European Radiology

, Volume 28, Issue 10, pp 4281–4287 | Cite as

Magnetic resonance guided focused high frequency ultrasound ablation for focal therapy in prostate cancer – phase 1 trial

  • Sangeet GhaiEmail author
  • Nathan Perlis
  • Uri Lindner
  • Eugen Hlasny
  • Masoom A. Haider
  • Antonio Finelli
  • Alexandre R. Zlotta
  • Girish S. Kulkarni
  • Theodorus H. van der Kwast
  • Stuart A. McCluskey
  • Walter Kucharczyk
  • John Trachtenberg



To evaluate the feasibility and safety of focal therapy for low–intermediate risk prostate cancer (PCa) with magnetic resonance-guided high frequency focused ultrasound (MRgFUS)


This IRB-approved phase 1 prospective study enrolled eight patients with prostate specific antigen (PSA) ≤ 10 ng/ml, ≤ cT2a and Gleason score ≤ 7 (4 + 3) disease following informed consent. Under MRI guidance, focused high frequency ultrasound energy was delivered to ablate the target tissue. Treatment-related adverse events were recorded. Oncologic outcomes were evaluated with multiparametric MRI, PSA and TRUS biopsy at 6 months following treatment.


Ten target lesions [six Gleason 6 lesions, two Gleason 7 (3 + 4) and two Gleason 7 (4 + 3)] were treated in eight men (prostate volume range, 25–50 cc; mean MRI time, 248 min per patient; mean sonication duration, 65 min). Mean target volume was 2.7 cc and mean post-treatment non-perfused volume was 4.3 cc. Quality of life parameters were similar between baseline and 6 months in 6/8 patients. All treated regions were negative on MRI; 4/8 patients and 6/10 target lesions (60%) were clear of disease on biopsy. One patient with 2-mm Gleason 8 disease in one of five cores from treatment site (4 + 3 disease at baseline) subsequently underwent prostatectomy with negative surgical margins. Three patients with low volume (5–15%) Gleason 6 residual disease were offered active surveillance. Mean PSA decreased from 5.06 at baseline to 3.4 ng/ml at 6 months.


MRgFUS is a feasible and safe method of noninvasively ablating low–intermediate risk PCa with acceptable short-term oncologic outcomes.

Key Points

Focal therapy selectively ablates locally confined, clinically significant index lesion with a margin while sparing rest of gland and adjacent vital structures.

Magnetic resonance-guided focused high frequency ultrasound surgery (MRgFUS) combines MRI with HIFU.

MRgFUS provides ability to monitor treatments in real time and allows a targeted approach for focal ablation.

MRgFUS is a feasible, safe method of noninvasively ablating low–intermediate risk PCa.

MRgFUS provides acceptable oncologic outcomes at 6 months.


Prostate cancer Magnetic resonance imaging High-intensity focused ultrasound ablation Interventional magnetic resonance imaging Image-guided surgery 



Active surveillance


Computed tomography


Focal therapy


High intensity focused ultrasound


Health-Related Quality of Life


International Consultation on Incontinence Questionnaire Short Form


International Index of Erectile Function


International Prostate Symptom Score


Multiparamteric magnetic resonance imaging


Magnetic resonance-guided high frequency Focused ultrasound surgery


Prostate cancer


Prostate-specific antigen


Transrectal ultrasound



This study has received funding by InSightec Ltd., the Ontario Research fund (ORF) and the Canadian Foundation for Innovation (CFI).

Compliance with ethical standards


The scientific guarantor of this publication is Sangeet Ghai.

Conflict of interest

The authors of this manuscript declare no relationships with any companies whose products or services may be related to the subject matter of the article.

Statistics and biometry

No complex statistical methods were necessary for this paper.

Informed consent

Written informed consent was obtained from all subjects (patients) in this study.

Ethical approval

Institutional review board approval was obtained.

Study subjects or cohorts overlap

The first four study subjects or cohorts (all with Gleason 6 disease) were previously reported in American Journal of Roentgenology (2015 Aug;205(2):W177-84). The first of these four patients was also reported without any follow up-in the Canadian Urological Association Journal (2012 Dec;6(6):E283-6).


• prospective

• experimental

• performed at one institution


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Copyright information

© European Society of Radiology 2018

Authors and Affiliations

  • Sangeet Ghai
    • 1
    • 2
    Email author
  • Nathan Perlis
    • 3
  • Uri Lindner
    • 3
    • 4
  • Eugen Hlasny
    • 1
  • Masoom A. Haider
    • 1
  • Antonio Finelli
    • 3
  • Alexandre R. Zlotta
    • 3
  • Girish S. Kulkarni
    • 3
  • Theodorus H. van der Kwast
    • 5
  • Stuart A. McCluskey
    • 6
  • Walter Kucharczyk
    • 1
  • John Trachtenberg
    • 3
  1. 1.Toronto Joint Department of Medical ImagingUniversity Health Network – Mt Sinai Hospital – Women’s College Hospital, University of TorontoTorontoCanada
  2. 2.1PMB-283Toronto General HospitalTorontoCanada
  3. 3.Division of Urology, Department of SurgeryUniversity Health Network, University of TorontoTorontoCanada
  4. 4.Department of UrologyKaplan Medical CenterRehovotIsrael
  5. 5.Laboratory Medicine ProgramUniversity Health Network, University of TorontoTorontoCanada
  6. 6.Department of AnaesthesiaUniversity Health Network, University of TorontoTorontoCanada

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