Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Cancer.

PURPOSE: Magnetic resonance imaging-guided transurethral ultrasound ablation uses directional thermal ultrasound under magnetic resonance imaging thermometry feedback control for prostatic ablation. We report 12-month outcomes from a prospective multicenter trial (TACT). MATERIALS AND METHODS: A total of 115 men with favorable to intermediate risk prostate cancer across 13 centers were treated with whole gland ablation sparing the urethra and apical sphincter. The co-primary 12-month endpoints were safety and efficacy. RESULTS: In all, 72 (63%) had grade group 2 and 77 (67%) had NCCN® intermediate risk disease. Median treatment delivery time was 51 minutes with 98% (IQR 95-99) thermal coverage of target volume and spatial ablation precision of ±1.4 mm on magnetic resonance imaging thermometry. Grade 3 adverse events occurred in 9 (8%) men. The primary endpoint (U.S. Food and Drug Administration mandated) of prostate specific antigen reduction ≥75% was achieved in 110 of 115 (96%) with median prostate specific antigen reduction of 95% and nadir of 0.34 ng/ml. Median prostate volume decreased from 37 to 3 cc. Among 68 men with pretreatment grade group 2 disease, 52 (79%) were free of grade group 2 disease on 12-month biopsy. Of 111 men with 12-month biopsy data, 72 (65%) had no evidence of cancer. Erections (International Index of Erectile Function question 2 score 2 or greater) were maintained/regained in 69 of 92 (75%). Multivariate predictors of persistent grade group 2 at 12 months included intraprostatic calcifications at screening, suboptimal magnetic resonance imaging thermal coverage of target volume and a PI-RADS™ 3 or greater lesion at 12-month magnetic resonance imaging (p <0.05). CONCLUSIONS: The TACT study of magnetic resonance imaging-guided transurethral ultrasound whole gland ablation in men with localized prostate cancer demonstrated effective tissue ablation and prostate specific antigen reduction with low rates of toxicity and residual disease.

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

OBJECTIVES: To 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 METHODS: As 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. RESULTS: A 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. CONCLUSION: With 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.

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.

Background: MRI-guided transurethral ultrasound ablation (TULSA) offers minimally invasive thermal ablation of benign and malignant prostate tissue, using directional high-intensity ultrasound and real-time, magnetic resonance thermometry feedback control. Feasibility of TULSA for alleviating lower urinary tract symptoms (LUTSs) associated with benign prostatic hyperplasia (BPH) is retrospectively assessed in a subgroup of men from a localized prostate cancer study who also had LUTSs. Patients and Methods: TULSA was used to ablate 90% of the prostate gland in 30 men with localized prostate cancer, without plans to spare ejaculatory ducts. Mean ± standard deviation treatment time was 37 ± 10 minutes. Retrospective analysis was conducted on a subpopulation of nine patients who also suffered from LUTSs (International Prostate Symptom Score [IPSS] ≥ 12 at baseline) as well as a smaller subgroup of five patients with IPSS >12 and peak urinary flow (Qmax) <15 mL/second. Urinary symptom relief, continence, and erectile function were assessed using IPSS, International Index of Erectile Function (IIEF), and uroflowmetry. Results: At 12 months post-TULSA, IPSS improved significantly by 58% to 6.3 ± 5.0 (p = 0.003), with at least a moderate (≥6 points) reduction in eight of nine patients. IPSS quality of life improved in eight of nine patients. Erectile function (IIEF-EF) remained stable from 14.6 ± 9.3 at baseline to 15.7 ± 9.0 at 12 months. The proportion of patients with erections sufficient for penetration (IIEF Q2 ≥2) was unchanged. Full urinary continence (pad free and leak free) was achieved at 12 months in all patients. In five men who suffered from more severe symptoms, Qmax increased from 11.6 ± 2.6 mL/second to 22.5 ± 14.2 mL/second at 12 months (p = 0.126). Perfused prostate volume, measured on MRI, decreased 70% to 13.6 ± 4.6 mL (p = 0.003) at 12 months. All adverse events were mild to moderate (Common Terminology Criteria for Adverse Events [CTCAE] Grade 1-2) with no serious events reported. Conclusions: This retrospective analysis demonstrates promising safety and feasibility of TULSA to relieve LUTSs, with improvement in IPSS comparable with modern, minimally invasive surgical therapies. Larger controlled studies with BPH-specific ablation plans in men seeking treatment for LUTSs are warranted.

Ureteral Stent Fracture After Irreversible Electroporation for Treatment of Metastatic Rectal Adenocarcinoma.

Background: Irreversible electroporation (IRE) is a soft tissue ablation technique using electrical pulses without thermal energy to create pores in the cell membrane, resulting in death from apoptosis rather than necrosis. Advantages include protection of blood vessels, nerves, and surrounding structures. Documented complications include periprocedure nausea/vomiting, infection, and severe pain. Ureteral stents are frequently used in management of hydronephrosis caused by malignant obstruction. We describe what is to our knowledge the first documentation of stent fragmentation secondary to IRE and subsequent management. Case Presentation: This is a 61-year-old male with history of metastatic rectal adenocarcinoma treated initially with chemotherapy and surgery. Follow-up imaging revealed hydronephrosis and enlarged right iliac lymph node. Ureteral stent was placed for management of the hydronephrosis and the patient was referred to undergo IRE for management of metastatic disease. After treatment, the patient had imaging performed that showed fractured right ureteral stent with proximal portion in the ureter and distal portion floating freely in the bladder. This complication was managed with staged endoscopic procedure involving adjacent ureteral stent placement and subsequent ureteroscopy and stent removal using delta grasper. Conclusion: We describe to our knowledge the first incidence as well as subsequent management of ureteral stent fracture from an increasingly common treatment modality for metastatic disease. Given the frequency of malignant ureteral obstruction managed with ureteral stents, knowledge of potential complications pertaining to the urologist is imperative.

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

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 36min (IQR: 26-44) and prostate volume was 44ml (IQR: 38-48). Spatial control of thermal ablation was ±1.3mm on 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 (1mm) and has a well-tolerated side effect profile. A larger study is under way. TRIAL REGISTRATION: NCT01686958, DRKS00005311.

Insight into current surgical techniques and practice patterns associated with robotic-assisted radical prostatectomy: a national survey of urologists within the USA.

Robotic-assisted radical prostatectomy (RARP) has been rapidly adopted throughout the USA. The purpose of this study is to describe the prevailing RARP operative techniques and perceptions within the USA. An anonymous web-based survey was sent electronically to a list of 920 robotic urological surgeons. The survey assessed surgeon demographics, surgical technique, and postoperative care related to RARP. The study was comprised of urologists from community hospitals (76%) and university hospitals/specialty centers (24%). All geographic sections of the American Urological Association were represented. The most common neurovascular preservation techniques were ante/retrograde approach (48%), athermal (22%), and preservation of lateral pelvic fascia (17%). Surgeon choice of neurovascular preservation technique varied with the average number of procedures performed per year (P = 0.0065). High-volume surgeons tended to require a higher number of robotic cases in order to go through the learning curve of the "comfortable" (P = 0.001) and "expert" levels (P < 0.0001). The majority of surgeons reported that RARP (as compared with open surgery) improved urinary continence (77.2%), sexual function (65.6%), and surgical margin rates (53.8%). RARP is an evolving surgical procedure with significant variability in practice patterns among US surgeons. Further studies are necessary to compare the various techniques in order to improve surgical outcomes.