Relief of Lower Urinary Tract Symptoms After MRI-Guided Transurethral Ultrasound Ablation for Localized Prostate Cancer: Subgroup Analyses in Patients with Concurrent Cancer and Benign Prostatic Hyperplasia

Hatiboglu, Gencay; Relle, James; Zorn, Kevin C.; Bhojani, Naeem; Chin, Joseph L.

doi:10.1089/end.2020.0511

Cited by 12 publications

(13 citation statements)

References 20 publications

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“…A subgroup of men with primary or recurrent PCa concurrent with LUTS was also identified (2 cohorts, 33 patients). 10 , 17 Men were followed for relief of LUTS after TULSA treatment for PCa if baseline IPSS ≥12 in one study, and if patients reported LUTS and full work-up confirmed a benign prostatic hyperplasia diagnosis in the other ( Table 1 ). 10 , 17 In total, 224 men were treated with TULSA.…”

Section: Evidence Synthesis and Resultsmentioning

confidence: 99%

“…Two studies also evaluated relief of symptoms after TULSA in men with PCa concurrent with LUTS ( Table 3 ). 10 , 17 One study incorporated a targeted treatment plan, directed specifically to the transition zone and/or extension or obstruction in the bladder neck while also targeting PCa. 10 The other study assessed incidental symptom relief in a subgroup of men from the PCa Phase I study after subtotal ablation of the inner 90% of the prostate.…”

Section: Evidence Synthesis and Resultsmentioning

confidence: 99%

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Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Cancer: A Systematic Review

Dora

Clarke

Frey

et al. 2022

Journal of Endourology

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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.

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Section: Evidence Synthesis and Resultsmentioning

confidence: 99%

Section: Evidence Synthesis and Resultsmentioning

confidence: 99%

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Cancer: A Systematic Review

Dora

Clarke

Frey

et al. 2022

Journal of Endourology

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“…Moreover, of the five other patients with antegrade ejaculation at baseline, four retained it despite having their ejaculatory ducts directly ablated. Another potential benefit of TULSA is that it can be used as a combined therapy for localised PCa and symptomatic BPO, where the dominant index lesion and the obstructive adenomatous tissue could be ablated in the same treatment session [16]. More investigation is warranted for these applications.…”

Section: Discussionmentioning

confidence: 99%

“…More recently, TULSA has been investigated for salvage treatment of radiorecurrent PCa [14] and palliative treatment of locally advanced PCa [15]. Results from a retrospective subgroup analysis of nine men with localised PCa and concurrent symptomatic BPO who underwent TULSA showed encouraging results, reporting an 89% improvement in IPSS and quality of life (QoL), and preservation of antegrade ejaculations in eight out of nine patients at 12 months after TULSA [16], although the few patients and retrospective study design makes it difficult to draw any firm conclusions.…”

Section: Introductionmentioning

confidence: 99%

Magnetic resonance imaging‐guided transurethral ultrasound ablation for benign prostatic hyperplasia: 12‐month clinical outcomes of a phase I study

et al. 2021

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To investigate the safety and feasibility of magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) for the treatment of benign prostatic obstruction (BPO). Patients and methodsAn investigator-initiated, prospective, registered (NCT03350529), phase I study enrolled men with lower urinary tract symptoms due to benign prostatic hyperplasia in need of surgical intervention. Patients were followed for 12 months after TULSA. Uroflowmetry, prostate-specific antigen (PSA) level, and a comprehensive set of functional questionnaires including the Expanded Prostate cancer Index Composite-26, International Prostate Symptom Score (IPSS) and five-item version of the International Index of Erectile Function were obtained at baseline and every 3 months afterwards. MRI was obtained at baseline, and at 3 and 12 months after TULSA. Medication use before and after TULSA were recorded. Adverse events (AEs) were reported using the Clavien-Dindo classification. ResultsA total of 10 men underwent TULSA with no severe AEs encountered. The baseline median (interquartile range [IQR]) age and prostate volume were 68 (63-72) years and 53 (45-66) mL, respectively. At baseline, six patients were moderately symptomatic and four patients severely symptomatic. Nine patients at baseline were on BPO medication. The median (IQR) improvement in the IPSS was 82%, from 17.5 (15.3-23.0) at baseline to 4.0 (2.3-6.3) at 12 months. Similarly, the median maximum urinary flow rate improved by 101%, from a median (IQR) of 12.4 (8.8-17.6) mL/s at baseline to 21.8 (17.6-26.5) mL/s at 12 months. Improvements were already seen at 3 months. The median prostate volume and PSA reduction at 12 months were 33% and 48%, respectively. There were no changes in continence, sexual, erectile or bowel functions. At 12 months, five out of six men with normal ejaculatory function before TULSA reported normal antegrade ejaculations. All patients taking BPO medication before TULSA discontinued medication after TULSA. ConclusionTULSA appears to be a safe and effective treatment for BPO, with promising 12-month follow-up outcomes. Further studies with larger cohorts are needed to confirm the observed results.

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“…The incidental, ameliorating effect of TULSA treatment on lower urinary tract symptoms (LUTS) has recently been described for a subgroup of the overall population of Phase I patients who entered the study with cancer and concomitant LUTS ( 13 ). However, a comparison between the Phase I and TACT cohorts is described here for the first time.…”

Section: Discussionmentioning

confidence: 99%

Single-Center Evaluation of Treatment Success Using Two Different Protocols for MRI–Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer

et al. 2021

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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.

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Relief of Lower Urinary Tract Symptoms After MRI-Guided Transurethral Ultrasound Ablation for Localized Prostate Cancer: Subgroup Analyses in Patients with Concurrent Cancer and Benign Prostatic Hyperplasia

Cited by 12 publications

References 20 publications

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Cancer: A Systematic Review

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Cancer: A Systematic Review

Magnetic resonance imaging‐guided transurethral ultrasound ablation for benign prostatic hyperplasia: 12‐month clinical outcomes of a phase I study

Single-Center Evaluation of Treatment Success Using Two Different Protocols for MRI–Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer

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