Up to a third of patients with localized prostate cancer have unilateral disease that may be suitable for partial treatment with hemiablation.
To evaluate the ability of high intensity focused ultrasound (HIFU) to achieve local control of the tumor in patients with unilateral localized prostate cancer.
Design, setting, and participants
The French Urological Association initiated a prospective IDEAL multi-institutional study (2009–2015), to evaluate HIFU-hemiablation as a primary treatment.
Multiparametric magnetic resonance imaging and biopsy were used for unilateral cancer diagnosis and control, and HIFU-hemiablation.
Outcome measurements and statistical analysis
Primary: absence of clinically significant cancer (CSC) on control biopsy at 1 yr (CSC: Gleason score ≥ 7 or cancer core length > 3 mm regardless of grade or > 2 positive cores). Secondary: presence of any cancer on biopsy, biochemical response, radical treatment free survival, adverse events, continence (no pad), erectile function (International Index of Erectile Function-5 ≥ 16), and quality of life (European Organization for Research and Treatment of Cancer QLQ-C28) questionnaires.
Results and limitations
One hundred and eleven patients were treated (mean age: 64.8 yr [standard deviation 6.2]; mean prostate-specific antigen: 6.2 ng/ml [standard deviation 2.6]; 68% low risk, 32% intermediate risk). Of the 101 patients with control biopsy, 96 (95%) and 94 (93%) had no CSC in the treated and contralateral lobes, respectively. Mean prostate-specific antigen at 2 yr was 2.3 ng/ml (standard deviation 1.7). The radical treatment-free survival rate at 2 years was 89% (radical treatments: six radical prostatectomies, three radiotherapies, and two HIFU). Adverse events were Grade 3 in 13%. At 12 mo continence and erectile functions were preserved in 97% and 78%. No significant decrease in quality of life score was observed at 12 mo. One limitation is the number of low-risk patients included in this study.
At 1 yr, HIFU-hemiablation was efficient with 95% absence of clinically significant cancer associated with low morbidity and preservation of quality of life. Radical treatment-free survival rate was 89% at 2 yr.
This report shows that high intensity focused ultrasound half-gland treatment of unilateral prostate cancer provides promising results with high cancer control and low morbidity.
Keywords: Prostate cancer, Focal therapy, High-intensity focused ultrasound, Hemiablation, Prospective trial.
a Department of Urology, Rangueil University Hospital, Toulouse, France
b Department of Urology and Transplantation Surgery, Edouard Herriot Hospital, Lyon, France
c Department of Urology, Université de Lyon, Lyon, France
d INSERM Unit 1032, LabTau, Université de Lyon, Lyon, France
e Hospices Civils de Lyon, Service de Biostatistiques, Lyon, France
f Department of Urology, Huriez Hospital, Lille University, France
g Department of Urology, CHU Pellegrin, Bordeaux, France
h Department of Urology, General Hospital of Chambéry, Chambéry, France
i Department of Urology, Pasteur Hospital, Colmar, France
j Department of Urology, University Hospital of Rouen, Rouen, France
k Department of Urology and Transplantation, South Hospital of Amiens, Amiens, France
l Department of Surgical Urology, North Hospital of Marseille, Marseille, France
m Department of Urology, Saint-Michel Clinic, Toulon, France
n Department of Radiology, Edouard Herriot Hospital, Lyon, France
Corresponding author. Department of Urology, Centre Hospitalier Universitaire de Rangueil, 1, Avenue Jean Poulhès TSA 50032, Toulouse, 31059 Cedex 9, France. Tel. +33 5 61 32 32 40; Fax: +33 5 61 32 32 30.
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© 2016 European Association of Urology, Published by Elsevier B.V.