Focal Irreversible Electroporation Research Articles

166 Radiation Therapy and IRreversible Electroporation (RTIRE) for Intermediate Risk Prostate Cancer

OBJECTIVES/GOALS: Prostate cancer treatment is associated with significant genitourinary side effects. There is a critical need for treatment with decreased morbidity. We report the development of a novel treatment paradigm combining irreversible electroporation and lower dose radiation to provide prostate cancer patients with a less morbid treatment. METHODS/STUDY POPULATION: Intermediate risk prostate cancer patients will undergo focal irreversible electroporation followed by low dose, whole gland radiation therapy. The primary endpoint is freedom from clinically significant cancer on biopsy at 12-month follow up. Secondary endpoints include safety profile, oncologic efficacy, effectiveness of RT and need for secondary treatment. This trial (NCT05345444) and currently actively recruiting patients after initial feasibility trial. Sample size is calculated to detect an increase in the proportion of patients who are cancer free at 1-year, from 0.80 to 0.95. An exact binomial test with a 10% one-sided significance level will have 94.3% power to detect the difference between the null and alternative hypothesis when the sample size is 42. RESULTS/ANTICIPATED RESULTS: This is a clinical trial in progress. DISCUSSION/SIGNIFICANCE: Combined irreversible electroporation (IRE) and a lower dose radiotherapy (RTIRE) may provide prostate cancer patients a treatment with minimal side effects.

Initial Experiences of Treating Prostate Cancer with Focal Irreversible Electroporation

Initial Experiences of Treating Prostate Cancer with Focal Irreversible Electroporation

Irreversible electroporation as a focal therapy for localized prostate cancer: A systematic review.

Irreversible electroporation (IRE) is a new and promising focal therapy for the treatment of localized prostate cancer. In this systematic review, we summarize the literature on IRE for prostate cancer published over the last decade. PubMed and EMBASE were searched with the end date of May 2023 to find relevant publications on prostate cancer ablation using IRE. Original studies with focal IRE as the primary curative treatment which reported on functional or oncological outcomes were included. The bibliography of relevant studies was also scanned to identify suitable articles. A total of 14 studies reporting on 899 patients treated with IRE for localized prostate cancer were included. Of all the studies reviewed, 77% reported on recurrence within the zone of ablation, and it ranged from 0% to 38.9% for in-field and 3.6% to 28% for out-of-field recurrence. Although, a standardised follow-up protocol was not followed, all the studies employed serial prostate-specific antigen monitoring, a multiparametric magnetic resonance imaging, and a biopsy (6-12 months post-treatment). Across all the studies, 58% reported that the urinary continence returned to the pretreatment levels and 25% reported a minor decrease in the continence from the baseline at 12-months of follow-up. Erections sufficient for intercourse varied from 44% to 75% at the baseline to 55% to 100% at 12-months of follow-up across all the studies. IRE, as a focal therapy, shows promising results with minimal complications and reasonably effective oncological control, but the data comparing it to the standard of care is still lacking. Future research should focus on randomized definitive comparisons between IRE, radical prostatectomy, and radiation therapy.

Radiation Therapy and Irreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE)

The objective of the RTIRE clinical trial (NCT05345444) is to demonstrate the feasibility, safety, and early oncologic efficacy of combining MRI-guided stereotactic body radiation therapy (MRgSBRT) with irreversible electroporation (IRE) for men with intermediate-risk localized prostate cancer. Inclusion criteria: 1) Men aged ≥18, 2) ECOG 0 -1, 3) Histologically confirmed intermediate risk prostate cancer per NCCN guidelines, 4) Focal grade group 2 (GG2) or 3 (GG3) cancer in multi-parametric magnetic resonance imaging (mpMRI) target, 5) Gland size < 80cc, 6) Ability to undergo IRE, 7) Ability to receive MRI-guided SBRT, 8) Ability to complete the HRQOL assessment surveys, 9) Willingness to undergo 12 month follow up biopsy. 1) Prior TURP, 2) Prior history of focal therapy, 3) Prior history of receiving pelvic radiotherapy, 4) Patient with history of inflammatory bowel disease, 5) History of bladder neck or urethral stricture. Study Design/Endpoints: This is a feasibility and safety study assessing the ability to perform IRE followed by real-time MRgSBRT. Subjects will undergo focal IRE followed by MRgSBRT (≥6 weeks after IRE) to the prostate +/- seminal vesicles prescribed to 32.5 Gy in 5 fractions. The primary endpoint of the first portion of the trial is feasibility, defined as at least 80% of subjects (8 of 10 subjects) undergoing assessment at 12-weeks post-IRE and at 6-weeks post-MRgSBRT within 1 year from enrollment of the first subject. The expansion phase will include an additional 40 subjects to assess side effect profile and early oncologic efficacy (n = 50) at 12 months post RTIRE. RTIRE has enrolled 8 subjects in 3 months and will proceed to the expansion phase. Secondary endpoints include: 1) short-term safety as measured by treatment-related adverse events, 2) oncologic efficacy as measured by number of subjects with presence of ≥GG2 cancer at 12 months post-RTIRE therapy, 3) health-related quality of life (HRQOL) as measured by Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP), International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF-5) 4) post-RTIRE prostate-specific antigen (PSA) kinetics including time to PSA nadir and post-nadir PSA stability, 5) assessment of pre and post-RTIRE mpMRI changes to evaluate the area of necrosis and presence of residual tissue, 6) rates of biochemical and clinical progression and the need for secondary or adjuvant treatment following RTIRE. Enrollment: 11 Subjects RESULTS: To be determined. To be determined.

