A Description and Safety Overview of Irreversible Electroporation for Prostate Tissue Ablation in Intermediate-Risk Prostate Cancer Patients: Preliminary Results from the PRESERVE Trial.

The PRESERVE study (NCT04972097) aims to evaluate the safety and effectiveness of the NanoKnife System to ablate prostate tissue in patients with intermediate-risk prostate cancer (PCa). The NanoKnife uses irreversible electroporation (IRE) to deliver high-voltage electrical pulses to change the permeability of cell membranes, leading to cell death. A total of 121 subjects with organ-confined PCa ≤ T2c, prostate-specific antigens (PSAs) ≤ 15 ng/mL, and a Gleason score of 3 + 4 or 4 + 3 underwent focal ablation of the index lesion. The primary endpoints included negative in-field biopsy and adverse event incidence, type, and severity through 12 months. At the time of analysis, the trial had completed accrual with preliminary follow-up available. Demographics, disease characteristics, procedural details, PSA responses, and adverse events (AEs) are presented. The median (IQR) age at screening was 67.0 (61.0-72.0) years and Gleason distribution 3 + 4 (80.2%) and 4 + 3 (19.8%). At 6 months, all patients with available data (n = 74) experienced a median (IQR) percent reduction in PSA of 67.6% (52.3-82.2%). Only ten subjects (8.3%) experienced a Grade 3 adverse event; five were procedure-related. No Grade ≥ 4 AEs were reported. This study supports prior findings that IRE prostate ablation with the NanoKnife System can be performed safely. Final results are required to fully assess oncological, functional, and safety outcomes.

Comparative Effectiveness of Partial Gland Cryoablation Versus Robotic Radical Prostatectomy for Cancer Control.

BACKGROUND AND OBJECTIVE: There is an absence of high-level evidence comparing oncologic endpoints for partial gland ablation, and most series use prostate-specific antigen (PSA) rather than biopsy endpoints. Our aim was to compare oncologic outcomes between partial gland cryoablation (PGC) and radical prostatectomy (RP) for prostate cancer. METHODS: This was a retrospective, single-center analysis of subjects treated with PGC (n = 98) or RP (n = 536) between January 2017 and December 2022 as primary treatment for intermediate-risk (Gleason grade group [GG] 2-3) prostate cancer. Oncologic endpoints included surveillance biopsies per protocol after PGC in comparison to serial PSA testing after RP. The primary outcome was treatment failure, defined as a need for any salvage treatment or development of metastatic disease. Treatment failure and survival analyses were conducted using Cox proportional-hazard regression and Kaplan Meier survival curves. KEY FINDINGS AND LIMITATIONS: After applying the inclusion/exclusion criteria, the PGC (n = 75) and RP (n = 298) groups were compared. PGC patients were significantly older (71 vs 64 yr; p < 0.001), but there were no differences in PSA, biopsy GG, or treatment year between the groups. The PGC group had higher rates of treatment failures at 24 mo (33% vs 11%; p < 0.001) and 48 mo (43% vs 14%; p < 0.001). One PGC patient (2.1%) and one RP patient (0.7%) developed metastases by 48-mo follow-up (p = 0.4). On adjusted analysis, PGC was associated with a higher risk of treatment failure (hazard ratio 4.6, 95% confidence interval 2.7-7.9; p < 0.001). Limitations include observational biases associated with the retrospective study design. CONCLUSIONS: This is the first comparative effectiveness study of cancer control outcomes for PGC versus RP. The results demonstrate an almost fivefold higher risk of treatment failure with PGC during short-term follow-up. PATIENT SUMMARY: We compared cancer control outcomes for patients with intermediate-risk prostate cancer treated with partial gland cryoablation versus radical prostatectomy. We found that partial gland cryoablation had an almost fivefold higher risk of treatment failure. Men with prostate cancer should be counseled regarding this difference in treatment failure.

Prostate Cancer Detection Rate of Transperineal Prostate Biopsy: Cognitive vs Software Fusion, A Multicenter Analysis.

