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Plenary: Next Frontier, Sunday, Afternoon Session
Presentation Authors: Scott Eggener*, Chicago, IL, David Penson, Nashville, TN, Christian Pavlovich, Baltimore, MD, Joseph Chin, London, Canada, Steven S. Raman, Santa Monica, CA, Michael Koch, Indianapolis, IN, Jurgen Futterer, Nijmegen, Netherlands, James Relle, Royal Oak, MI, Gencay Hatiboglu, Heidelberg, Germany, Aytekin Oto, Chicago, IL, Yair Lotan, Dallas, TX, Axel Heidenreich, Cologne, Germany, Marc Serrallach, Barcelona, Spain, Allan Pantuck, Santa Monica, CA, Sandeep S. Arora, Nashville, TN, Katarzyna Macura, Baltimore, MD, Temel Tirkes, Indianapolis, IN, Daniel Costa, Dallas, TX, Gregory Zagaja, Chicago, IL, Thorsten Persigehl, Cologne, Germany, J. P. Michiel Sedelaar, Nijmegen, Netherlands, William Li, Robert Staruch, Mathieu Burtnyk, Mississauga, Canada, David Bonekamp, Heidelberg, Germany, Masoom Haider, Laurence Klotz, Toronto, Canada
Introduction: MRI-guided transurethral ultrasound ablation (TULSA) is a novel minimally-invasive procedure for customized prostate ablation. We report one-year outcomes from the TULSA-PRO Ablation Clinical Trial (TACT).
Methods: The study enrolled 115 men with organ-confined prostate cancer (≤T2b, PSA ≤15 ng/ml, Gleason Grade Group 1-2) across 13 centers in USA, Europe, and Canada. Treatment intent was whole-gland ablation with sparing of the urethra and urinary sphincter. The primary safety endpoint was frequency and severity of adverse events (CTCAE). The primary efficacy endpoint was proportion of men achieving a PSA reduction ≥ 75%. Secondary endpoints included one-year 10-core biopsy, prostate volume reduction, and quality of life (IPSS, IIEF-15, EPIC).
Results: Median (IQR) age was 65 (59-69) years and PSA 6.3 (4.6-7.9) ng/ml. Pre-treatment, 72 of 115 (63%) men had Grade Group 2 (GG2) and 77 (67%) had NCCN intermediate-risk disease. Median (IQR) treatment delivery time was 51 (39-66) min for targeted prostate volumes of 40 (32-50) cc with 98% (95-99%) thermal coverage of target volume and spatial ablation precision of ±1.4 mm on MRI thermometry. Grade 3 adverse events occurred in 9 (8%) men, including infections (4%), urethral stricture (2%), urinary retention (2%), urethral calculus and pain (1%), and urinoma (1%), all resolved. There were no rectal injuries or Grade ≥ 4 events. The primary endpoint of PSA reduction ≥75% was achieved in 110 of 115 (96%), with median (IQR) PSA reduction of 95% (91-98%) and nadir of 0.34 (0.12-0.56) ng/ml. Median perfused prostate volume decreased from 41 to 4 cc. Among 68 men with pre-treatment intermediate-risk GG2, 54 (79%) were free of GG2 disease on one-year biopsy. Of 111 men with one-year biopsy data, 72 (65%) had no evidence of any cancer. Of 112 men with one-year continence data, 1% were incontinent (>1 pad/day), daily leakage increased in 4%, and 8% wore a pad. Median IPSS was unchanged at one year, from 6 to 6 (n=105). At one year, 20% of patients had Grade 2 erectile dysfunction, median (IQR) change in IIEF-5 was -3 (-13 to 0, n=105), and 69 of 92 (75%) maintained erections sufficient for penetration (IIEF Q2 ≥ 2). Multivariate predictors of GG2 at one year included presence of intraprostatic calcifications at screening, MRI thermal coverage of target volume, and PIRADS ≥ 3 lesion at one-year post-treatment MRI (p < 0.05).
Conclusions: The TACT pivotal study of MRI-guided transurethral ultrasound whole-gland ablation (TULSA) in men with localized prostate cancer met its primary endpoint of ≥ 75% PSA reduction in 96% of patients with low rates of severe toxicity and residual GG2 disease.
Source of Funding: Profound Medical