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PSA nadir and PSA flare are the predictors of biochemical failure after High-Intensity Focused Ultrasound treatment of localized prostate cancer

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Sources of Funding: none

Introduction

High-Intensity Focused Ultrasound (HIFU) is an emerging treatment for localized prostate cancer patients. HIFU is a noninvasive technique that induces coagulative necrosis in tumors without surgical exposure or insertion of instruments into the lesion. We evaluated the association between clinical outcomes and biochemical failure (BCR).

Methods

From June 2006 to November 2014, 259 consecutive patients with T1-2 prostate cancer were treated with Sonablate? (SB) devices. After HIFU, prostate-specific antigen (PSA) was measured every 3 months. BCR was defined according to the Stuttgart definition (a rise of 1.2 ng/ml or more above the nadir PSA). Serum PSA level was increased rapidly after HIFU. Then, PSA flare was determined an increase of 3.0 ng/ml with a spontaneous return to the pre-flare level or lower. Predictors for BCR was identified using the Cox-proportional hazard method.

Results

A total of 259 patients with a median age of 67.6 years were followed for median duration of 59 months. Mean pretreatment PSA was 9.6 ng/ml. Mean pretreatment prostate volume was 28.7ml. Stratification according to D’Amico’s risk group was low, intermediate, high in 23.6%, 30.5%, 45.9% of patients, respectively. Neoadjuvant hormone therapy was administered in 45.1% of patients. Transurethral resection of prostate (TURP) at the time of HIFU was performed in 34.4% of patients. Mean PSA nadir was 0.3 ? 0.8 ng/ml with 77.6% reaching nadir of ? 0.3 ng/ml. The overall survival rate at 5 year was 99.6%. The 3- and 5- BCR free survival rates were 72.3-62.6%, 89.1-78.1%, 72.7-65.0%, 62.6-51.1% for all patients, low- intermediate-, and high risk patients. 44.1% of patients had urinary structure, 29.7% of patients had self-resolving lower urinary tract syndrome (LUTS). Cox multivariate analysis revealed Preoperative PSA (PSA cut off = 10 ng/ml: Hazard ratio (HR) = 2.369, 95% CI 1.518–3.735, p<0.001), D’Amico risk group (Low & intermediate vs high: HR = 2.359, 95% CI 1.066-3.086, p=0.028), PSA nadir (PSA cut off = 0.3 ng/ml: HR = 3.248, 95% CI 1.943-5.427, p<0.001), and PSA flare (PSA cut off = 3.0ng/ml: HR = 2.063, 95% CI 1.014-4.194, p=0.046) were a predictor for BCR.

Conclusions

HIFU represents an effective, minimally invasive treatment for prostate cancer. The PSA nadir and PSA flare correlate significantly with BCR, and can be applied in daily clinical practice.

Funding

none

Authors
Naokazu Ibuki
Teruo Inamoto
Yudai Nishimoto
Kiyoshi Takahara
Toshikazu Watsuji
Haruhito Azuma
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