V10-08 THE USE OF FOCAL IRREVERSIBLE ELECTROPORATION FOR PROSTATE CANCER

You have accessJournal of UrologyCME1 Apr 2023V10-08 THE USE OF FOCAL IRREVERSIBLE ELECTROPORATION FOR PROSTATE CANCER John Torosyan, Amy Cherry, Hasan Abbas, Shima Tayebi, and Abhinav Sidana John TorosyanJohn Torosyan More articles by this author , Amy CherryAmy Cherry More articles by this author , Hasan AbbasHasan Abbas More articles by this author , Shima TayebiShima Tayebi More articles by this author , and Abhinav SidanaAbhinav Sidana More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003328.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Focal therapy of prostate cancer is a treatment strategy that aims to destroy the cancer-containing parts of the prostate while preserving uninvolved prostatic tissue in an attempt to preserve genitourinary function. Irreversible Electroporation (IRE) is a novel ablative modality which utilizes electrical pulses to induce cell apoptosis and can be applied to various malignancies, including prostate cancer. The objective of this video is to discuss the mechanism of action of IRE and describe the components, setup, and operative technique for performing IRE for the focal treatment of prostate cancer. METHODS: IRE is performed under general anesthesia with the patient placed in lithotomy position. Monopolar electrodes are inserted into the prostate under ultrasound guidance and using a brachytherapy grid. The probes are placed 1.5 to 2cm away from one another, and 3-5mm away from the prostatic capsule using cognitive fusion to cover the lesion and 5-10mm margin. After initially estimating voltage configurations, ten test impulses are fired between each probe pair to assess resulting currents. Using test results, final voltages are assigned, and the remaining 80 impulses are fired between each probe pair. RESULTS: This case involves a 74-year-old male with a history of hypertension and hyperlipidemia who presented with an elevated Prostate-Specific Antigen (PSA) of 6.35 and was found to have Gleason 3+4 cancer in the Prostate Imaging Reporting & Data System (PI-RADS) 4 lesion localized in the right mid gland to apex. The patient had a pre-treatment International Prostate Symptom Score (IPSS) of 4-1 and a Sexual Health Inventory for Men (SHIM) of 18 without the use of erectile dysfunction medication. The patient underwent a successful IRE ablation of the lesion along with the margin. The procedure was tolerated well, and the patient was discharged later that day. At his 6-week follow-up, PSA declined to 0.66 and he had an unchanged IPSS/SHIM. CONCLUSIONS: The use of focal therapy in prostate cancer is promising because of its effectiveness paired with minimal procedural side effects. Focal IRE provides a safe and effective way to achieve focal therapy of prostate cancer. Source of Funding: None. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e928 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information John Torosyan More articles by this author Amy Cherry More articles by this author Hasan Abbas More articles by this author Shima Tayebi More articles by this author Abhinav Sidana More articles by this author Expand All Advertisement PDF downloadLoading ...

A Multicenter, Randomized, Single-blind, 2-Arm Intervention Study Evaluating the Adverse Events and Quality of Life After Irreversible Electroporation for the Ablation of Localized Low-intermediate Risk Prostate Cancer. Reply.

