Focal ExAblate MR-Guided Focused Ultrasound Treatment for Management of Organ-Confined Intermediate Risk Prostate Cancer
|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|
- 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
- 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
|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)|
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02968784
|Toronto General Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 2N2|
|Contact: Sangeet Ghai, MD Sangeet.Ghai@uhn.ca|
|Contact: Kateri Corr 416.946.4501 ext 5501 Kateri.Corr@uhn.ca|
|Korea, Republic of|
|Severance Hospital, Yonsei University Health System||Recruiting|
|Seoul, Korea, Republic of, 120-752|
|Contact: Na Young Huh, RN 010-2923-2567 firstname.lastname@example.org|
|Contact: Youn Kook Kim email@example.com|
|Principal Investigator: Dae Chul Yung, MD|
|St. Mary's Hospital||Recruiting|
|London, United Kingdom, W2 INY|
|Contact: Mathias Winkler 07957396866 firstname.lastname@example.org|
|Contact: Bozenna Borzyskowska 0203 312 1683 email@example.com|
|Principal Investigator: Wladyslaw Gedroyc, MD|
|Principal Investigator:||Sangeet Ghai, MD||Toronto General Hospital|