Magnetic resonance imaging-guided transurethral ultrasound ablation of prostate tissue in patients with localized prostate cancer: single-center evaluation of 6-month treatment safety and functional outcomes of intensified treatment parameters

  • G. HatibogluEmail author
  • V. Popeneciu
  • D. Bonekamp
  • M. Burtnyk
  • R. Staruch
  • S. Pahernik
  • G. Tosev
  • J. P. Radtke
  • J. Motsch
  • H. P. Schlemmer
  • M. Hohenfellner
  • J. N. Nyarangi-Dix
Original Article



To evaluate the effect of intensified treatment parameters on safety, functional outcomes, and PSA after MR-Guided Transurethral Ultrasound Ablation (TULSA) of prostatic tissue.

Patients and methods

Baseline and 6-month follow-up data were collected for a single-center cohort of the multicenter Phase I (n = 14/30 at 3 sites) and Pivotal (n = 15/115 at 13 sites) trials of TULSA in men with localized prostate cancer. The Pivotal study used intensified treatment parameters (increased temperature and spatial extent of ablation coverage). The reporting site recruited the most patients to both trials, minimizing the influence of physician experience on this comparison of adverse events, urinary symptoms, continence, and erectile function between subgroups of both studies.


For Phase I and TACT patients, median age was 71.0 and 67.0 years, prostate volume 41.0 and 44.5 ml, and PSA 6.7 and 6.7 ng/ml, respectively. All 14 Phase I patients had low-risk prostate cancer, whereas 7 of 15 TACT patients had intermediate-risk disease. Baseline IIEF, IPSS, quality of life, and pad use were similar between groups. Pad use at 1 month and quality of life at 3 months favored Phase I patients. At 6 months, there were no significant differences in functional outcomes or adverse events.


TULSA demonstrated acceptable clinical safety in Phase I trial. Intensified treatment parameters in the TACT Pivotal trial increased ablation coverage from 90 to 98% of the prostate without affecting 6-month adverse events or functional outcomes. Long-term follow-up and 12-month biopsies are needed to evaluate oncological safety.


TULSA MRI-guided Outcome Phase I Pivotal 



Cumulative equivalent minutes at 43 °C


International index for erectile function


International prostate symptom score


Interquartile range


Magnetic resonance imaging


Prostate cancer


Positioning system


Quality of life


TULSA-PRO Ablation Clinical Trial


Transurethral ultrasound ablation


Ultrasound applicator


Author contribution

GH: project development, data collection, data analysis, manuscript writing and editing. VP: data collection, data analysis. DB: data collection, data analysis, manuscript writing and editing. MB: project development, data analysis, manuscript writing and editing. RS: project development, data analysis, manuscript writing and editing. SP: project development, data collection, data analysis. GT: data collection, data analysis. JPR: data analysis, manuscript writing and editing. JM: data collection, supervision. HPS: project development, supervision, critical revision of manuscript. MH: project development, manuscript writing and editing, supervision, critical revision of manuscript. JNN-D: data analysis, manuscript writing and editing, supervision, critical revision of manuscript.


Profound Medical Inc. helped design and conduct the study, manage and analyze the data, and prepare and approve the manuscript.

Compliance with ethical standards

Conflict of interest

R. Staruch and M. Burtnyk are employees of Profound Medical and receive a salary and stock options. The other authors declare, that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.


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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • G. Hatiboglu
    • 1
    Email author
  • V. Popeneciu
    • 1
  • D. Bonekamp
    • 2
  • M. Burtnyk
    • 3
  • R. Staruch
    • 3
  • S. Pahernik
    • 1
  • G. Tosev
    • 1
  • J. P. Radtke
    • 1
  • J. Motsch
    • 4
  • H. P. Schlemmer
    • 2
  • M. Hohenfellner
    • 1
  • J. N. Nyarangi-Dix
    • 1
  1. 1.Department of UrologyUniversity of HeidelbergHeidelbergGermany
  2. 2.German Cancer Research Center (DKFZ)HeidelbergGermany
  3. 3.Profound Medical Inc.TorontoCanada
  4. 4.Department of AnaesthesiologyUniversity of HeidelbergHeidelbergGermany

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