No AccessJournal of UrologyReply to Letters to the Editor16 Mar 2023A Multicenter, Randomized, Single-blind, 2-Arm Intervention Study Evaluating the Adverse Events and Quality of Life After Irreversible Electroporation for the Ablation of Localized Low-intermediate Risk Prostate Cancer. Reply. Kai Zhang, Jeremy Teoh, Pilar Laguna, Chi-Fai Ng, and Jean de la Rosette Kai ZhangKai Zhang Department of Urology, Beijing United Family Hospital and Clinics, Beijing, China More articles by this author , Jeremy TeohJeremy Teoh S.H. Ho Urology Centre, Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China More articles by this author , Pilar LagunaPilar Laguna Department of Urology, Istanbul Medipol Mega University Hospital, Istanbul, Turkey More articles by this author , Chi-Fai NgChi-Fai Ng S.H. Ho Urology Centre, Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China More articles by this author , and Jean de la RosetteJean de la Rosette Department of Urology, Istanbul Medipol Mega University Hospital, Istanbul, Turkey More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003405AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack Citations ShareFacebookLinked InTwitterEmail "A Multicenter, Randomized, Single-blind, 2-Arm Intervention Study Evaluating the Adverse Events and Quality of Life After Irreversible Electroporation for the Ablation of Localized Low-intermediate Risk Prostate Cancer. Reply.." The Journal of Urology, Publish Ahead of Print, pp. – REFERENCES 1. . A multicenter, randomized, single-blind, 2-arm intervention study evaluating the adverse events and quality of life after irreversible electroporation for the ablation of localized low-intermediate risk prostate cancer. J Urol.2023; 209(2):347-353. Link, Google Scholar 2. . Focal therapy in prostate cancer-report from a consensus panel. J Endourol. 2010; 24(5):775-780. Crossref, Medline, Google Scholar 3. . Magnetic resonance imaging-targeted biopsy may enhance the diagnostic accuracy of significant prostate cancer detection compared to standard transrectal ultrasound-guided biopsy: a systematic review and meta-analysis. Eur Urol.2015; 68(3):438-450. Crossref, Medline, Google Scholar 4. . Multiparametric MRI for prostate cancer diagnosis: current status and future directions. Nat Rev Urol.2020; 17(1):41-61. Crossref, Medline, Google Scholar 5. . Transperineal multiparametric magnetic resonance imaging-ultrasound fusion targeted prostate biopsy combined with standard template improves prostate cancer detection. J Urol.2022; 207(1):86-94. Link, Google Scholar 6. . Schema and cancer detection rates for transperineal prostate biopsy templates: a review. Ther Adv Urol.2022; 14:175628722211050. Crossref, Google Scholar 7. . EAU—EANM—ESTRO—ESUR—ISUP—SIOG guidelines on prostate cancer—2020 update. Part 1: screening, diagnosis, and local treatment with curative intent. Eur Urol.2021; 79(2):243-262. Crossref, Medline, Google Scholar 8. . Effect of focal vs extended irreversible electroporation for the ablation of localized low- or intermediate-risk prostate cancer on early oncological control: a randomized clinical trial. JAMA Surg.2023. doi: 10.1001/jamasurg.2022.7516. Crossref, Google Scholar 9. . An updated systematic review on focal therapy in localized prostate cancer: what has changed over the past 5 years?Eur Urol.2022; 81(1):5-33. Crossref, Medline, Google Scholar 10. . Pair-matched patient-reported quality of life and early oncological control following focal irreversible electroporation versus robot-assisted radical prostatectomy. World J Urol.2018; 36(9):1383-1389. Crossref, Medline, Google Scholar Submitted February 26, 2023; accepted March 2, 2023; published 000. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kai Zhang Department of Urology, Beijing United Family Hospital and Clinics, Beijing, China More articles by this author Jeremy Teoh S.H. Ho Urology Centre, Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China More articles by this author Pilar Laguna Department of Urology, Istanbul Medipol Mega University Hospital, Istanbul, Turkey More articles by this author Chi-Fai Ng S.H. Ho Urology Centre, Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China More articles by this author Jean de la Rosette Department of Urology, Istanbul Medipol Mega University Hospital, Istanbul, Turkey More articles by this author Expand All Submitted February 26, 2023; accepted March 2, 2023; published 000. Advertisement PDF downloadLoading ...

Radiation therapy and irreversible electroporation for intermediate risk prostate cancer (RTIRE).

