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

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: NCT02968784
Recruitment Status : Terminated (Sponsor Decision)
First Posted : November 21, 2016
Last Update Posted : May 9, 2023
Sponsor:
Information provided by (Responsible Party):
InSightec

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Device: ExAblate MRgFUS Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: N/A
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
Study Start Date : June 2016
Actual Primary Completion Date : February 2, 2023
Actual Study Completion Date : February 2, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
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) 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 7 Score in any part of the prostate gland

  2. 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 :
  1. 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

  2. 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

  3. 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

  4. 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

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


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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:

  • PSA ≤ 20 ng/ml
  • Histologically proven PCa on imaging-guided transrectal or transperineal extended mapping biopsy
  • 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 wtachful waiting or active surveillance and not in need of imminent therapy
  • Gleason Score 7 (3+4 or 4+3) 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 findings; may have secondary Gleason 6 lesion on ipisilateral or contralateral side confirmed with biopsy and/or MRI

Exclusion Criteria:

  • Any Contraindication to MRI, such as: over-size limitations avoiding patient's positioning in the bore of MRI scanner, claustrophobia, implanted ferromagnetic materials or foreign objects, or known contraindication to utilization of MRI contrast agent (e.g., Gadolinium/Magnevist)
  • 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
  • Patient under androgen deprivation therapy (ADT), alpha reductase inhibitors, and/or other hormonal treatment within the past 6 months
  • 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
  • History of an invasive malignancy other than basal or squamous skin cancers in the last 5 years
  • Existing urethral or bladder neck contracture/stricture
  • Prostatitis NIH categories I, II and III
  • Implant near (<1cm) 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): NCT02968784


Locations
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Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
China, Beijing
Beijing Hospital
Beijing, Beijing, China, 100005
China, Shanghai
Changhai Hospital of Shanghai
Shanghai, Shanghai, China, 200433
United Kingdom
St. Mary's Hospital
London, United Kingdom, W2 INY
Sponsors and Collaborators
InSightec
Investigators
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Principal Investigator: Sangeet Ghai, MD Toronto General Hospital
More Information
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Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT02968784    
Other Study ID Numbers: PCa006
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: May 9, 2023
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by InSightec:
Prostate Cancer
MRgFUS
ExAblate
Focused Ultrasound
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases