Lba-26 pivotal Trial of Mri-Guided Transurethral Ultrasound Ablation in Men With Localized Prostate Cancer

Eggener, Scott E.; Penson, David F.; Pavlovich, Christian P.; Chin, Joseph L.; Raman, Steven S.; Koch, Michaël; Fütterer, Jurgen J.; Relle, James; Hatiboglu, Gencay; Oto, Aytekin; Lotan, Yair; Heidenreich, Axel; Serrallach, Marc; Arora, Sandeep; Macura, Katarzyna J.; Tirkes, Temel; Costa, Daniel; Zagaja, Gregory P.; Persigehl, Thorsten; Sedelaar, J.P.M.; Staruch, Robert; Burtnyk, Mathieu; Bonekamp, David; Haider, Masoom A.; Klotz, Laurence

doi:10.1097/01.ju.0000557518.07195.d7

Cited by 2 publications

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“…Given the large prostate volume reduction in our present study, the median (IQR) biopsy sampling density at 12 months was 1.1 (0.8-1.4) cores/mL, similar to template mapping [13]. The 59% rate of any positive biopsy, due to intentional under-treatment, should diminish with more complete target treatments [14,15]. Moreover, in comparison with studies (that allow multiple retreatments) using similar ablation coverage and comprehensive post-ablation biopsy schedules, TULSA in the present study had comparable positive biopsy rates [10,16].…”

Section: Discussionsupporting

confidence: 59%

“…Overall maintenance of IIEF-15 scores and erection firmness sufficient for penetration was similar to focal HIFU and VTP [10,11] and possibly higher than wholegland HIFU [12]. While conservative target boundaries in the present study may have biased towards a more favourable AE and QoL profile, the rate of significant events in the ensuing 110-patient TACT study (ClinicalTrials.gov Identifier: ) with ablation to the capsule has been similar [14,15].…”

Section: Discussionmentioning

confidence: 53%

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Magnetic resonance imaging‐guided transurethral ultrasound ablation in patients with localised prostate cancer: 3‐year outcomes of a prospective Phase I study

et al. 2020

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S.M.N. and G.H. contributed equally towards the data analysis and article preparation. ObjectivesTo report the 3-year follow-up of a Phase I study of magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) in 30 men with localised prostate cancer. Favourable 12-month safety and ablation precision were previously described. Patients and MethodsAs a mandated safety criterion, TULSA was delivered as near whole-gland ablation, applying 3-mm margins sparing 10% of peripheral prostate tissue in 30 men. After 12-month biopsy and MRI, biannual follow-up included prostate-specific antigen (PSA), adverse events (AEs), and functional quality-of-life assessment, with repeat systematic biopsy at 3 years. ResultsA 3-year follow-up was completed by 22 patients. Between 1 and 3 years, there were no new serious or severe AEs. Urinary and bowel function remained stable. Erectile function recovered by 1 year and was stable at 3 years. The PSA level decreased 95% to a median (interquartile range) nadir of 0.33 (0.1-0.4) ng/mL, stable to 0.8 (0.4-1.6) ng/mL at 3 years. Serial biopsies identified clinically significant disease in 10/29 men (34%) and any cancer in 17/29 (59%). By 3 years, seven men had recurrence (four histological, three biochemical) and had undergone salvage therapy without complications (including six prostatectomies). At 3 years, three of 22 men refused biopsy, and two of the 22 (9%) had clinically significant disease (one new, one persistent). Predictors of salvage therapy requirement included less extensive ablation coverage and higher PSA nadir. ConclusionWith 3-year Phase I follow-up, TULSA demonstrates safe and precise ablation for men with localised prostate cancer, providing predictable PSA and biopsy outcomes, without affecting functional abilities or precluding salvage therapy.

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Section: Discussionsupporting

confidence: 59%

Section: Discussionmentioning

confidence: 53%

Magnetic resonance imaging‐guided transurethral ultrasound ablation in patients with localised prostate cancer: 3‐year outcomes of a prospective Phase I study

et al. 2020

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“…Importantly, the study design precluded evaluation of longer-term oncological outcomes. However, the long-term safety and efficacy of whole-gland TULSA are being assessed in larger cohorts [18,26]. Another limitation is that, due to the treat-and-resect study design, a conservative treatment strategy was ethically required near the NVB, contributing to residual cancer found on histology in four patients, all outside the intended targeted region within the 3 mm safety margins.…”

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confidence: 99%

Feasibility of MRI-guided transurethral ultrasound for lesion-targeted ablation of prostate cancer

Anttinen

Mäkelä

Suomi

et al. 2019

Scandinavian Journal of Urology

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Background: MRI-guided transurethral ultrasound ablation (TULSA) has been evaluated for organ-confined prostate cancer (PCa). The purpose of this study was to assess the safety and toxicity, accuracy and short-term evolution of cell-death after lesion-targeted TULSA. Methods: This prospective, registered, Phase-I treat-and-3-week-resect-study enrolled six patients with MRI-visible-biopsy-concordant PCa. Lesions were targeted using TULSA with radical intent, except near neurovascular bundles (NVB). Robot-assisted-laparoscopic-prostatectomy (RALP) was performed at 3 weeks. Post-TULSA assessments included MRI (1 and 3 weeks), adverse events and quality-of-life (QoL) to 3 weeks, followed by RALP and whole-mount-histology. Treatment accuracy and demarcation of thermal injury were assessed using MRI and histology. Results: Six patients (median age ¼ 70 years, prostate volume ¼ 60 ml, PSA ¼ 8.9 ng/ml) with eight biopsy-confirmed MRI-lesions (PIRADS 3) were TULSA-treated without complications (median sonication and MRI-times of 17 and 117 min). Foley-catheter removal was uneventful at 2-3 days. Compared to baseline, no differences in QoL were noted at 3 weeks. During follow-up, MRI-derived non-perfused-volume covered ablated targets and increased 36% by 3 weeks, correlating with necrosis-area on histology. Mean histological demarcation between complete necrosis and outer-limit-ofthermal-injury was 1.7 ± 0.4 mm. Coagulation necrosis extended to capsule except near NVB, where 3 mm safety-margins were applied. RALPs were uncomplicated and histopathology showed no viable cancer within the ablated tumor-containing target. Conclusions: Lesion-targeted TULSA demonstrates accurate and safe ablation of PCa. A significant increase of post-TULSA non-perfused-volume was observed during 3 weeks follow-up concordant with necrosis on histology. TULSA achieved coagulation necrosis of all targeted tissues. A limitation of this treat-and-resect-study-design was conservative treatment near NVB in patients scheduled for RALP.

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Lba-26 pivotal Trial of Mri-Guided Transurethral Ultrasound Ablation in Men With Localized Prostate Cancer

Abstract: Conclusions: 177Lu-PSMA-617 radionuclide therapy is well tolerated in patients with progressive mCRPC. PSA declined by >[50% in 38% of patients. The best PSA response rate occurred after 3 cycles. Updated data will be provided at the time of the conference.

Cited by 2 publications

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Magnetic resonance imaging‐guided transurethral ultrasound ablation in patients with localised prostate cancer: 3‐year outcomes of a prospective Phase I study

Magnetic resonance imaging‐guided transurethral ultrasound ablation in patients with localised prostate cancer: 3‐year outcomes of a prospective Phase I study

Feasibility of MRI-guided transurethral ultrasound for lesion-targeted ablation of prostate cancer

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