Initial experience of transurethral ultrasound ablation of the prostate in Asia.
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ABSTRACT:
SUBMITTER: Miura M
PROVIDER: S-EPMC9579879 | biostudies-literature | 2022 Nov
REPOSITORIES: biostudies-literature
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Initial experience of transurethral ultrasound ablation of the prostate in Asia.
Miura Masayoshi M Takahashi Satoru S Fukumoto Maiko M Higashiyama Hiroshi H
BJUI compass 20220623 6
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Project description:Background and objectiveToxicity from local salvage therapy for radiorecurrent prostate cancer (PCa) remains a concern. This phase 2 study evaluates the outcomes of salvage magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (sTULSA).MethodsMen with biochemically relapsed, biopsy-proven PCa following definitive radiotherapy underwent whole- or partial-gland sTULSA (NCT03350529). Prostate-confined recurrence was confirmed by MRI and prostate-specific membrane antigen (PSMA) positron emission tomography (PET) computed tomography (CT). The primary endpoints were safety (Clavien-Dindo classification) and efficacy (prostate-specific antigen [PSA], PSMA PET-CT, and MRI-targeted biopsy at 12 mo). The secondary endpoints included functional and survival outcomes.Key findings and limitationsThirty-nine patients underwent sTULSA (64% whole gland), with a median age of 73 yr (interquartile range [IQR]: 69-77) and PSA of 3.3 ng/ml (IQR: 2-6.2). Three patients had undergone prior salvage therapy, 16 were receiving hormonal therapy at enrollment, and 12 had a history of transurethral interventions. Eighteen patients had incidental urethral strictures on baseline cystoscopy. Over a median follow-up of 40 mo (IQR: 24-55), 56% experienced adverse events. Severe genitourinary toxicity (Clavien-Dindo ≥3 or hospitalization) occurred in 28%, including three patients with puboprostatic fistulas and two patients requiring cystectomy. Leak-free continence was maintained in 53%. At 12 mo, 89% showed no cancer in the targeted area, with a median PSA reduction of 95% (p < 0.001). Five-year metastasis-free, failure-free, and biochemical recurrence-free survival probabilities (95% confidence interval) were 97% (0.93-1.00), 70% (0.54-0.91), and 54% (0.31-0.93), respectively. Limitations included single-arm design and moderate sample size.Conclusions and clinical implicationsIt has been observed that sTULSA is effective for radiorecurrent PCa, although genitourinary toxicity remains a concern. Further studies should refine patient selection and treatment parameters to improve safety and tolerability.Patient summaryIn this study, we examined a new treatment called magnetic resonance imaging-guided transurethral ultrasound ablation for prostate cancer that has returned after radiation therapy. We found that the treatment provided effective and lasting cancer control for most patients. However, a notable number of patients experienced significant genitourinary toxicity, including severe adverse effects affecting urinary function. Careful patient selection is crucial to minimize these adverse effects and ensure the best results.
| S-EPMC11656090 | biostudies-literature
Project description:Purpose: MRI-guided transurethral ultrasound ablation (TULSA) uses real-time MR thermometry feedback to target prostate disease. We systematically review the literature to synthesize efficacy, functional, and safety outcomes and assess the influence of planned ablation fraction on outcome. Materials and Methods: PubMed, Embase, and the Cochrane Library were searched from inception to June 2021 following Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Studies reporting at least one efficacy, functional, or safety outcome after a single TULSA treatment were included. The relationship of freedom from salvage treatment and potency preservation with planned ablation volume was modeled. Results: Two hundred twenty-four patients were treated in 10 studies with up to a 5-year follow-up, mainly for primary localized prostate cancer (PCa) plus smaller cohorts with recurrent PCa, and locally advanced PCa (LAPC). The prostate-specific antigen decline from baseline up to 2 years, including focal to whole-gland ablation plans, was 54% to 97%. The rate of salvage treatment after one TULSA treatment for primary PCa was 7% to 17%. Continence and potency preservation were from 92% to 100% and from 75% to 98%. Urinary symptoms were stable in men with good voiding function at baseline, and 85% of men with concurrent PCa and lower urinary tract symptoms met the criteria for improvement. Symptom relief in a small cohort of men with LAPC was observed. Grade III adverse events were incurred by 13/224 men (6%), with no rectal injury/fistula or Grade IV complication. The planned ablation fraction was linearly related to salvage-free survival. The relationship between potency preservation and planned ablation fraction followed a sigmoid curve. Conclusions: As an alternative to conventional treatments, TULSA is safe and effective for prostate tissue ablation in men with primary PCa. There is also evidence that TULSA delivers effective relief of urinary symptoms while treating PCa in a single, low-morbidity procedure. The likelihood of freedom from additional treatment or potency preservation is associated with the planned ablation fraction.
