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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

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World Journal of Urology Aims and scope Submit manuscript

Abstract

Objectives

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.

Results

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.

Conclusion

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.

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Abbreviations

CEM43:

Cumulative equivalent minutes at 43 °C

IIEF:

International index for erectile function

IPSS:

International prostate symptom score

IQR:

Interquartile range

MRI:

Magnetic resonance imaging

PCa:

Prostate cancer

PS:

Positioning system

QoL:

Quality of life

TACT:

TULSA-PRO Ablation Clinical Trial

TULSA:

Transurethral ultrasound ablation

UA:

Ultrasound applicator

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Funding

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

Author information

Authors and Affiliations

  1. Department of Urology, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany

    G. Hatiboglu, V. Popeneciu, S. Pahernik, G. Tosev, J. P. Radtke, M. Hohenfellner & J. N. Nyarangi-Dix

  2. German Cancer Research Center (DKFZ), Heidelberg, Germany

    D. Bonekamp & H. P. Schlemmer

  3. Profound Medical Inc., Toronto, ON, Canada

    M. Burtnyk & R. Staruch

  4. Department of Anaesthesiology, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany

    J. Motsch

Authors
  1. G. Hatiboglu
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Contributions

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.

Corresponding author

Correspondence to G. Hatiboglu.

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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.

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

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Hatiboglu, G., Popeneciu, V., Bonekamp, D. et al. 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. World J Urol 38, 343–350 (2020). https://doi.org/10.1007/s00345-019-02784-w

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