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

  • Oncology
  • Published:
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Abstract

Objectives

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)

Methods

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.

Results

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.

Conclusion

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.

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Abbreviations

AS:

Active surveillance

CT:

Computed tomography

FT:

Focal therapy

HIFU:

High intensity focused ultrasound

HRQoL:

Health-Related Quality of Life

ICIQ-SF:

International Consultation on Incontinence Questionnaire Short Form

IIEF-15:

International Index of Erectile Function

IPSS:

International Prostate Symptom Score

mpMRI:

Multiparamteric magnetic resonance imaging

MRgFUS:

Magnetic resonance-guided high frequency Focused ultrasound surgery

PCa:

Prostate cancer

PSA:

Prostate-specific antigen

TRUS:

Transrectal ultrasound

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Funding

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

Author information

Authors and Affiliations

  1. Toronto Joint Department of Medical Imaging, University Health Network – Mt Sinai Hospital – Women’s College Hospital, University of Toronto, Toronto, ON, Canada

    Sangeet Ghai, Eugen Hlasny, Masoom A. Haider & Walter Kucharczyk

  2. 1PMB-283, Toronto General Hospital, 585 University Avenue, Toronto, ON, M5G 2N2, Canada

    Sangeet Ghai

  3. Division of Urology, Department of Surgery, University Health Network, University of Toronto, Toronto, ON, Canada

    Nathan Perlis, Uri Lindner, Antonio Finelli, Alexandre R. Zlotta, Girish S. Kulkarni & John Trachtenberg

  4. Department of Urology, Kaplan Medical Center, Rehovot, Israel

    Uri Lindner

  5. Laboratory Medicine Program, University Health Network, University of Toronto, Toronto, ON, Canada

    Theodorus H. van der Kwast

  6. Department of Anaesthesia, University Health Network, University of Toronto, Toronto, ON, Canada

    Stuart A. McCluskey

Authors
  1. Sangeet Ghai
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  2. Nathan Perlis
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  3. Uri Lindner
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  4. Eugen Hlasny
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  5. Masoom A. Haider
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  6. Antonio Finelli
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  7. Alexandre R. Zlotta
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  8. Girish S. Kulkarni
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  9. Theodorus H. van der Kwast
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  10. Stuart A. McCluskey
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  11. Walter Kucharczyk
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  12. John Trachtenberg
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Corresponding author

Correspondence to Sangeet Ghai.

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Guarantor

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).

Methodology

• prospective

• experimental

• performed at one institution

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Ghai, S., Perlis, N., Lindner, U. et al. Magnetic resonance guided focused high frequency ultrasound ablation for focal therapy in prostate cancer – phase 1 trial. Eur Radiol 28, 4281–4287 (2018). https://doi.org/10.1007/s00330-018-5409-z

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  • DOI: https://doi.org/10.1007/s00330-018-5409-z

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