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Focal ExAblate MR-Guided Focused Ultrasound Treatment for Management of Organ-Confined Intermediate Risk Prostate Cancer

This study is currently recruiting participants.
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Verified August 2017 by InSightec
Information provided by (Responsible Party):
InSightec Identifier:
First received: September 29, 2016
Last updated: August 15, 2017
Last verified: August 2017
This study is intended to show that ExAblate™ MRgFUS is a safe procedure that can significantly postpone or eliminate the need of patients with organ confined intermediate risk prostate cancer to undergo a definitive treatment (i.e., Radical Prostatectomy or Radiation therapy) for their disease.

Condition Intervention
Prostate Cancer Device: ExAblate MRgFUS

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Focal ExAblate™ MR-Guided Focused Ultrasound (MRgFUS) Treatment for Management of Organ-Confined Intermediate Risk Prostate Cancer (OC-IRPC): Evaluation of Safety and Effectiveness

Resource links provided by NLM:

Further study details as provided by InSightec:

Primary Outcome Measures:
  • The primary efficacy endpoint in this trial measured with whole-gland extended imaging-guided mapping biopsy, is Response scored dichotomously; success vs. failure [ Time Frame: 24 months post treatment ]
    Response will be based on mapping biopsy defined by Gleason Score in any part of the prostate gland

  • Adverse events [ Time Frame: 24 months post treatment ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures:
  • Percent of patients with negative biopsy [ Time Frame: 5 months post treatment ]
    % of patients with negative 5-month follow-up biopsy results in the treated part of the prostate

  • Quality of Life - urinary symptoms - IPSS questionnaire score [ Time Frame: 24 months post treatment ]
    Treatment effect on patients' Quality of Life (QoL), i.e., urinary symptoms

  • Quality of Life - urinary continence - ICIQ-SF questionnaire score [ Time Frame: 24 months post treatment ]
    Treatment effect on patients' Quality of Life, (QoL), i.e., urinary continence

  • Quality of Life - sexual function - IIEF-15 questionnaire score [ Time Frame: 24 months ]
    Treatment effect on patients' Quality of Life, (QoL), i.e.,sexual function

  • Prostate Specific Antigen (PSA) [ Time Frame: 24 months post treatment ]
    PSA levels and post-treatment PSA kinetics will be assessed

Estimated Enrollment: 68
Study Start Date: June 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ExAblate MRgFUS

Up to 50% of the prostate gland will be treated. Treatment will include the Index lesion which is visible on MRI + tumor free margins of 3-mm; tumor free margins will not extend beyond the posterior aspect of the prostate capsule.

Urethral and bilateral neurovascular bundle preservation will be preferred whenever clinically justified.

Additional foci in the same hemisphere that are confirmed by biopsy and are < Gleason Score 7 (up to 3+4 or 4+3; no Gleason 5 pattern) or suspected to be positive for malignancy based on multi parametric-MRI) will also be included in the treated volume, providing total treatment volume does not exceed 50% of the gland.

Device: ExAblate MRgFUS
ExAblate treatment of prostate cancer less than or equal to Grade 7
Other Name: Focused Ultrasound

Detailed Description:

This study will evaluate the proportion of patients with organ-confined intermediate risk prostate cancer (OC-IRPC) undergoing focal ExAblate™ MRgFUS prostate treatment that will be free of clinically significant PCa which requires definitive treatment at 2 years after completion of their ExAblate™ treatment and to demonstrate the safety of focal ExAblate™ MRgFUS treatment.

Clinically significant PCa requiring definitive treatment is defined as pathology findings from whole-gland, imaging-guided, extended mapping biopsy of Gleason Score (GS) > 7

The primary efficacy endpoint in this trial, measured at 24 months with whole-gland extended imaging-guided mapping biopsy, is Response scored dichotomously for each subject as follows:

  • Response = 0 ("Failure"): Positive mapping biopsy defined as Gleason Score > 7 (indicating definitive treatment) in any part of their prostate gland
  • Response = 1 ("Success"): Negative mapping biopsy defined as Gleason Score < 7.

Safety of ExAblate™ treatment will be determined by evaluation of the incidence and severity of device related complications from the first treatment day visit throughout entire follow-up duration.

All adverse events will be captured and recorded. However, the safety of the ExAblate™ treatment will be defined by the incidence and severity of treatment or device related adverse events, grades III - V (CTCAE version 4.03; 2010-06-14).

Secondary Effectiveness Outcomes:

  1. % of patients with negative 5-month follow-up biopsy results in the treated part of the prostate
  2. Treatment effect on patients' Quality of Life (QoL), the following validated self-reported urogenital functioning assessment instruments will be used before and following treatment at pre-specified intervals.

