UMIN-CTR Clinical Trial

We treated 90 men (median age: 70 years; median PSA level: 7.26 ng/ml). Catheterization was performed within 24 hours after the treatment in all patients. Biochemical disease-free rate was 92.2% during 21 months follow-up when use of Phoenix ASTRO definition. In follow-up biopsy, significant cancer was detected in 8.9% of the patients in un-treated areas. Urinary functions were preserved preoperative levels at 3 or 6 months. Rates of ED and ejaculation who had the functions were 86% and 70%, respectively.

Median age 70 years old (range: 39 to 85 years
Median PSA level was 7.26 ng/ml (range: 2.48 to 19.95 ng/ml)
Risk classifications were low: n= 31, intermediate: n=44, and high: n=15

Of the 482 patients who were received MRI-TRUS fusion image-guided biopsy and 12-cores transperineal systematic biopsy, 178 patients were satisfied the inclusion criteria. After the informed consent, patients who had the lesion includes urethra and bilateral PZ close to NVB, the severe anal stricture, and difficulty to understand what is the focal therapy, were excluded from the study. The focal therapy was performed for the 90 patients, and these patients were followed up at least 1 year.

4 patient (4.4%) suffered Grade 2 (1 case) and Grade3 (3 cases) urinary tract infection at 1 month after the treatment
3 patients (3.3%) suffered Grade 3 urethral strictures at 3 months after the treatment
No patients suffered incontinence and recto-urethral fistula. 
Among the 43 patients who had erectile function without phosphodiesterase-5 inhibitor (PDE-5 inhibitor) before treatment, post-treatment erectile dysfunction rates without PDE-5 inhibitor was 86% (n=37) at 12 months after the treatment. 
Among the 43 patients who had erectile function, ejaculation was preserved in 70% (n=30) at 12 months post-treatment.