SAN ANTONIO — A comparison of high-intensity focused ultrasound (HIFU) and radical prostatectomy (RP) found that HIFU was non-inferior to surgery as primary treatment for localized prostate cancer, according to a French trial.
At a follow-up of 30 months, patients treated with HIFU had a significantly higher salvage treatment-free survival rate than patients who underwent RP (89.8% vs 86.2%, HR 0.76, 95% CI 0.61-0.96, P=0.008), reported Pascal Rischmann, MD, PhD, of Toulouse Academic Hospital in Toulouse.
Results were similar when adjusted for age and other covariates at baseline, including BMI, American Society of Anesthesiologists physical status score, Prostate volume, PSA level, and grade group (HR 0.71, 95% CI 0.52-0.97, P=0.03).
Moreover, patients treated with HIFU had better functional results regarding urinary continence and erectile function, Rischmann observed.
This is the first prospective study comparing HIFU and RP as a primary treatment for localized prostate cancer grade group 1 and 2, Rischmann said during a plenary session at the American Urological Association annual meeting. “Salvage treatment-free survival after HIFU was not inferior compared to radical prostatectomy.”
The HIFI study was a non-inferiority, prospective, non-randomized study performed in 46 centers across France from April 2015 through September 2019. The trial included a total of 3,328 patients, 1,967 of whom were treated with HIFU and 1,361 underwent RP.
Patients were eligible for the study if they had low- or intermediate-risk prostate cancer (PSA 1.
Overall survival was 97.7% in the HIFU arm and 99.5% in the RP arm, but there was no significant difference between the two groups after adjusting for age (HR 2.53, 95% CI 0.95-6.73, P=0.064).
Cancer-specific survival was 100% in both arms, and no deaths were attributed to treatment.
Of those patients in the HIFU arm, 10% eventually underwent salvage treatment, 5% underwent second HIFU, and 2% went on active surveillance. In the RP arm, 13% underwent salvage treatment and 2% went on active surveillance.
Regarding safety, complications greater than IIIa were reported in 2.7% and 2.1% of patients after HIFU and RP, respectively.
As for functional results, urinary incontinence and erectile dysfunction “were significantly lower after HIFU,” Rischmann reported.
Specifically, at 12 months, 64% of patients who underwent HIFU had a stress incontinence score of 0 (indicating the patient had no or very mild urinary continence symptoms) compared with 48% of patients in the RP group (risk ratio 0.76, 95% CI 0.70-0.83, P
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