Cancer control outcomes following focal therapy using high-intensity focused ultrasound in 1379 men with nonmetastatic prostate cancer: a multi-institute 15-year experience

Reddy, Deepika, Peters, Max, Shah, Taimur T, van Son, Marieke, Tanaka, Mariana Bertoncelli, Huber, Philipp M, Lomas, Derek, Rakauskas, Arnas, Miah, Saiful, Eldred-Evans, David, Guillaumier, Stephanie, Hosking-Jervis, Feargus, Engle, Ryan, Dudderidge, Tim, Hindley, Richard G, Emara, Amr, Nigam, Raj, McCartan, Neil, Valerio, Massimo, Afzal, Naveed, Lewi, Henry, Orczyk, Clement, Ogden, Chris, Shergill, Iqbal, Persad, Raj, Virdi, Jaspal, Moore, Caroline M, Arya, Manit, Winkler, Mathias, Emberton, Mark and Ahmed, Hashim U (2022) Cancer control outcomes following focal therapy using high-intensity focused ultrasound in 1379 men with nonmetastatic prostate cancer: a multi-institute 15-year experience. European Urology, 81 (4), 407-413. (doi:10.1016/j.eururo.2022.01.005).

Abstract

Background: Focal therapy aims to treat areas of cancer to confer oncological control whilst reducing treatment-related functional detriment. Objective: To report oncological outcomes and adverse events following focal high-intensity focused ultrasound (HIFU) for treating nonmetastatic prostate cancer. Design, setting, and participants: An analysis of 1379 patients with ≥6 mo of follow-up prospectively recorded in the HIFU Evaluation and Assessment of Treatment (HEAT) registry from 13 UK centres (2005–2020) was conducted. Five or more years of follow-up was available for 325 (24%) patients. Focal HIFU therapy used a transrectal ultrasound-guided device (Sonablate; Sonacare Inc., Charlotte, NC, USA). Outcome measurements and statistical analysis: Failure-free survival (FFS) was primarily defined as avoidance of no evidence of disease to require salvage whole-gland or systemic treatment, or metastases or prostate cancer–specific mortality. Differences in FFS between D'Amico risk groups were determined using a log-rank analysis. Adverse events were reported using Clavien-Dindo classification. Results and limitations: The median (interquartile range) age was 66 (60–71) yr and prostate-specific antigen was 6.9 (4.9–9.4) ng/ml with D'Amico intermediate risk in 65% (896/1379) and high risk in 28% (386/1379). The overall median follow-up was 32 (17–58) mo; for those with ≥5 yr of follow-up, it was 82 (72–94). A total of 252 patients had repeat focal treatment due to residual or recurrent cancer; overall 92 patients required salvage whole-gland treatment. Kaplan-Meier 7-yr FFS was 69% (64–74%). Seven-year FFS in intermediate- and high-risk cancers was 68% (95% confidence interval [CI] 62–75%) and 65% (95% CI 56–74%; p = 0.3). Clavien-Dindo >2 adverse events occurred in 0.5% (7/1379). The median 10-yr follow-up is lacking. Conclusions: Focal HIFU in carefully selected patients with clinically significant prostate cancer, with six and three of ten patients having, respectively, intermediate- and high-risk cancer, has good cancer control in the medium term. Patient summary: Focal high-intensity focused ultrasound treatment to areas of prostate with cancer can provide an alternative to treating the whole prostate. This treatment modality has good medium-term cancer control over 7 yr, although 10-yr data are not yet available.

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