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

Titre officiel

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

Sommaire:

L’étude vise à montrer que ExAblateMD MRgFUS est une procédure sécuritaire pouvant retarder considérablement ou éliminer le besoin de subir un traitement définitif (c.-à-d., une prostatectomie radicale ou une radiothérapie) pour traiter un cancer de la prostate à risque intermédiaire confiné à l’organe.

Description de l'essai

Primary Outcome:

  • The primary efficacy endpoint in this trial measured with whole-gland extended imaging-guided mapping biopsy, is Response scored dichotomously; success vs. failure
  • Adverse events
Secondary Outcome:
  • Percent of patients with negative biopsy
  • Quality of Life - urinary symptoms - IPSS questionnaire score
  • Quality of Life - urinary continence - ICIQ-SF questionnaire score
  • Quality of Life - sexual function - IIEF-15 questionnaire score
  • Prostate Specific Antigen (PSA)
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
          3. PSA levels and post-treatment PSA kinetics will also be assessed

    Voir cet essai sur ClinicalTrials.gov

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