OBJECTIVE: To compare clinically significant prostate cancer detection with TP-TBx utilizing software vs cognitive fusion. It is established that MRI prior to prostate biopsy improves detection of clinically significant cancer (csPCa, Grade Group ≥2). MRI/US fusion targeted biopsy via a transperineal approach (TP-TBx) is increasing in utilization due to the clean percutaneous approach that greatly reduces postbiopsy infection. However, the comparative effectiveness of formal software fusion over cognitive fusion remains under studied. MATERIALS AND METHODS: We performed a retrospective multicenter study from June 2020 to July 2022 including age, race, prostate-specific antigen (PSA), prostate volume, PI-RADS, lesion size(s), number of cores sampled, indication (elevated PSA, prior negative, active surveillance) and anesthesia type. Surgeon preference determined use of cognitive (PrecisionPoint) vs software fusion techniques. Multivariable logistic regression determined factors associated with TP-TBx detection of csPCa. RESULTS: We identified 490 patients (201 cognitive, 289 software fusion) who underwent TP-TBx. Patient age, PSA, number of targets, and PI-RADS were similar (all P > .05). Software fusion TP-TBx had 4 [95% confidence interval (CI) 3-5] more (estimated median difference) systematic cores sampled. csPCa was detected in 44% of all patients. In adjusted analysis, cognitive vs software fusion was similar in detection of csPCa (odds ratio 1.46, 95% CI 0.82-2.58). CONCLUSION: Cognitive vs software fusion TP-TBx has similar csPCa detection, despite fewer systematic cores taken with cognitive fusion. The expense, additional time requirement, and similar outcomes of software fusion platforms confers higher value to cognitive TP-Bx.

Multi-institutional Retrospective Study of Percutaneous Cholangioscopy-Assisted Lithotripsy for Inoperable Calculous Cholecystitis.

PURPOSE: This study aimed to assess the safety and efficacy of percutaneous lithotripsy for gallstone eradication in patients with calculous cholecystitis with stones >1 cm. MATERIALS AND METHODS: Multi-institutional institutional review board approved retrospective review of patients who presented with calculous cholecystitis and were not determined to be surgical candidates. All patients underwent percutaneous cholecystostomy tube placement for acute infection, which was later exchanged for a large sheath for ShockPulse (Olympus, Tokyo, Japan) lithotripsy and stone destruction. Review parameters included procedural technical and clinical data, including clinical presentation, mean length of hospital stay, and postintervention symptom reduction. RESULTS: Twelve patients (mean age, 74.6 years; range, 52-94 years; 6 men and 6 women) underwent large-bore sheath (24-30 F) cholangioscopy-assisted gallstone destruction via rigid lithotripsy. The size of the gallstones ranged from 1.2 to 4.0 cm. All patients had prior cholecystostomy access for a mean of 25 weeks before gallstone extraction to ensure tract maturation via transhepatic or transperitoneal access. The technical success rate in single-session stone removal was 100%, with no major procedure-related adverse events. All patients were symptom- and pain-free after the procedure. The mean procedure time was 111.5 minutes, and the mean fluoroscopy time was 19.2 minutes. The median length of hospital stay was 1 day after the procedure. The mean time from percutaneous lithotripsy to biliary tube removal was 35 days (range, 17-45 days). CONCLUSIONS: Fluoroscopy-guided percutaneous rigid lithotripsy is a safe and effective procedure for gallstone destruction and extraction in patients who are poor surgical candidates with large lumen-occupying cholelithiasis.

MRI-guided focused ultrasound focal therapy for patients with intermediate-risk prostate cancer: a phase 2b, multicentre study.

