Table 1. Focal ultrasound ablation for localized PCa patients.
Author | Country | Study type | Eligibility criteria | Intervention | Outcomes and complications | ||
PCa, prostate cancer; PSA, prostate-specific antigen; GG, grade group; MRI, magnetic resonance imaging; TULSA, transurethral ultrasound ablation; PET-CT, positron emission tomography-computed tomography; csPCa, clinically significant PCa; ISUP, International Society of Urological Pathology; mpMRI, multiparametric magnetic resonance imaging; QoL, quality of life; TF, treatment failure; HR, hazard ratio; HIFU, high-intensity focused ultrasound; RP, radical prostatectomy. | |||||||
Klotz L.H. et al. (A0964) | Multiple countries | Prospective trial | Stage equal or smaller than T2b, PSA equal or smaller than 15 ng/mL, and GG 1−2. | MRI-guided TULSA in males with localized PCa. Inside-out thermal coagulation of prostate tissues under real-time, closed-loop MRI thermometry control enables precise and automatic adjustment of treatment parameters. | Median prostate volume reduced to 2.8 mL after one year and median PSA reduced to 0.9 ng/mL after four years. Effective disease control up to four years, good adverse event profile. | ||
Anttinen M.H.J. et al. (A0965) | Finland | Prospective study | mpMRI and 18-F PSMA-1007 PET-CT were used to rule out extra prostatic diseases. | Patients underwent either whole-gland or partial sTULSA, by mpMRI, PSMA PET-CT, and prostate biopsy targeting the treatment area plus areas suspicious in imaging. | Median PSA at 12 months after sTULSA was 0.19 ng/mL, 23/26 without any PCa in the treated area. Post-void residual volume improved by 33.3% and degradation of 41%, 37% and 37% were recorded for average flow rate, Qmax and voided volume, respectively. | ||
Yli-Pietilä E.H.M. et al. (A0966) |
Finland | Prospective study | MRI-visible and csPCa, high volume ISUP 1 (>2 positive cancer cores or ≥50% cancer in a core) or ≥ISUP 2. | Receive whole gland or focal MRI-guided transurethral ultrasound ablation. At 6 and 12 months’ follow-up, mpMRI was performed. At 12 months, biopsies were acquired. | Twenty-eight of 39 (72%) patients were free of in-field csPCa, with median (IQR) PSA of 0.81 ng/mL, stable median average flow rate and Qmax, but with low impact on QoL. | ||
Ebner A. et al. (A0967) |
Austria, Sweden, Switzerland |
Prospective trial | Clinically significant, localized, unilateral and low- or intermediate-risk PCa. | Focal high-intensity focused ultrasound therapy | Three of ten cores taken at initial biopsy were positive. Sixteen percent of TFs occurred. In multivariable-adjusted analysis, only T stage evolved as an independent predictor of TF [HR, 5.57 (1.52−20.32)]. | ||
Rischmann P. et al. (LB08) | France | Cohort study | Low- or intermediate-risk PCa (cT1−2NxM0, GG 1 or 2, PSA<15 ng/mL) not eligible for active surveillance, with 4/6 sextants invaded and a prebiopsy mpMRI with or without target. Patients were >69 years old in HIFU arm (French guidelines) and had a life expectancy >10 years in RP arm. | HIFU vs. RP | At 30 months, the salvage treatment-free survival was significantly higher in HIFU arm (90.1%) compared with RP arm (86.8%) with a risk of salvage treatment >1.2-fold higher after RP and better continence and erectile function outcomes after HIFU. |