| S-EPMC9231661 | biostudies-literature
Project description:OBJECTIVE:To report on the use of RFA for the treatment of symptomatic benign and autonomously functioning thyroid nodules (AFTNs) in the first reported UK cohort. METHODS:Patients treated over a 19-month period were retrospectively reviewed. Nodules were assessed pre-treatment and at 1 and 6?months post-treatment. Nodule volume was calculated and cosmetic assessment and thyroid-related quality of life (QoL) scores were recorded at each time point. Thyroid function tests (TFTs) were recorded at all three time points for patients with ATFNs. RESULTS:46 patients with 50 nodules were treated with no complications. The mean volume reduction 1-month post-treatment was 53 +- 14.9 % ( p < 0.0001). Six month data was available for 31 nodules and showed a mean 67 +- 17.6%?vol reduction ( p < 0.0001). Five of the six patients with ATFNs were euthyroid at 1-month post-procedure. 6-month data was available on three of these patients, and all remained euthyroid. The thyroid-related QoL and cosmetic scores also improved. Data from 23 patients was available pre-treatment and at 6?months post-treatment and there was a significant ( p < 0.0001) reduction in QoL score. Pre-treatment, 82 % of nodules were readily visible at rest, decreasing to 12.5 % 6 months after treatment ( p < 0.0001). CONCLUSIONS:Results align with published data suggesting that RFA is effective at reducing nodule volume and at treating ATFNs and leads to improvement in thyroid-related QoL and cosmetic scores. ADVANCES IN KNOWLEDGE:This early UK experience demonstrates that day-case radiofrequency ablation can provide safe and effective treatment of benign symptomatic thyroid nodules.
| S-EPMC6592080 | biostudies-literature
Project description:BackgroundUp to half of all men who undergo primary radiotherapy for localized prostate cancer (PCa) experience local recurrence.ObjectiveTo evaluate the safety and early functional and oncological outcomes of salvage magnetic resonance imaging-guided transurethral ultrasound ablation (sTULSA) for men with localized radiorecurrent PCa.Design setting and participantsThis prospective, single-center phase 1 study (NCT03350529) enrolled men with biopsy-proven localized PCa recurrence after radiotherapy. Multiparametric magnetic resonance imaging (mpMRI) and 18F prostate-specific membrane antigen-1007 (18F PSMA-1007) positron emission tomography (PET)-computed tomography (CT) were used to confirm organ-confined disease localization. Patients underwent either whole-gland or partial sTULSA, depending on their individual tumor characteristics.Outcome measurements and statistical analysisPatients were followed at 3-mo intervals. Adverse events (AEs, Clavien-Dindo scale), functional status questionnaires (Expanded Prostate Cancer Index [EPIC]-26, International Prostate Symptom Score, International Index of Erectile Function-5), uroflowmetry, and prostate-specific antigen (PSA) were assessed at every visit. Disease control was assessed at 1 yr using mpMRI and 18F-PSMA-1007 PET-CT, followed by prostate biopsies.Results and limitationsEleven patients (median age 69 yr, interquartile range [IQR] 68-74) underwent sTULSA (3 whole-gland, 8 partial sTULSA) and have completed 12-mo follow-up. Median PSA was 7.6 ng/ml (IQR 4.9-10) and the median time from initial PCa diagnosis to sTULSA was 11 yr (IQR 9.5-13). One grade 3 and three grade 2 AEs were reported, related to urinary retention and infection. Patients reported a modest degradation in functional status, most significantly a 20% decline in the EPIC-26 irritative/obstructive domain at 12 mo. A decline in maximum flow rate (24%) was also observed. At 1 yr, 10/11 patients were free of any PCa in the targeted ablation zone, with two out-of-field recurrences. Limitations include the nonrandomized design, limited sample size, and short-term oncological outcomes.ConclusionssTULSA appears to be safe and feasible for ablation of radiorecurrent PCa, offering encouraging preliminary oncological control.Patient summaryWe present safety and 1-yr functional and oncological outcomes of magnetic resonance imaging-guided transurethral ultrasound ablation (TULSA) as a salvage treatment for local prostate cancer recurrence after primary radiation. Salvage TULSA is safe and shows the ability to effectively ablate prostate cancer recurrence, with acceptable toxicity.
