Focal ExAblate MR-Guided Focused Ultrasound Treatment for Management of Organ-Confined Intermediate Risk Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT02968784|
Recruitment Status : Recruiting
First Posted : November 21, 2016
Last Update Posted : August 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: ExAblate MRgFUS||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
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
- 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
- Adverse events [ Time Frame: 24 months post treatment ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- 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
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
|Toronto General Hospital||Active, not recruiting|
|Toronto, Ontario, Canada, M5G 2N2|
|China, HongKou District|
|Shanghai Jiaotong University No.1 Hospital||Recruiting|
|Shanghai, HongKou District, China, 200080|
|Contact: Yuan Yuan 13761545442 email@example.com|
|Principal Investigator: Han Wang, MD|
|Changhai Hospital of Shanghai||Recruiting|
|Shanghai, Shanghai, China, 200433|
|Contact: Yuan Yuan 13761545442 firstname.lastname@example.org|
|Principal Investigator: Yinghao Sun, MD|
|Sub-Investigator: Jianping Lu, MD|
|Sub-Investigator: Haifeng Wang, MD|
|Sub-Investigator: Yongwei Yu, MD|
|Sub-Investigator: Yi Zhou, MD|
|Sub-Investigator: Hong Shi, MD|
|Sub-Investigator: Guodong Jing, MD|
|Sub-Investigator: Shiyue Chen, MD|
|Sub-Investigator: Zhen Wang, MD|
|Sub-Investigator: Yukun Chen, MD|
|Sub-Investigator: Haiyan Zhou, MD|
|Korea, Republic of|
|Severance Hospital, Yonsei University Health System||Withdrawn|
|Seoul, Korea, Republic of, 120-752|
|St. Mary's Hospital||Completed|
|London, United Kingdom, W2 INY|
|Principal Investigator:||Sangeet Ghai, MD||Toronto General Hospital|