsor:
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT01657942
First received: August 2, 2012
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
The hypothesis of this study is that focal treatment with ExAblate MRgFUS has the potential to be an effective non-invasive treatment for low to 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 Intervention Phase
Localized Low and Intermediate Risk Prostate Lesions
Device: ExAblate MR Guided Focused Ultrasound
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Focal MR-Guided Focused Ultrasound Treatment of Localized Low and Intermediate Risk Prostate Lesions

Resource links provided by NLM:


Further study details as provided by InSightec:

Primary Outcome Measures:
  • Safety [ Time Frame: 12 months ]
    valuate incidence and severity of adverse events associated with ExAblate's MRgFUS focal treatment of low and intermediate risk organ confined prostate lesions. The risk of ExAblate treatment-related incontinence and impotence will also be assessed in this study.

  • Effectiveness [ Time Frame: 6 months ]
    Determine the lesion control effect of ExAblate's MRgFUS focal treatment of low risk organ-confined prostate lesions (confirmed by IMAGE-guided mapping biopsy results).


Estimated Enrollment: 100
Actual Study Start Date: October 2013
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Objective of this feasibility trial is to assess safety and initial effectiveness of ExAblate MRgFUS in the treatment of low and 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 low 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 low risk organ-confined prostate lesions (confirmed by IMAGE-guided mapping biopsy results).

  Eligibility

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

Inclusion Criteria

  1. Male subjects age 50 and older.
  2. 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.
  3. Patient with low or 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.
  4. Patient with PSA less than or equal to 20 ng/mL
  5. Gleason score 6 (3 + 3) or 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.
  6. Single hemilateral index Gleason 7 or Gleason 6 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.
  7. Gleason 7 or Gleason 6 tumors must be MRI visible:

    1. In the event that a tumor is in contact with the capsule, the length of the contact should be ≤ 5 mm, on axial images.
    2. Largest imaging dimension of cancerous finding < 20-mm
  8. No definite evidence of extracapsular extension or seminal invasion by MRI
  9. Patient should be eligible for both spinal/epidural anesthesia (planned procedure), and general anesthesia (in case of complication, requiring intervention).
  10. Patient is willing and able to give consent attend all study visits and complete all questionnaires as defined in the protocol
  11. Tumor distance, including tumor free margins, should not be more than 40mm from the rectal wall.

Exclusion Criteria

  1. ASA status > 2
  2. Contraindications to MRI 2.1 Claustrophobia 2.2 Implanted ferromagnetic materials or foreign objects 2.3 Known intolerance to the MRI contrast agent
  3. Severely abnormal coagulation (INR>1.5)
  4. Patients with unstable cardiac status including:

    4.1 Unstable angina pectoris on medication 4.2 Patients with documented myocardial infarction within 40 days prior to enrollment 4.3 Congestive heart failure NYHA class IV 4.4 Patients with unstable arrhythmia status, already on anti-arrhythmic drugs

  5. Severe hypertension (diastolic BP > 100 on medication)
  6. Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
  7. 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.
  8. Patient under medications that can affect PSA for the last 3 months prior to MRgFUS treatment (Androgen Deprivation Treatment; alpha reductase inhibitors)
  9. Patients with lesions of Gleason 7 or greater outside the planned treatment area.
  10. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (approximately 3 hrs. sonication time)
  11. 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).
  12. Any spinal pathology which can prevent safe administration of epidural/spinal anesthesia
  13. Identified calcification of 2 mm or more in largest diameter neighboring the rectal wall (in a distance of less than 5 mm) and interfering with the acoustic beam path.
  14. Lower limb musculoskeletal fixed deformities preventing probe insertion or patient positioning during procedure.
  15. Prostate with multiple cystic lesions.
  16. Evidence of distant prostate cancer, i.e., including lymph nodes and/or metastasis of cancer on imaging
  17. Bladder cancer
  18. Urethral stricture/bladder neck contracture
  19. Active UTI
  20. Prostatitis NIH categories I, II and III.
  21. Compromised renal function
  22. Implant near (<1 cm) the prostate
  23. Interest in future fertility
  24. Current participation in another clinical investigation of a medical device or a drug or has participated in such a study within 30 days prior to study enrollment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657942

Locations
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Bianca Del Vecchio    626-256-4673 ext 64402    MRgFUS@coh.org   
Principal Investigator: Jeffrey Wong, M.D.         
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Tammy Floore, BSN, MBA    310-481-7510    tfloore@mednet.ucla.edu   
Principal Investigator: Steven S Raman, MD         
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Denise Haas    650-736-1252    dhaas@stanford.edu   
Principal Investigator: Geoffrey Sonn, MD         
United States, Florida
Sperling Prostate Center Not yet recruiting
Aventura, Florida, United States, 33180
Contact: John Gentile    917-841-7106    john.gentile@sperlingmedical.com   
Principal Investigator: Dan Sperling, MD         
United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Louise Greenberg    617-732-5441    lgreenberg@partners.org   
Principal Investigator: Clare Tempany, M.D.         
United States, Michigan
Henry Ford Hospital: Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Christopher T Tallman, MD       ctallma1@hfhs.org   
Principal Investigator: Mani Menon, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Connie Sathre    507-538-0540    sathre@mayo.edu   
Principal Investigator: David Woodrum, MD         
United States, New York
Weill Cornell Medical Center Recruiting
New York, New York, United States, 10021
Contact: Jamie Stern    212-746-9748    jas2071@med.cornell.edu   
Principal Investigator: Marc H Schiffman, MD         
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Maha Mamoor    646-227-2257    mamoorm@mskcc.org   
Contact: Brian Kunzel    646-227-2259    kunzelb@mskcc.org   
Principal Investigator: Behfar Ehdaie, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Amy B Smith, BA    434-243-7231    ajb6bb@virginia.edu   
Principal Investigator: Timothy Showalter, MD         
Sponsors and Collaborators
InSightec
Investigators
Principal Investigator: Behfar Ehdaie, MD Memorial Sloan Kettering Cancer Center
  More Information

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT01657942     History of Changes
Other Study ID Numbers: PCa003
Study First Received: August 2, 2012
Last Updated: March 21, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by InSightec:
MRgFUS
Prostate
Low and Intermediate Risk Prostate Lesions
Focal Prostate treatment
InSightec
ExAblate
Non-invasive
Gleason 6 or Gleason 7

ClinicalTrials.gov processed this record on March 23, 2017