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

Abstract

S.M.N. and G.H. contributed equally towards the data analysis and article preparation. ObjectivesTo 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 MethodsAs 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. ResultsA 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. ConclusionWith 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.

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Cancer: A Systematic Review

“…For the 22 men with a complete 3-year follow-up, 13/22 and 11/22 had erections sufficient for penetration at baseline and follow-up. 12 For the 16 men with a complete 5-year follow-up, 9/16 and 7/16 had erections sufficient for penetration at baseline and follow-up. 13 …”

“…Feasibility was also assessed in a prospective Phase I study ( n = 30) 11 with up to 5-year follow-up. 12 , 13 However, a nononcologic treatment plan was applied and the intent of the study was to assess the feasibility and not to achieve definitive treatment. Therefore, the rates of salvage treatment, clinically significant disease, MRI recurrence, and BCR from the Phase I study were not included in the present synthesis.…”

Single-Center Evaluation of Treatment Success Using Two Different Protocols for MRI–Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer

“…Routine follow-up biopsy at 12 months is therefore recommended to ensure timely detection of residual disease. For patients with tumor recurrence, standard salvage treatments like radical prostatectomy ( 19 ) or radiotherapy ( 20 ) are viable options.…”

Magnetic resonance imaging-guided ultrasound ablation for prostate cancer – A contemporary review of performance

“…At 12-month follow-up, 9/29 (31%) patients had a positive 12-core transrectal, US-guided biopsy for csPCa (GG1 >10mm, GG2 >3 mm, or any GG3 disease), while 16/29 patients had a positive biopsy for any disease ( 36 ). A subsequent study completed 3 years of follow-up in 22 individuals from the original study ( 39 ), during which no new serious or severe adverse events were reported. Erectile function and PSA levels were also stable at 3 years.…”

“…Erectile function and PSA levels were also stable at 3 years. Overall, 10/29 (34%) participants had csPCa at 3 years, including 19 men who had repeat biopsy at the 3-year mark, and 10 men who only completed biopsy at 12 months ( 39 ).…”