A recent French trial compared the efficacy of high-intensity focused ultrasound (HIFU) and radical prostatectomy (RP) as primary treatments for localized prostate cancer. The study, conducted by Pascal Rischmann, MD, PhD, of Toulouse Academic Hospital, found that at a follow-up of 30 months, patients treated with HIFU had a significantly higher salvage treatment-free survival rate compared to those who underwent RP. Moreover, patients who received HIFU also reported better functional results in terms of urinary continence and erectile function.
Main Study Findings
The HIFI study, a non-inferiority, prospective, non-randomized study, was performed in 46 centers across France from April 2015 through September 2019. A total of 3,328 patients were included in the trial, with 1,967 patients receiving HIFU treatment and 1,361 undergoing RP. Patients eligible for the study had low- or intermediate-risk prostate cancer and met specific criteria related to PSA levels, Gleason scores, and clinical stage. HIFU was delivered using the Focal One device, with treatment limited to 70% of the prostate gland.
Overall Survival and Complications
The study found that the overall survival rate was high in both the HIFU and RP arms, with no significant difference between the two groups after adjusting for age. Cancer-specific survival was 100% in both arms, and no deaths were attributed to treatment. Complications greater than IIIa were reported in a small percentage of patients in both treatment arms, with slightly higher rates in the RP group.
Regarding functional results, patients who underwent HIFU reported lower rates of urinary incontinence and erectile dysfunction compared to those who underwent RP. Stress incontinence scores were significantly lower in the HIFU group, with a higher percentage of patients reporting normal to moderately impaired erections at the 30-month follow-up. Quality of life scores were comparable between the two groups, despite the difference in age.
The study suggests that HIFU is non-inferior to RP as a primary treatment for localized prostate cancer. Patients treated with HIFU demonstrated higher salvage treatment-free survival rates and better functional outcomes in terms of urinary continence and erectile function. The findings of this study provide valuable insights into the potential benefits of HIFU in the management of localized prostate cancer. Further research and longer follow-up periods are needed to confirm these results and assess the long-term outcomes of HIFU treatment.