PD17-02 PIVOTAL TRIAL OF MRI-GUIDED TRANSURETHRAL ULTRASOUND ABLATION IN MEN WITH LOCALIZED PROSTATE CANCER: TWO-YEAR FOLLOW-UP

Abstract

INTRODUCTION AND OBJECTIVE: MRI-guided transurethral ultrasound ablation (TULSA) is a novel minimally-invasive procedure for prostate ablation. We report two-year outcomes from the pivotal TULSA-PRO Ablation Clinical Trial (TACT). METHOD(S): The study enrolled 115 men with organ-confined prostate cancer ( =2 (GG2+) disease in 72/ 115 men (63%). Targeted prostate volumes of 40 (32-50) cc were ablated in 51 (39-66) min, with 98% thermal coverage and +/-1.4 mm spatial precision on MRI thermometry. Grade 3 adverse events occurred in 9 (8%) men (all resolved before one year), with no rectal injuries or Grade >= 4 events. At one year MRI and biopsy, median prostate volume decreased from 37 to 3 cc, GG2 disease was eliminated in 54/68 (79%) men, and 72/111 (65%) had no evidence of any cancer. Two-year PSA and QoL are currently available for 48/115 patients. Median PSA decreased 95% to a nadir of 0.30 ng/ml, stable from 0.53 ng/ml at one year to 0.68 ng/ml (n=48) at 2 years. Median IPSS was unchanged from 7 to 6 at one year and 5 (n=47) at two years. Moderate urinary incontinence (Grade 2, pads) was reported by 3 patients (2.6%) at one year, with no new incontinence at two years. The rate of moderate erectile dysfunction (Grade 2, responding to PDE5) was 23% at one year, with one new onset at two years. Median change in IIEF-5 recovered from -3 at one year to -1 (n=46) at two years. Erections sufficient for penetration (IIEF Q2 >= 2) were maintained by 69/92 (75%) at one year, and for the patient subset with two-year follow-up, by 25/37 (68%) and 23/37 (62%) at one and two years, respectively. Three men whose one-year biopsy indicated incomplete ablation underwent uncomplicated salvage radical prostatectomy. CONCLUSION(S): With two-year follow-up, the TACT pivotal study of MRI-guided transurethral ultrasound ablation (TULSA) in men with localized prostate cancer showed effective disease control in most patients with low toxicity and stable quality of life.