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MRI-guided transurethral ultrasound ablation (TULSA) demonstrated efficacy and safety as a treatment for patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), according to findings from a phase 1 trial published in BJU International.1
At 12 months’ follow-up, TULSA led to an 82% improvement in IPSS among the 10 enrolled patients. The treatment also resulted in a 101% improvement in median Qmax. At 1 year, the median reduction in prostate volume was 33% and the median reduction in PSA was 48%.
“TULSA appears to be a safe and effective treatment for benign prostatic obstruction (BPO), with promising 1-year follow-up outcomes. Further studies with larger cohorts are needed to confirm the observed results,” the authors wrote in their conclusion.
The prospective, investigator-initiated phase 1 trial (NCT03350529) included 10 men with BPH-related LUTS in need of surgical intervention. At baseline and every 3 months thereafter, the investigators obtained uroflowmetry and PSA data, and several functional questionnaires were completed. These included the EPIC-26, IPSS, and IIEF-5. Patients received MRIs at baseline, 3 months, and 12 months.
The median age at baseline was 68 years (interquartile range [IQR], 63-72) and the median prostate volume was 53 ml (IQR, 45-66). At baseline, 4 patients were severely symptomatic and 6 patients were moderately symptomatic. Overall, 9 patients were receiving BPO medication at baseline.
The investigators noted that patient improvement was already observed at 3 months. On the IPSS, on which a lower score is better, the median score was 17.5 (IQR, 15.3-23.0) at baseline and 4.0 (IQR, 2.3-6.3) at 12 months. Over the same period, the median Qmax improved from 12.4 ml/s (IQR, 8.8-17.6) to 21.8 ml/s (IQR, 17.6-26.5).
Between baseline and 12 months, there were no reported changes in continence, erectile function, bowel function, or sexual function. Among the 6 men with normal ejaculatory function at baseline, 5 had normal antegrade ejaculations at 12 months.
All 9 patients receiving BPO medication at baseline discontinued the medication after receiving TULSA. According to the investigators, there were no severe adverse events with the TULSA procedure.
TULSA in prostate cancer
TULSA is also being explored in men with localized prostate cancer. Published 3-year data for 22 patients with localized prostate cancer who received TULSA showed that bowel and urinary function remained stable at the 3-year mark.2 In this group, erectile function was recovered by the 1-year mark and remained stable at 3 years. Overall, PSA level from baseline was reduced by 95% to a median nadir of 0.33 ng/mL, which was stable to 0.8 ng/mL at 3 years. Three of the 22 men refused biopsy at the 3-year follow-up. Of the patients who received a biopsy, 2 had clinically significant disease (1 new, 1 persistent).
Based on these findings the authors wrote in their conclusion, “With 3-year phase 1 follow-up, TULSA demonstrates safe and precise ablation for men with localized prostate cancer, providing predictable PSA and biopsy outcomes, without affecting functional abilities or precluding salvage therapy.”
1. Viitala A, Anttinen M, Wright C, et al. MRI-guided transurethral ultrasound ablation for BPH: 12-month clinical outcomes of a phase I study [published online ahead of print June 23, 2021]. BJU Int. doi: 10.1111/bju.15523
2. Nair SM, Hatiboglu G, Relle J, et al. Magnetic resonance imaging-guided transurethral ultrasound ablation in patients with localized prostate cancer: 3-year outcomes of a prospective Phase I study. BJU Int. 2021;127(5):544-552. doi: 10.1111/bju.15268