BACKGROUND: Men with grade group 2 or 3 prostate cancer are often considered ineligible for active surveillance; some patients with grade group 2 prostate cancer who are managed with active surveillance will have early disease progression requiring radical therapy. This study aimed to investigate whether MRI-guided focused ultrasound focal therapy can safely reduce treatment burden for patients with localised grade group 2 or 3 intermediate-risk prostate cancer. METHODS: In this single-arm, multicentre, phase 2b study conducted at eight health-care centres in the USA, we recruited men aged 50 years and older with unilateral, MRI-visible, primary, intermediate-risk, previously untreated prostate adenocarcinoma (prostate-specific antigen ≤20 ng/mL, grade group 2 or 3; tumour classification ≤T2) confirmed on combined biopsy (combining MRI-targeted and systematic biopsies). MRI-guided focused ultrasound energy, sequentially titrated to temperatures sufficient for tissue ablation (about 60-70°C), was delivered to the index lesion and a planned margin of 5 mm or more of normal tissue, using real-time magnetic resonance thermometry for intraoperative monitoring. Co-primary outcomes were oncological outcomes (absence of grade group 2 and higher cancer in the treated area at 6-month and 24-month combined biopsy; when 24-month biopsy data were not available and grade group 2 or higher cancer had occurred in the treated area at 6 months, the 6-month biopsy results were included in the final analysis) and safety (adverse events up to 24 months) in all patients enrolled in the study. This study is registered with ClinicalTrials.gov, NCT01657942, and is no longer recruiting. FINDINGS: Between May 4, 2017, and Dec 21, 2018, we assessed 194 patients for eligibility and treated 101 patients with MRI-guided focused ultrasound. Median age was 63 years (IQR 58-67) and median concentration of prostate-specific antigen was 5·7 ng/mL (IQR 4·2-7·5). Most cancers were grade group 2 (79 [78%] of 101). At 24 months, 78 (88% [95% CI 79-94]) of 89 men had no evidence of grade group 2 or higher prostate cancer in the treated area. No grade 4 or grade 5 treatment-related adverse events were reported, and only one grade 3 adverse event (urinary tract infection) was reported. There were no treatment-related deaths. INTERPRETATION: 24-month biopsy outcomes show that MRI-guided focused ultrasound focal therapy is safe and effectively treats grade group 2 or 3 prostate cancer. These results support focal therapy for select patients and its use in comparative trials to determine if a tissue-preserving approach is effective in delaying or eliminating the need for radical whole-gland treatment in the long term. FUNDING: Insightec and the National Cancer Institute.

Comparative Effectiveness and Tolerability of Transperineal MRI-Targeted Prostate Biopsy under Local versus Sedation.

OBJECTIVES: To assess the prostate cancer diagnostic yield, complications, and costs of transperineal prostate biopsies when performed with local anesthesia versus sedation. METHODS: Data were prospectively collected for men undergoing transperineal MRI-targeted biopsy at the outpatient clinic and tertiary hospital of a single center between October 2017 to February 2020. These data included demographic, procedural, and pathologic variables and complications. Time-driven activity-based costing was performed to compare procedural costs. RESULTS: 126 men were included. Age, BMI and PSA were similar for local (n = 45) vs sedation (n = 81), all P>0.05. Detection of clinically significant prostate cancer (CSPC) on combined systematic and targeted biopsy was similar for local vs sedation (24% vs 36%; P = 0.2). Local had lower detection on targeted biopsies alone (8.9% vs 25%; P = 0.03). However, fewer targeted cores were obtained per region of interest with local vs sedation (median 3 vs 4 cores; P<0.01). For local vs sedation, the complication rate was 2.6% and 6.1% (P = 0.6). The median visual analog pain score for local vs sedation was 3/10 vs 0/10 (P<0.01). The mean procedure time for local vs sedation was 22.5 vs 17.5 minutes (48.3 minutes when including anesthesia time). Time-driven activity-based costs for local vs sedation were $961.64 vs $2208.16 (P<0.01). CONCLUSION: Transperineal biopsy with local anesthesia is safe with comparable outcomes to sedation. While the number of cores taken differed, there was no statistical difference in the detection of clinically significant cancer.

Varicocele Embolization: Patient Selection: Preprocedure Workup, and Technical Considerations.

Varicocele refers to an abnormally dilated and tortuous pampiniform venous plexus within the spermatic cord. The prevalence of varicocele is reported to be approximately 15% in the general male population. Its incidence increases with age and has a higher incidence in infertile men. Varicocele treatment (surgical or interventional) is considered one of the most common therapies of reversible infertility in men. Percutaneous embolization offers nonsurgical, minimally invasive option for the treatment of varicoceles, requiring only minimal sedation. In this article, the authors review the clinical and technical details of percutaneous varicocele embolization with a summary of currently available evidence.

Microwave ablation of cT1a renal cell carcinoma: oncologic and functional outcomes at a single center.

