Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue in Patients with Localized Prostate Cancer: A Prospective Phase 1 Clinical Trial

被引:70
作者
Chin, Joseph L. [1 ]
Billia, Michele [1 ]
Relle, James [2 ]
Roethke, Matthias C. [3 ]
Popeneciu, Ionel V. [4 ]
Kuru, Timur H. [4 ]
Hatiboglu, Gencay [4 ]
Mueller-Wolf, Maya B. [3 ]
Motsch, Johann [4 ]
Romagnoli, Cesare [1 ]
Kassam, Zahra [1 ]
Harle, Christopher C. [1 ]
Hafron, Jason [2 ]
Nandalur, Kiran R. [2 ]
Chronik, Blaine A. [1 ]
Burtnyk, Mathieu [5 ]
Schlemmer, Heinz-Peter [3 ]
Pahernik, Sascha [4 ]
机构
[1] Univ Western Ontario, London Hlth Sci Ctr, E2-650,800 Commissioners Rd East, London, ON N6A 5W9, Canada
[2] Beaumont Hlth Syst, Royal Oak, MI USA
[3] German Canc Res Ctr, Heidelberg, Germany
[4] Univ Heidelberg Hosp, Heidelberg, Germany
[5] Profound Med Inc, Toronto, ON, Canada
关键词
Prostate cancer; Ultrasound ablation; Magnetic resonance imaging; Image-guided intervention; Minimally invasive; Transurethral; Phase 1 clinical trial; GEL PHANTOMS; ACTIVE SURVEILLANCE; THERMAL THERAPY; FOCAL THERAPY; MANAGEMENT; SIMULATIONS; OUTCOMES; MEN;
D O I
10.1016/j.eururo.2015.12.029
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
Background: Magnetic resonance imaging-guided transurethral ultrasound ablation (MRI-TULSA) is a novel minimally invasive technology for ablating prostate tissue, potentially offering good disease control of localized cancer and low morbidity. Objective: To determine the clinical safety and feasibility of MRI-TULSA for whole-gland prostate ablation in a primary treatment setting of localized prostate cancer (PCa). Design, setting, and participants: A single-arm prospective phase 1 study was performed at three tertiary referral centers in Canada, Germany, and the United States. Thirty patients (median age: 69 yr; interquartile range [IQR]: 67-71 yr) with biopsy-proven low-risk (80%)and intermediate-risk (20%) PCa were treated and followed for 12 mo. Intervention: MRI-TULSA treatment was delivered with the therapeutic intent of conservative whole-gland ablation including 3-mm safety margins and 10% residual viable prostate expected around the capsule. Outcome measurements and statistical analysis: Primary end points were safety (adverse events) and feasibility (technical accuracy and precision of conformal thermal ablation). Exploratory outcomes included quality of life, prostate-specific antigen (PSA), and biopsy at 12 mo. Results and limitations: Median treatment time was 36 min (IQR: 26-44) and prostate volume was 44 ml (IQR: 38-48). Spatial control of thermal ablation was +/-1.3 mmon MRI thermometry. Common Terminology Criteria for Adverse Events included hematuria (43% grade [G] 1; 6.7% G2), urinary tract infections (33% G2), acute urinary retention (10% G1; 17% G2), and epididymitis (3.3% G3). There were no rectal injuries. Median pretreatment International Prostate Symptom Score 8 (IQR: 5-13) returned to 6 (IQR: 4-10) at 3 mo (mean change: -2; 95% confidence interval [CI], -4 to 1). Median pretreatment International Index of Erectile Function 13 (IQR: 6-28) recovered to 13 (IQR: 5-25) at 12 mo (mean change: -1; 95% CI, -5 to 3). Median PSA decreased 87% at 1 mo and was stable at 0.8 ng/ml (IQR: 0.6-1.1) to 12 mo. Positive biopsies showed 61% reduction in total cancer length, clinically significant disease in 9 of 29 patients (31%; 95% CI, 15-51), and any disease in 16 of 29 patients (55%; 95% CI, 36-74). Conclusions: MRI-TULSA was feasible, safe, and technically precise for whole-gland prostate ablation in patients with localized PCa. Phase 1 data are sufficiently compelling to study MRI-TULSA further in a larger prospective trial with reduced safety margins. Patient summary: We used magnetic resonance imaging-guided transurethral ultrasound to heat and ablate the prostate in men with prostate cancer. We showed that the treatment can be targeted within a narrow range (1 mm) and has a well-tolerated side effect profile. A larger study is under way. Trial registration: NCT01686958, DRKS00005311. (C) 2016 Published by Elsevier B.V. on behalf of European Association of Urology.
引用
收藏
页码:447 / 455
页数:9
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