    1. Urinary symptoms - IPSS
    2. Urinary continence - ICIQ-UI-SF
    3. Sexual function - IIEF-15
  3. PSA levels and post-treatment PSA kinetics will also be assessed

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

Inclusion Criteria:

  1. Male ≥ 50 years old
  2. Life expectancy > 10 years
  3. Prostate volume < 60 cc
  4. PSA ≤ 20 ng/ml
  5. Histologically proven PCa on imaging-guided transrectal or transperineal extended mapping biopsy
  6. Based on imaging-guided extended mapping biopsy:

    1. T1-T2b (positive foci detected in a single side of the prostate)
    2. Gleason Score of at least one focus will be: 7 (=3+4 or 4+3; no Gleason 5 pattern)
    3. Additional foci may be found in the same lobe, and may be of Gleason≤7 (up to 3+4 or 4+3; no Gleason 5 pattern)
    4. N0,M0
  7. Index lesion (of Gleason 7) must be visible on MRI
  8. Maximal diameter of any cancerous focus is 20mm, on MRI
  9. Maximal tumor length in contact with the prostate capsule is 5mm
  10. No extracapsular extension
  11. No involvement of the seminal vesicles
  12. Patient weight < 113 Kg
  13. Patient eligible for epidural or general anesthesia (as assessed by an anesthesiologist)
  14. Patient willing and able to give consent and attend all study visits as defined in the protocol.

Exclusion Criteria:

  1. Biopsy confirmed or MRI suspected lesion on the contralateral side of the prostate at screening
  2. ASA status > 2
  3. Any Contraindication to MRI, such as:

    3.1. Over-size limitations avoiding patient's positioning in the bore of MRI scanner 3.2. Claustrophobia 3.3. Implanted ferromagnetic materials or foreign objects 3.4. Known contraindication to utilization of MRI contrast agent (e.g., Gadolinium/Magnevist)

  4. Severely abnormal coagulation (INR>1.5)
  5. Patient with unstable cardiovascular status including:

    5.1. Unstable angina pectoris on medication 5.2. Documented myocardial infarction within 90 days prior to enrolment 5.3. Congestive heart failure NYHA class IV 5.4. Unstable arrhythmia status, already on anti-arrhythmic drugs 5.5. Severe hypertension (diastolic BP > 100 on medication) 5.6. Severe cerebrovascular disease (multiple CVA or CVA within the last 6 months)

  6. History of prostatectomy, radiation therapy to the pelvis for any other malignancy, brachytherapy, Cryotherapy, US-guided HIFU, orchiectomy, prostate photodynamic therapy, or prostate cancer-specific chemotherapy.
  7. Patients with apical index lesion that cannot be treated with tumor free margins while preserving at least 10-mm of their urethral sphincter.
  8. Patient under androgen deprivation therapy (ADT), alpha reductase inhibitors, and/or other hormonal treatment within the past 6 months
  9. Any rectal disease, pathology, anomaly, injury, previous treatment, or scarring which could change acoustic properties of the rectal wall, or might prevent safe probe insertion (e.g., inflammatory bowel disease, fistula, stenosis, fibrosis, or symptomatic hemorrhoids)
  10. History of an invasive malignancy other than basal or squamous skin cancers in the last 5 years
  11. Existing urethral or bladder neck contracture/stricture
  12. Patient with baseline symptoms of incontinence, defined as score of > 3 in the ICIQ-SF Questionnaire
  13. Active UTI
  14. Prostatitis NIH categories I, II and III
  15. Implant near (<1cm) the prostate
  16. Inability to avoid injury of any of the urethral sphincters or the bladder neck during treatment due to vicinity of detected cancer.
  17. Calcification of 2 mm or more in largest diameter neighboring the rectal wall (in a distance of less than 5 mm from the rectal wall) potentially interfering with the acoustic beam path.
  18. Interest in future fertility
  19. 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 identifier: NCT02968784

Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Sangeet Ghai, MD   
Contact: Kateri Corr    416.946.4501 ext 5501   
Korea, Republic of
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Na Young Huh, RN    010-2923-2567   
Contact: Youn Kook Kim   
Principal Investigator: Dae Chul Yung, MD         
United Kingdom
St. Mary's Hospital Recruiting
London, United Kingdom, W2 INY
Contact: Mathias Winkler    07957396866   
Contact: Bozenna Borzyskowska    0203 312 1683   
Principal Investigator: Wladyslaw Gedroyc, MD         
Sponsors and Collaborators
Principal Investigator: Sangeet Ghai, MD Toronto General Hospital
  More Information

Responsible Party: InSightec Identifier: NCT02968784     History of Changes
Other Study ID Numbers: PCa006
Study First Received: September 29, 2016
Last Updated: August 15, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by InSightec:
Prostate Cancer
Focused Ultrasound

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on September 21, 2017