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Magnetic resonance imaging-guided transurethral ultrasound ablation in patients with localised prostate cancer: 3-year outcomes of a prospective Phase I study

Objectives To report the 3-year follow-up of a Phase I study of magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) in 30 men with localised prostate cancer. Favourable 12-month safety and ablation precision were previously described. Patients and Methods As a mandated...

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Main Authors: Nair, Shiva (Author) , Hatiboglu, Gencay (Author) , Relle, James (Author) , Hetou, Khalil (Author) , Hafron, Jason (Author) , Harle, Christopher (Author) , Kassam, Zahra (Author) , Staruch, Robert (Author) , Burtnyk, Mathieu (Author) , Bonekamp, David (Author) , Schlemmer, Heinz-Peter (Author) , Röthke, Matthias C. (Author) , Wolf, Maya Barbara (Author) , Pahernik, Sascha (Author) , Chin, Joseph L. (Author)
Format: Article (Journal)
Language:English
Published: 2021
In: BJU international
Year: 2021, Volume: 127, Issue: 5, Pages: 544-552
ISSN:1464-410X
DOI:10.1111/bju.15268
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1111/bju.15268
Verlag, lizenzpflichtig, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/bju.15268
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Author Notes:Shiva M. Nair, Gencay Hatiboglu, James Relle, Khalil Hetou, Jason Hafron, Christopher Harle, Zahra Kassam, Robert Staruch, Mathieu Burtnyk, David Bonekamp, Heinz-Peter Schlemmer, Matthias C. Roethke, Maya Mueller-Wolf, Sascha Pahernik and Joseph L. Chin
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Summary:Objectives To report the 3-year follow-up of a Phase I study of magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) in 30 men with localised prostate cancer. Favourable 12-month safety and ablation precision were previously described. Patients and Methods As a mandated safety criterion, TULSA was delivered as near whole-gland ablation, applying 3-mm margins sparing 10% of peripheral prostate tissue in 30 men. After 12-month biopsy and MRI, biannual follow-up included prostate-specific antigen (PSA), adverse events (AEs), and functional quality-of-life assessment, with repeat systematic biopsy at 3 years. Results A 3-year follow-up was completed by 22 patients. Between 1 and 3 years, there were no new serious or severe AEs. Urinary and bowel function remained stable. Erectile function recovered by 1 year and was stable at 3 years. The PSA level decreased 95% to a median (interquartile range) nadir of 0.33 (0.1-0.4) ng/mL, stable to 0.8 (0.4-1.6) ng/mL at 3 years. Serial biopsies identified clinically significant disease in 10/29 men (34%) and any cancer in 17/29 (59%). By 3 years, seven men had recurrence (four histological, three biochemical) and had undergone salvage therapy without complications (including six prostatectomies). At 3 years, three of 22 men refused biopsy, and two of the 22 (9%) had clinically significant disease (one new, one persistent). Predictors of salvage therapy requirement included less extensive ablation coverage and higher PSA nadir. Conclusion With 3-year Phase I follow-up, TULSA demonstrates safe and precise ablation for men with localised prostate cancer, providing predictable PSA and biopsy outcomes, without affecting functional abilities or precluding salvage therapy.
Item Description:Online veröffentlicht: 9. Oktober 2021
Gesehen am 29.07.2024
Physical Description:Online Resource
ISSN:1464-410X
DOI:10.1111/bju.15268

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