A Multicentre Study of 5-year Outcomes Following Focal Therapy in Treating Clinically Significant Nonmetastatic Prostate Cancer

Stephanie Guillaumier,Manit Arya,Richard G Hindley,Jaspal Virdi,Tim Dudderidge,Hashim U Ahmed,Raj Persad,Neil Mccartan,Mathias Winkler,Max Peters,Raj Nigam,Caroline M Moore,Chris Ogden,Jan Van Der Meulen,Mark Emberton,Naveed Afzal,Henry Lewi,Karishma Shah,Susan C Charman ,Feargus Hosking‐Jervis

doi:10.1016/j.eururo.2018.06.006

Abstract

BackgroundClinically significant nonmetastatic prostate cancer (PCa) is currently treated using whole-gland therapy. This approach is effective but can have urinary, sexual, and rectal side effects. ObjectiveTo report on 5-yr PCa control following focal high-intensity focused ultrasound (HIFU) therapy to treat individual areas of cancer within the prostate. Design, setting, and participantsThis was a prospective study of 625 consecutive patients with nonmetastatic clinically significant PCa undergoing focal HIFU therapy (Sonablate) in secondary care centres between January 1, 2006 and December 31, 2015. A minimum of 6-mo follow-up was available for599 patients. Intermediate- or high-risk PCa was found in 505 patients (84%). InterventionDisease was localised using multiparametric magnetic resonance imaging (mpMRI) combined with targeted and systematic biopsies, or transperineal mapping biopsies. Areas of significant disease were treated. Follow-up included prostate-specific antigen (PSA) measurement, mpMRI, and biopsies. Outcome measurements and statistical analysisThe primary endpoint, failure-free survival (FFS), was defined as freedom from radical or systemic therapy, metastases, and cancer-specific mortality. Results and limitationsThe median follow-up was 56 mo (interquartile range [IQR] 35–70). The median age was 65 yr (IQR 61–71) and median preoperative PSA was 7.2 ng/ml (IQR 5.2–10.0). FFS was 99% (95% confidence interval [CI] 98–100%) at 1 yr, 92% (95% CI 90–95%) at 3 yr, and 88% (95% 85–91%) at 5 yr. For the whole patient cohort, metastasis-free, cancer-specific, and overall survival at 5 yr was 98% (95% CI 97–99%), 100%, and 99% (95% CI 97–100%), respectively. Among patients who returned validated questionnaires, 241/247 (98%) achieved complete pad-free urinary continence and none required more than 1 pad/d. Limitations include the lack of long-term follow-up. ConclusionsFocal therapy for select patients with clinically significant nonmetastatic prostate cancer is effective in the medium term and has a low probability of side effects. Patient summaryIn this multicentre study of 625 patients undergoing focal therapy using high-intensity focused ultrasound (HIFU), failure-free survival, metastasis-free survival, cancer-specific survival, and overall survival were 88%, 98%, 100%, and 99%, respectively. Urinary incontinence (any pad use) was 2%. Focal HIFU therapy for patients with clinically significant prostate cancer that has not spread has a low probability of side effects and is effective at 5 yr.

Highlights

The therapeutic approach to nonmetastatic prostate cancer is an outlier compared to strategies for other solid organ cancers
While current trends demonstrate that radical therapy is increasingly used among the patients most likely to benefit from treatment with respect to better cancerspecific survival [4], there is still a need to reduce treatmentrelated side effects, as the survival benefit conferred by radical treatment is often seen over 10–15 yr when compared to a strategy of active monitoring [5]
We report on medium-term cancer control outcomes in a large multicentre patient cohort with clinically significant nonmetastatic prostate cancer treated with focal therapy using high-intensity focused ultrasound (HIFU)

Summary

Introduction

The therapeutic approach to nonmetastatic prostate cancer is an outlier compared to strategies for other solid organ cancers. The aim of focal therapy is to reduce side effects and maintain cancer control by targeting areas of known cancer in a similar approach to that for other solid organ cancers [6,7,8]. This concept of tissue preservation has come about through improvements in disease localisation using multiparametric magnetic resonance imaging (mpMRI) and mapping biopsy techniques [9]. Significant nonmetastatic prostate cancer (PCa) is currently treated using whole-gland therapy This approach is effective but can have urinary, sexual, and rectal side effects. For the whole patient cohort, metastasisfree, cancer-specific, and overall survival at 5 yr was 98% (95% CI 97–99%), 100%, and 99%

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