Back to resultsFocal ExAblate MR-Guided Focused Ultrasound Treatment for Management of Organ-Confined Intermediate Risk Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ExAblate MRgFUS
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, MRgFUS, ExAblate, Focused Ultrasound
Eligibility 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
Sites / Locations
- Toronto General Hospital
- Beijing Hospital
- Changhai Hospital of Shanghai
- St. Mary's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ExAblate MRgFUS
Arm Description
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.
Outcomes
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
Response will be based on mapping biopsy defined by Gleason 7 Score in any part of the prostate gland
Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary Outcome Measures
Percent of patients with negative biopsy
% 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
Treatment effect on patients' Quality of Life (QoL), i.e., urinary symptoms
Quality of Life - urinary continence - ICIQ-SF questionnaire score
Treatment effect on patients' Quality of Life, (QoL), i.e., urinary continence
Quality of Life - sexual function - IIEF-15 questionnaire score
Treatment effect on patients' Quality of Life, (QoL), i.e.,sexual function
Prostate Specific Antigen (PSA)
PSA levels and post-treatment PSA kinetics will be assessed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02968784
Brief Title
Focal ExAblate MR-Guided Focused Ultrasound Treatment for Management of Organ-Confined Intermediate Risk Prostate Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Sponsor Decision
Study Start Date
June 2016 (undefined)
Primary Completion Date
February 2, 2023 (Actual)
Study Completion Date
February 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InSightec
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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:
% of patients with negative 5-month follow-up biopsy results in the treated part of the prostate
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.
Urinary symptoms - IPSS
Urinary continence - ICIQ-UI-SF
Sexual function - IIEF-15
PSA levels and post-treatment PSA kinetics will also be assessed
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, MRgFUS, ExAblate, Focused Ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ExAblate MRgFUS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ExAblate MRgFUS
Other Intervention Name(s)
Focused Ultrasound
Intervention Description
ExAblate treatment of prostate cancer less than or equal to Grade 7
Primary Outcome Measure Information:
Title
The primary efficacy endpoint in this trial measured with whole-gland extended imaging-guided mapping biopsy, is Response scored dichotomously; success vs. failure
Description
Response will be based on mapping biopsy defined by Gleason 7 Score in any part of the prostate gland
Time Frame
24 months post treatment
Title
Adverse events
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
24 months post treatment
Secondary Outcome Measure Information:
Title
Percent of patients with negative biopsy
Description
% of patients with negative 5-month follow-up biopsy results in the treated part of the prostate
Time Frame
5 months post treatment
Title
Quality of Life - urinary symptoms - IPSS questionnaire score
Description
Treatment effect on patients' Quality of Life (QoL), i.e., urinary symptoms
Time Frame
24 months post treatment
Title
Quality of Life - urinary continence - ICIQ-SF questionnaire score
Description
Treatment effect on patients' Quality of Life, (QoL), i.e., urinary continence
Time Frame
24 months post treatment
Title
Quality of Life - sexual function - IIEF-15 questionnaire score
Description
Treatment effect on patients' Quality of Life, (QoL), i.e.,sexual function
Time Frame
24 months
Title
Prostate Specific Antigen (PSA)
Description
PSA levels and post-treatment PSA kinetics will be assessed
Time Frame
24 months post treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangeet Ghai, MD
Organizational Affiliation
Toronto General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Facility Name
Changhai Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
St. Mary's Hospital
City
London
ZIP/Postal Code
W2 INY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Focal ExAblate MR-Guided Focused Ultrasound Treatment for Management of Organ-Confined Intermediate Risk Prostate Cancer
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