Single application of high-intensity focused ultrasound as a first-line therapy for clinically localized prostate cancer: 5-year outcomes.

UNLABELLED

Study Type--Therapy (case series) Level of Evidence 4. What's known on the subject? and What does the study add? High-intensity focused ultrasound (HIFU) therapy has been proposed for the treatment of localized prostate cancer (PCa) for all risk levels of tumour recurrence. The study adds data on the efficacy of a single HIFU application in the treatment of PCa with different risks of recurrence. Durable cancer control was achieved in 81.7% of patients with low-risk disease, with rates of efficacy declining in intermediate- and high-risk tumours. The data suggest that the principal domain for minimal invasive HIFU should be low-risk disease.

OBJECTIVE

• To report cancer control results after a single application of high-intensity focused ultrasonography (HIFU) in patients with localized prostate cancer (PCa), stratified by tumour recurrence risk according to D'Amico risk classification.

PATIENTS AND METHODS

• In a retrospective single-centre study, we analysed the outcomes of patients with localized PCa who were treated with curative intent between December 2002 and October 2006 using an Ablatherm HIFU device (EDAP-TMS, France). • Transurethral resection of the prostate or adenomectomy were performed before HIFU to downsize large prostate glands. • Oncological failure was determined by the occurrence of biochemical relapse, positive biopsy and/or metastasis. Biochemical relapse was defined as a PSA nadir +1.2 ng/mL (Stuttgart definition), or as a rise in PSA level to ≥ 0.5 ng/mL if PSA doubling time was ≤ 6 months. Kaplan-Meier analysis was performed for survival estimates.

RESULTS

• A total of 191 consecutive patients were included in the study. The median (range) patient age was 69.7 (51-82) years, and 38, 34 and 28% of these patients were in the low-, intermediate- and high-risk groups, respectively. • The median (range) follow-up was 52.8 (0.2-79.8) months. • At 5 years, overall and cancer-specific survival rates were 86.3% and 98.4%, respectively. • Stratified by risk group, negative biopsy rates were 84.2%, 63.6%, and 67.5% (P = 0.032), 5-year biochemical-free survival rates were 84.8%, 64.9% and 54.9% (P< 0.01), and 5-year disease-free survival rates were 81.7%, 53.2% and 51.2% (P < 0.01), respectively.

CONCLUSION

• Single-session HIFU is recommended as a curative approach in elderly patients with low-risk PCa. Patients at higher risk of tumour progression should be counselled regarding the likely need for salvage therapy, including repeat HIFU.