| S-EPMC8317885 | biostudies-literature
Project description:The treatment of low-risk prostate cancer is a common clinical dilemma between standard curative whole gland therapy (and its associated quality of life diminishing side effects) and active surveillance (and its low, but real, risk of progression). The goal of focal therapy in low-risk prostate cancer is to achieve the best balance between cancer control and maintenance of quality of life. Magnetic resonance-guided focused ultrasound (MRgFUS) surgery is a non-invasive thermal ablation method that integrates magnetic resonance imaging for target identification, treatment planning and closed-loop control of thermal deposition and focused ultrasound for thermal ablation of the tumour target. This novel transrectal system allows for tumour localization, targeting and monitoring of tumour target ablation in real time, while simultaneously preserving adjacent normal tissue thereby minimizing the side effects of standard curative surgical or radiation therapy. We report the first North American clinical experience of treatment of localized prostate cancer with focal MR-guided transrectal focused ultrasound (clinicaltrial.gov identifier NCT01226576).
| S-EPMC3529739 | biostudies-literature
Project description:Focal therapy of prostate cancer is an evolving treatment strategy that destroys a predefined region of the prostate gland that harbors clinically significant disease. Although long-term oncologic control has yet to be demonstrated, focal therapy is associated with a marked decrease in treatment-related morbidity. Focal laser ablation is an emerging modality that has several advantages, most notably real-time magnetic resonance imaging (MRI) compatibility. This review presents the principles of laser ablation, the role of multiparametric MRI for delineating the site of significant prostate cancer, a summary of published clinical studies, and our initial experience with 23 patients, criteria for selecting candidates for focal prostate ablation, and speculation regarding future directions.
| S-EPMC4080850 | biostudies-literature
Project description:ObjectivesTo assess differences in 24-month oncologic and functional outcomes in men with low to intermediate-risk prostate cancer treated with MRI-guided transurethral ultrasound ablation (TULSA) using intentionally conservative versus intensified treatment parameters.Patients and methodsPatients from a single center involved in two multicenter trials were included in this analysis. This included 14 of 30 patients with Gleason 3 + 3 from a Phase I study using intentionally conservative treatment parameters, and 15 of 115 patients with Gleason ≤ 3 + 4 from a pivotal study using intensified parameters. Follow-up data compared across these cohorts included 12-month biopsy and MRI for all patients, and 24-month PSA, micturition and quality of life (IIEF, IPSS, IPSS-QOL). The prognostic value of baseline parameters and PSA kinetics on 12-month histological recurrence was evaluated by logistic regression.Results12-month biopsy revealed clinically significant residual disease in 4 (29%) and 2 (14%) patients from the Phase I and pivotal studies, respectively. PSA nadir was 0.7 ng/ml for Phase I and 0.5 ng/ml for pivotal study patients. Patient age at diagnosis, use of MRI fusion/systematic prostate biopsy, number of obtained cores at initial biopsy, PSA course, and PSA nadir were identified as prognostic factors for treatment success. All but one patient from each cohort maintained erection firmness sufficient for penetration. No cases of pad use were reported at 24 months. There were no Grade 4 or higher adverse events, and no late toxicity related to the procedure.ConclusionTwo-year follow-up demonstrated the efficacy of TULSA for the treatment of localized prostate cancer, and the durability of PSA and functional outcomes. Intensifying treatment parameters in the pivotal trial had no impact on safety or functional outcomes through 24 months, while reducing the recurrence rate for clinically significant disease. Careful patient selection by MRI fusion/systematic prostate biopsy and adequate follow-up through routine 12-month biopsy are recommended.
| S-EPMC8579125 | biostudies-literature
Project description:BackgroundMagnetic resonance-guided transurethral ultrasound ablation (MR-TULSA) is a new focal therapy for treating localised prostate cancer that is associated with fewer adverse effects (AEs) compared with established treatments. To support large-scale clinical implementation, information about cost-effectiveness is required.ObjectiveTo evaluate the cost-utility of MR-TULSA compared with robot-assisted radical prostatectomy (RARP), external beam radiation therapy (EBRT) and active surveillance (AS) for patients with low- to favourable intermediate-risk localised prostate cancer.Design, setting and participantsA Markov model was developed targeting 60-year-old men diagnosed with low- to intermediate-risk localised prostate cancer over a time horizon of 40 years from the German Statutory Health Insurance (SHI) perspective. To assess the robustness of the results, deterministic and probabilistic sensitivity analyses were performed.InterventionFour different treatment strategies were compared: minimally invasive MR-TULSA, two definitive approaches (RARP and EBRT) and one observational strategy (AS).Outcome measurements and statistical analysisOutcomes were measured in overall costs, quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio (ICER).ResultsAS generated the highest number of QALYs (12.67), followed by MR-TULSA (12.35), EBRT (12.35) and RARP (12.20). RARP generated the lowest costs (€ 46 997) over one patient's lifetime, while MR-TULSA was a slightly more expensive alternative (€48 826). The incremental cost-effectiveness ratio (ICER) of AS compared with RARP was €11 600 per QALY and of MR-TULSA compared with RARP was €12 193 per QALY, while EBRT was dominated. At a willingness-to-pay of €20 000 per QALY, the probability of being cost-effective is 44% for AS, 25% for RARP, 25% for MR-TULSA and 6% for EBRT.ConclusionsAll treatment options for 60-year-old men diagnosed with low- to intermediate-risk localised prostate cancer are affected by considerable uncertainty. Accepting high follow-up costs by applying a higher willingness-to-pay, AS is the most favourable treatment option.