PURPOSE: Percutaneous ablation is an established alternative to surgical intervention for small renal masses. Radiofrequency and cryoablation have been studied extensively in the literature. To date, series assessing the efficacy and safety of microwave ablation (MWA) are limited. We present a cohort of 110 renal tumors treated with MWA. METHODS: A review of the medical record between January 2015 and July 2019 was performed, retrospectively identifying 101 patients (110 tumors). All ablations were performed by a single board-certified urologist/interventional radiologist. Demographic information, intraoperative, postoperative, and follow-up surveillance data were recorded. RESULTS: Median (IQR) age was 69.7 years (60.8-77.0); 27 (24%) were female. Median (IQR) BMI was 27.0 (25.1-30.2) and Charleston Comorbidity Index was 5.0 (4.0-6.0). 82 tumors were biopsy-confirmed renal cell carcinoma/oncocytic neoplasms. Median (IQR) tumor size was 2.0 cm (1.5-2.6). Median (IQR) RENAL nephrometry score was 6.0 (5.0-8.0). Technical success was achieved in all patients and all but one patient were discharged on the same day. Median (IQR) eGFR at baseline and 1 year were 71.9 mL/min/1.73 m2 (56.5-82) and 63.0 mL/min/1.73 m2 (54.0-78.2); the difference was -5.3 (p = 0.12). Two Clavien-Dindo type-I complications, one type-II complication, and one type-III complication were experienced in this cohort. Median radiographic follow-up was 376.5 days with 2 tumors (2.4% of RCC/oncocytic neoplasms) having recurred to date. CONCLUSIONS: MWA is a safe and efficacious treatment option for small renal masses with minimal adverse events and low rates of recurrence in this cohort of 101 patients. Continued follow-up is needed to assess long-term outcomes.

A Deep Learning Approach to Diagnostic Classification of Prostate Cancer Using Pathology-Radiology Fusion.

BACKGROUND: A definitive diagnosis of prostate cancer requires a biopsy to obtain tissue for pathologic analysis, but this is an invasive procedure and is associated with complications. PURPOSE: To develop an artificial intelligence (AI)-based model (named AI-biopsy) for the early diagnosis of prostate cancer using magnetic resonance (MR) images labeled with histopathology information. STUDY TYPE: Retrospective. POPULATION: Magnetic resonance imaging (MRI) data sets from 400 patients with suspected prostate cancer and with histological data (228 acquired in-house and 172 from external publicly available databases). FIELD STRENGTH/SEQUENCE: 1.5 to 3.0 Tesla, T2-weighted image pulse sequences. ASSESSMENT: MR images reviewed and selected by two radiologists (with 6 and 17 years of experience). The patient images were labeled with prostate biopsy including Gleason Score (6 to 10) or Grade Group (1 to 5) and reviewed by one pathologist (with 15 years of experience). Deep learning models were developed to distinguish 1) benign from cancerous tumor and 2) high-risk tumor from low-risk tumor. STATISTICAL TESTS: To evaluate our models, we calculated negative predictive value, positive predictive value, specificity, sensitivity, and accuracy. We also calculated areas under the receiver operating characteristic (ROC) curves (AUCs) and Cohen's kappa. RESULTS: Our computational method (https://github.com/ih-lab/AI-biopsy) achieved AUCs of 0.89 (95% confidence interval [CI]: [0.86-0.92]) and 0.78 (95% CI: [0.74-0.82]) to classify cancer vs. benign and high- vs. low-risk of prostate disease, respectively. DATA CONCLUSION: AI-biopsy provided a data-driven and reproducible way to assess cancer risk from MR images and a personalized strategy to potentially reduce the number of unnecessary biopsies. AI-biopsy highlighted the regions of MR images that contained the predictive features the algorithm used for diagnosis using the class activation map method. It is a fully automatic method with a drag-and-drop web interface (https://ai-biopsy.eipm-research.org) that allows radiologists to review AI-assessed MR images in real time. LEVEL OF EVIDENCE: 1 TECHNICAL EFFICACY STAGE: 2.

Real-world comparative effectiveness of shockwave lithotripsy versus ureterorenoscopy for the treatment of urinary stones.

PURPOSE: To identify clinical and non-clinical predictors of treatment failure and perioperative complications following ureterorenoscopy versus shockwave lithotripsy. METHODS: The New York State Department of Health Statewide Planning and Research Cooperative System (SPARCS) database was used to identify 226,331 patients who underwent index ureteroscopy or shockwave lithotripsy for renal stones from 2000 to 2016. Propensity-matched generalized linear-mixed modeling was utilized to compare failure and complication rates between the two procedure groups. RESULTS: 219,383 individuals meeting inclusion criteria who underwent either ureterorenoscopy (n = 124,342) or shockwave lithotripsy (n = 95,041) in New York State between 2000 and 2016 were included in our analysis. After propensity score matching, patients undergoing shockwave lithotripsy were found to have decreased odds of experiencing any type of 30-day complication (P < 0.001 for all) but increased odds of treatment failure at both 90 (OR 1.70, 95% CI 1.64-1.77) and 180 (OR 1.83, 95% CI 1.76-1.89) days (P < 0.001 for both). CONCLUSION: Patients undergoing shockwave lithotripsy experienced significantly higher odds of treatment failure, although this undesirable outcome appears to be partially offset by lower 30-day complication rates.

