NCT02968784

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

Focal ExAblate™ MR-Guided Focused Ultrasound (MRgFUS) Treatment for Management of Organ-Confined Intermediate Risk Prostate Cancer (OC-IRPC): Evaluation of Safety and Effectiveness

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: InSightec · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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: 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

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	ExAblate MRgFUS	ExAblate treatment of prostate cancer less than or equal to Grade 7

Timeline

• Start date: 2016-06-01
• Primary completion: 2023-02-02
• Completion: 2023-02-02
• First posted: 2016-11-21
• Last updated: 2023-05-09

Locations

4 sites across 3 countries: Canada, China, United Kingdom