OBJECTIVES: To determine whether combining short-term neoadjuvant androgen 
deprivation therapy (NADT) with high-intensity focused ultrasound (HIFU) had a 
significant benefit in a large population of men with nonmetastatic prostate 
cancer (CaP).
METHODS: We evaluated the records of 530 patients whose prostate-specific 
antigen (PSA) level at diagnosis was 30 ng/mL or less and whose follow-up period 
was not less than 12 months, at seven investigational sites. Two hundred seventy 
patients had received NADT (within 6 months), and 260 had not. The primary 
outcome measure was disease-free survival according to the combined criteria 
satisfying the Phoenix definition (less than nadir + 2), negative prostate 
biopsy, and no findings of distant metastasis after the last HIFU treatment. The 
significance of the differences of values or the distributions of each parameter 
between two groups was evaluated with a Mann-Whitney U test, unpaired t test, or 
chi-square test, and a multivariate Cox proportional hazards model was used to 
evaluate the prognostic relevance of preoperative parameters.
RESULTS: Statistical analyses showed that the NADT group had worse disease 
(higher PSA and risk group) than the HIFU-only group. Variables shown by 
multivariate analyses to be significant prognostic parameters were pretreatment 
PSA level, clinical stage, and no use of NADT. Short-term NADT significantly 
improved the 3-year disease-free survival rate of patients with 
intermediate-risk and high-risk CaP. During follow-up the frequencies of 
complications did not differ significantly with or without NADT.
CONCLUSIONS: Our retrospective study suggests that combining short-term NADT 
with HIFU treatment is of significant clinical benefit to intermediate-risk and 
high-risk CaP patients without increasing the likelihood of complications.