Contemporary Results and Clinical Utility of Renal Mass Biopsies in the Setting of Ablative Therapy: A single center experience.

PURPOSE: Clinical guidelines have recently included renal mass biopsy (RMB) in management algorithms, especially in the setting of small renal masses ≤ 4 cm (SRM) and ablative therapy. We sought to evaluate the diagnostic rates of RMB, factors associated with a non-diagnostic biopsy, its clinical utility, and its safety profile in the setting of ablative therapy. MATERIALS AND METHODS: A total of 174 RMB from 167 patients, performed in a tertiary academic center from 01/2015 to 01/2019, were included. Patient demographics, radiographic mass size, RMB diagnoses, subsequent clinical management, and complications were retrospectively reviewed. RMBs were classified as diagnostic or non-diagnostic based on set criteria. RESULTS: The mean mass size was 3.0 cm (range: 0.5-15.3 cm) and 140 biopsies (80%) were SRM. Among all RMB, 159 (91%) were diagnostic and 15 (9%) were non-diagnostic. Non-diagnostic biopsies were associated with small mass size, the presence of a cystic component (p < 0.00001) and fewer number of cores submitted (p = 0.0046). All non-diagnostic biopsies occurred in SRMs, where the mean mass size was significantly smaller than diagnostic biopsies (1.3 versus 3.2 cm, p = 0.001). RMB with concurrent ablation yielded non-diagnostic results more frequently than isolated RMBs (15% vs 2%, respectively). CONCLUSIONS: RMB is useful for definitive diagnosis and clinical management in the setting of ablative therapy. Small mass size, cystic lesions, and fewer number of passes obtained are associated with non-diagnostic biopsies. When a renal mass diagnosis is particularly critical, a separate biopsy procedure prior to ablative therapy is recommended.

Is There a Role for Combination, Single-Session Selective Transarterial Embolization and Microwave Ablation for Large Renal Masses?

PURPOSE: Thermal ablation of small renal tumors is safe and efficacious. Thermoablation of tumors greater than 3 cm has decreased efficacy and a greater risk of complications. Combined embolization and radiofrequency ablation has shown encouraging results. We report on the use of combined single-session transarterial embolization and microwave ablation to treat large renal masses. MATERIALS AND METHODS: After obtaining IRB approval, a review of the medical record between October 2016 and January 2020 was performed. Patients with renal tumors who underwent combined transarterial embolization and microwave ablation were assessed retrospectively. Patient demographic information, intraoperative, postoperative, and follow-up data were recorded. RESULTS: Eleven patients were identified meeting inclusion criteria. The mean age was 73 years, with 64% male, an average BMI of 26.5, and average Charleston Comorbidity Index of 6.7. Nine tumors were identified as clear cell carcinoma, one as papillary carcinoma and one as an oncocytic neoplasm. Average tumor size was 4.5 cm (2.7-8.3), with an average RENAL score of 8.5. Successful ablation with a 5 mm margin was achieved in all patients, and in all cases, ablation and embolization were performed on the same day. The only related post-procedure complication was a single groin hematoma. Surveillance was performed with CT or MRI. Average follow-up was 419.5 days (range 27-747), with no patients showing evidence of recurrence to date. CONCLUSIONS: Combined single-session transarterial embolization and microwave ablation is technically feasible, safe, and efficacious in treating large renal tumors in a series of 11 patients with no recurrence to date. LEVEL OF EVIDENCE: Level 4, case series.

Management of the Small Renal Mass: a 2020 Update.

PURPOSE OF REVIEW: Small renal masses (≤ cT1a, less than 4 cm) are a subset of renal tumors with low malignant and metastatic potential but increasing incidence given increased use of cross-sectional imaging. Here, we review the diagnostic and treatment options available for the lesions. RECENT FINDINGS: While the low metastatic potential of SRMs has been known, recent studies show that 30% of SRMs removed surgically are benign. Renal biopsy is a tool that can be implemented to help with diagnosis before treatment (options of which include active surveillance, ablation, and surgery). Active surveillance might be associated with worse cancer-specific survival but all interventional methods appear to fare similarly. Advancements have also been made in percutaneous ablation techniques, and they now are included on multiple guideline statements. Active surveillance, surgery (PN and RN), and thermal ablation are all treatment options for SRMs with similar outcomes but varying side effects.