Table 1 Key findings of major PCa MRgFUS studies.
Author | Year | Number of patients | Study objective | Inclusion criteria | Study duration | Complications | PSA | Functional outcomes | Oncologic outcomes |
|---|---|---|---|---|---|---|---|---|---|
Napoli et al. [17] | 2013 | N = 5 | Proof of principle [treat and resect] study [single center] | -Unifocal, biopsy-proven PCa on mpMRI GG1: 3 (60%) GG2: 2 (40%) | Radical prostatectomy in 7–14 days (mean 9 days) | -No technical difficulties related to MRgFUS ablation during surgery | n/a | n/a | -Extensive coagulative necrosis at ablation site -No residual viable tumor in the ablation area or margins |
Tay et al. [21] | 2017 | N = 14 | Phase I Safety and efficacy study [single center] | - Age 50–75 years -GG1 -≤ cT2a -Index tumor ≤10cc -Maximum of two positive zones on biopsy or MR-identifiable tumors or a combination of the two | 2 years | 7 Clavien-Dindo grade 1–2 complications -1/7 acute urinary retention -1/7 epididymo-orchitis -5/7 self-limiting hematuria | Median decrease by 2.9 ng/mL at 6 months | No significant change in urinary symptom and sexual function scores at 2 years | At 6 months: -6 patients with ≥GG1 [1 with ≥GG2] At 24 months: -8/12 patients in-field/adjacent recurrence [3 with ≥GG2] |
Ghai et al. [18] | 2018 | N = 8 (10 lesions) | Phase I safety and efficacy study [single center] | PSA ≤ 10 ng/mL -≤cT2a -≤GG3 GG1: 6 (60%) GG2: 2 (20%) GG3: 2 (20%) | 6 months | Not reported | Mean decrease by 1.66 ng/mL at 6 months | Quality of life parameters stable between baseline and 6 months in 6/8 patients | At 6 months: -3/10 sites GG1 disease -1/10 site GG4 disease |
Ehdaie et al. [22] | 2022 | N = 101 | Phase II safety, functional and oncological outcomes [multi-center] | -Age >50 years -Unilateral, organ-confined, visible on mpMRI -GG2 or GG3 -stage ≤ T2 -PSA ≤ 20 ng/mL | 2 years | -1 patient with urinary tract infection | Mean decrease by 2.6 ng/mL at 24 months | -IIEF-15 score decreased [-3.5] at 24 months -No significant change in IPSS scores | At 24 months: -78/89 (88%) free of csPCa (≥GG2) at the treated site -59/98 (60%) in the entire gland |
Ghai et al. [24] | 2024 | N = 44 | Phase II safety, functional and oncological outcomes [single center] | -Age ≥50 years -Unifocal, organ-confined, <20 mm max length, -GG2 or GG3 -PSA ≤ 20 ng/mL -Life expectancy >10 years | 2 years | -1 patient with persistent pelvic pain | Median decrease by 3.7 ng/ml at 24 months | -No significant decline in IIEF-15 and IPSS scores | At 24 months: -39/43 (91%) free of csPCa (≥GG2) at the treated area -36/43 (84%) in entire gland |
