Advertisement

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 Ghai
  • 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
Oncology

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.

Keywords

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

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

Notes

Funding

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

Compliance with ethical standards

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

References

  1. 1.
    Cooperberg MR, Lubeck DP, Meng MV, Mehta SS, Carroll PR (2004) The changing face of low-risk prostate cancer: trends in clinical presentation and primary management. J Clin Oncol 22:2141–2149CrossRefGoogle Scholar
  2. 2.
    Morash C, Tey R, Agbassi C et al (2015) Active surveillance for the management of localized prostate cancer: guideline recommendations. Can Urol Assoc J 9:171–178CrossRefGoogle Scholar
  3. 3.
    Pinthus JH, Witkos M, Fleshner NE et al (2006) Prostate cancers scored as Gleason 6 on prostate biopsy are frequently Gleason 7 tumors at radical prostatectomy: implication on outcome. J Urol 176:979–984 discussion 84CrossRefGoogle Scholar
  4. 4.
    Richard PO, Alibhai SM, Panzarella T et al (2016) The uptake of active surveillance for the management of prostate cancer: a population-based analysis. Can Urol Assoc J 10:333–338CrossRefGoogle Scholar
  5. 5.
    Madalinska JB, Essink-Bot ML, de Koning HJ, Kirkels WJ, van der Maas PJ, Schroder FH (2001) Health-related quality-of-life effects of radical prostatectomy and primary radiotherapy for screen-detected or clinically diagnosed localized prostate cancer. J Clin Oncol 19:1619–1628CrossRefGoogle Scholar
  6. 6.
    Potosky AL, Davis WW, Hoffman RM et al (2004) Five-year outcomes after prostatectomy or radiotherapy for prostate cancer: the prostate cancer outcomes study. J Natl Cancer Inst 96:1358–1367CrossRefGoogle Scholar
  7. 7.
    Karavitakis M, Winkler M, Abel P, Livni N, Beckley I, Ahmed HU (2011) Histological characteristics of the index lesion in whole-mount radical prostatectomy specimens: implications for focal therapy. Prostate Cancer Prostatic Dis 14:46–52CrossRefGoogle Scholar
  8. 8.
    Radtke JP, Schwab C, Wolf MB et al (2016) Multiparametric magnetic resonance imaging (MRI) and MRI-transrectal ultrasound fusion biopsy for index tumor detection: correlation with radical prostatectomy specimen. Eur Urol 70:846–853CrossRefGoogle Scholar
  9. 9.
    Lindner U, Trachtenberg J, Lawrentschuk N (2010) Focal therapy in prostate cancer: modalities, findings and future considerations. Nat Rev Urol 7:562–571CrossRefGoogle Scholar
  10. 10.
    Valerio M, Emberton M, Ahmed HU (2014) Focal therapy will become a standard option for selected men with localized prostate cancer. J Clin Oncol 32:3680–3681CrossRefGoogle Scholar
  11. 11.
    Jolesz FA (2009) MRI-guided focused ultrasound surgery. Ann Rev Med 60:417–430CrossRefGoogle Scholar
  12. 12.
    Schulman AA, Tay KJ, Robertson CN, Polascik TJ (2017) High-intensity focused ultrasound for focal therapy: reality or pitfall? Curr Opin Urol 27:138–148CrossRefGoogle Scholar
  13. 13.
    Ghai S, Louis AS, Van Vliet M et al (2015) Real-time MRI-guided focused ultrasound for focal therapy of locally confined low-risk prostate cancer: feasibility and preliminary outcomes. AJR Am J Roentgenol 205:W177–W184CrossRefGoogle Scholar
  14. 14.
    Lindner U, Ghai S, Spensieri P et al (2012) Focal magnetic resonance guided focused ultrasound for prostate cancer: initial North American experience. Can Urol Assoc J 6:E283–E286CrossRefGoogle Scholar
  15. 15.
    Orihuela E, Pow-Sang M, Motamedi M, Cowan DF, Warren MM (1996) Mechanism of healing of the human prostatic urethra following thermal injury. Urology 48:600–608CrossRefGoogle Scholar
  16. 16.
    Ghai S, Trachtenberg J (2014) Prostate cancer: a consensus on trial design for focal therapy. Nat Rev Urol 11:190–192CrossRefGoogle Scholar
  17. 17.
    Ahmed HU, Hindley RG, Dickinson L et al (2012) Focal therapy for localised unifocal and multifocal prostate cancer: a prospective development study. Lancet Oncol 13:622–632CrossRefGoogle Scholar
  18. 18.
    Rischmann P, Gelet A, Riche B et al (2017) Focal high intensity focused ultrasound of unilateral localized prostate cancer: a prospective multicentric hemiablation study of 111 patients. Eur Urol 71:267–273CrossRefGoogle Scholar
  19. 19.
    Hynynen K, McDannold N (2004) MRI guided and monitored focused ultrasound thermal ablation methods: a review of progress. Int J Hyperthermia 20:725–737CrossRefGoogle Scholar
  20. 20.
    Ahmed HU, Dickinson L, Charman S et al (2015) Focal ablation targeted to the index lesion in multifocal localised prostate cancer: a prospective development study. Eur Urol 68:927–936CrossRefGoogle Scholar
  21. 21.
    Chapelon JY, Rouvière O, Crouzet S, Gelet A (2016) Prostate focused ultrasound therapy. Adv Exp Med Biol 880:21–41CrossRefGoogle Scholar
  22. 22.
    Perez-Reggeti JI, Sanchez-Salas R, Sivaraman A et al (2016) High intensity focused ultrasound with Focal-One® device: Prostate-specific antigen impact and morbidity evaluation during the initial experience. Actas Urol Esp 40:608–614CrossRefGoogle Scholar
  23. 23.
    Le Nobin J, Rosenkrantz AB, Villers A et al (2015) Image guided focal therapy for magnetic resonance imaging visible prostate cancer: defining a 3-dimensional treatment margin based on magnetic resonance imaging histology co-registration analysis. J Urol 194:364–370CrossRefGoogle Scholar
  24. 24.
    Priester A, Natarajan S, Khoshnoodi P et al (2017) Magnetic resonance imaging underestimation of prostate cancer geometry: use of patient specific molds to correlate images with whole mount pathology. J Urol 197:320–326CrossRefGoogle Scholar
  25. 25.
    Eggener SE, Yousuf A, Watson S, Wang S, Oto A (2016) Phase II evaluation of magnetic resonance imaging guided focal laser ablation of prostate cancer. J Urol 196:1670–1675CrossRefGoogle Scholar

Copyright information

© European Society of Radiology 2018

Authors and Affiliations

  • Sangeet Ghai
    • 1
    • 2
  • 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

Personalised recommendations