High-intensity focused ultrasound safe, effective in radiocurrent prostate cancer
Treatment of radiocurrent prostate cancer with whole gland high-intensity focused ultrasound is reasonably safe and effective, according to a recent study.
“The rate of complications, which are potentially severe, was acceptable, especially considering the advanced, refractory nature of the disease and the limited treatment options,” researchers said.
A total of 100 men (mean age 70 years) were treated, of whom 78 completed the 12-month biopsy, which was negative in 63 (81 percent).
The median Gleason score was 7 and mean prostate-specific antigen was 4.9 ng/ml (range, 0.4‒14). Fifty men achieved the 1-year endpoint of a prostate-specific antigen nadir of ≤0.5 ng/ml and negative biopsy. Mean prostate-specific antigen at 2 years was 1.1 ng/ml (range, 0.1‒17) in 22 patients during post-trial follow-up.
Ninety-one men developed adverse events (AEs) through 12 months (grade 1 in 67; grade 2 in 80; and grade 3 in 20). Treatment-related grade 3 AEs included rectal fistulas (n=5; surgery required in 3), osteitis pubis (n=3), and haematuria (intervention required in 3). Treatment-related grade 3 AEs developed early in the trial and were potentially linked to operator experience.
No life-threatening AEs or treatment-related deaths were reported.
In this study, men (n=100) with clinically localized recurrent prostate cancer at least 2 years following external beam radiation therapy underwent whole gland high intensity focused ultrasound in an open-label trial from 2009 to 2012.
The combination of a prostate-specific antigen nadir of ≤0.5 ng/ml and negative biopsy at 12 months was the primary endpoint. Researchers administered validated questionnaires to monitor changes in urinary and sexual function.