| S-EPMC11752021 | biostudies-literature
Project description:Background We aimed to conduct a systematic review and meta-analysis of studies reporting functional and oncologic outcomes of combining whole-gland high-intensity focused ultrasound ablation (HIFU) with transurethral resection of the prostate (TURP) in prostate cancer (PCa) patients. Methods PubMed, Embase, Web of Science, Scopus, and Cochrane Library were systematically searched until June 30, 2022. The ROBINS-I tool scale was used to evaluate quality of eligible studies. Biochemical failure was defined according to the criteria used in each raw study. The presence of any cancer on follow-up biopsy was classified as “positive biopsy”. Patients able to penetrate their partner without pharmacologic support were rated potent. Meta-analysis was performed to evaluate functional outcomes using R project. Results A total of 1861 patients in 15 eligible studies were included. All studies were identified as moderate or high quality. There were 1388 (74.6%) patients with low-risk or intermediate-risk PCa in 15 studies and 473 (25.4%) patients with high-risk PCa in 12 studies. The mean PSA nadir postoperatively ranged from 0.20 to 1.90 ng/mL within average time of 1.9-12 months. Biochemical failure rates in all 15 studies ranged from 6.3% to 34% within average time of 1.9-60 months. Eleven studies reported the rates of positive biopsy ranged from 3% to 29.7% within average time of 3-12 months postoperatively. Based on the results of single-arm meta-analysis, the pooled rates of any degree urinary incontinence, acute urinary retention, urinary tract infections, and urethral stricture were 9.4% (95% CI: 6.1%-12.6%), 0.9% (95% CI: 0%-2%), 2.6% (95% CI: 0.8%-4.3%), and 4.3% (95% CI: 1.4%-7.1%), respectively. The pooled rate of being potent after procedure in previously potent patients was 43.6% (95% CI: 27.3%-59.8%). The sensitivity analysis revealed all the pooled results was relatively reliable. Egger’s tests for the pooled results of acute urinary retention (p = 0.0651) and potency (p = 0.6749) both did not show significant publication bias. Conclusions It appears that the combination treatment of whole-gland HIFU and TURP could be applied for PCa patients. It might have potential advantages of decreasing catheterization time and improving urinary status. Prospective and comparative studies are needed to validate our findings.
| S-EPMC9597449 | biostudies-literature
Project description:BackgroundCatheter ablation of ventricular tachycardia (VT) can be technically challenging due to difficulty with catheter positioning in the left ventricle (LV) and achieving stable contact. The Hansen Sensei Robotic system (HRS) has been used in atrial fibrillation but its utility in VT is unclear.ObjectiveThe purpose of this study was to test the technical feasibility of robotic catheter ablation of LV ventricular tachycardia (VT) using the HRS.MethodsTwenty-three patients underwent LV VT mapping and ablation with the HRS via a transseptal, transmitral valve approach. Nineteen patients underwent substrate mapping and ablation (18 had ischemic cardiomyopathy, 1 had an apical variant of hypertrophic cardiomyopathy). Four patients had focal VT requiring LV VT mapping and ablation. Procedural endpoints included substrate modification by endocardial scar border ablation and elimination of late potentials, or elimination of inducible focal VT.ResultsMapping and ablation were entirely robotic without requiring manual catheter manipulation in all patients and reaching all LV regions with stable contact. Fluoroscopy time of the LV procedure was 22.2 ± 11.2 minutes. Radiofrequency time was 33 ± 21 minutes. Total procedural times were 231 ± 76 minutes. Complications included a left groin hematoma (opposite to the HRS sheath), 1 pericardial effusion without tamponade that was drained successfully, and transient right ventricular failure in a patient with previous left ventricular assist device. At 13.4 ± 6.7 months of follow-up (range 1-19 months), recurrence of VT occurred in 3 of 23 patients.ConclusionOur initial experience suggests that the HRS allows successful mapping and ablation of LV VT.
| S-EPMC3298677 | biostudies-literature