TPS403 Background: The objective of the RTIRE clinical trial (NCT05345444) is to demonstrate the feasibility, safety, and early oncologic efficacy of combining MRI-guided stereotactic body radiation therapy (MRgSBRT) with irreversible electroporation (IRE) for men with intermediate-risk localized prostate cancer. Methods: Inclusion criteria: 1) Men aged ≥18, 2) ECOG 0 –1, 3) Histologically confirmed intermediate risk prostate cancer per NCCN guidelines, 4) Focal grade group 2 (GG2) or 3 (GG3) cancer in multi-parametric magnetic resonance imaging (mpMRI) target, 5) Gland size &lt; 80cc, 6) Ability to undergo IRE, 7) Ability to receive MRI-guided SBRT, 8) Ability to complete the HRQOL assessment surveys, 9) Willingness to undergo 12 month follow up biopsy. Exclusion criteria: 1) Prior TURP, 2) Prior history of focal therapy, 3) Prior history of receiving pelvic radiotherapy, 4) Patient with history of inflammatory bowel disease, 5) History of bladder neck or urethral stricture. Study Design/Endpoints: This is a feasibility and safety study assessing the ability to perform IRE followed by real-time MRgSBRT. Subjects will undergo focal IRE followed by MRgSBRT (&gt;6 weeks after IRE) to the prostate +/- seminal vesicles prescribed to 32.5 Gy in 5 fractions. The primary endpoint of the first portion of the trial is feasibility, defined as at least 80% of subjects (8 of 10 subjects) undergoing assessment at 12-weeks post-IRE and at 6-weeks post-MRgSBRT within 1 year from enrollment of the first subject. The expansion phase will include an additional 40 subjects to assess side effect profile and early oncologic efficacy (n=50) at 12 months post RTIRE. RTIRE has enrolled 8 subjects in 3 months and will proceed to the expansion phase. Secondary endpoints include: 1) short-term safety as measured by treatment-related adverse events, 2) oncologic efficacy as measured by number of subjects with presence of ≥GG2 cancer at 12 months post-RTIRE therapy, 3) health-related quality of life (HRQOL) as measured by Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP), International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF-5) 4) post-RTIRE prostate-specific antigen (PSA) kinetics including time to PSA nadir and post-nadir PSA stability, 5) assessment of pre and post-RTIRE mpMRI changes to evaluate the area of necrosis and presence of residual tissue, 6) rates of biochemical and clinical progression and the need for secondary or adjuvant treatment following RTIRE. Clinical trial information: NCT05345444 .

Effect of Focal vs Extended Irreversible Electroporation for the Ablation of Localized Low- or Intermediate-Risk Prostate Cancer on Early Oncological Control

Focal ablative irreversible electroporation (IRE) is a therapy that treats only the area of the tumor with the aim of achieving oncological control while reducing treatment-related functional detriment. To evaluate the effect of focal vs extended IRE on early oncological control for patients with localized low- and intermediate-risk prostate cancer. In this randomized clinical trial conducted at 5 centers in Europe, men with localized low- to intermediate-risk prostate cancer were randomized to receive either focal or extended IRE ablation. Data were collected at baseline and at regular intervals after the procedure from June 2015 to January 2020, and data were analyzed from September 2021 to July 2022. Oncological outcome as indicated by presence of clinically significant prostate cancer (International Society of Urological Pathology grade ≥2) on transperineal template-mapping prostate biopsy at 6 months after IRE. Descriptive measures of results from that biopsy included the number and location of positive cores. A total of 51 and 55 patients underwent focal and extended IRE, respectively. Median (IQR) age was 64 years (58-67) in the focal ablation group and 64 years (57-68) in the extended ablation group. Median (IQR) follow-up time was 30 months (24-48). Clinically significant prostate cancer was detected in 9 patients (18.8%) in the focal ablation group and 7 patients (13.2%) in the extended ablation group. There was no significant difference in presence of clinically significant prostate cancer between the 2 groups. In the focal ablation group, 17 patients (35.4%) had positive cores outside of the treated area, 3 patients (6.3%) had positive cores in the treated area, and 5 patients (10.4%) had positive cores both in and outside of the treated area. In the extended group, 10 patients (18.9%) had positive cores outside of the treated area, 9 patients (17.0%) had positive cores in the treated area, and 2 patients (3.8%) had positive cores both in and outside of the treated area. Clinically significant cancer was found in the treated area in 5 of 48 patients (10.4%) in the focal ablation group and 5 of 53 patients (9.4%) in the extended ablation group. This study found that focal and extended IRE ablation achieved similar oncological outcomes in men with localized low- or intermediate-risk prostate cancer. Because some patients with intermediate-risk prostate cancer are still candidates for active surveillance, focal therapy may be a promising option for those patients with a high risk of cancer progression. ClinicalTrials.gov Identifier: NCT01835977.

Median 4-year outcomes of salvage irreversible electroporation for localized radio-recurrent prostate cancer.

To evaluate the safety, and short to mid-term oncological and quality-of-life (QoL) outcomes of focal irreversible electroporation (IRE) for radio-recurrent prostate cancer (PCa) at a median follow-up of 4 years. This was a single-centre series of men with biopsy-proven radio-recurrent PCa treated with IRE between December 2013 and February 2022, with a minimum follow-up of 6 months. Follow-up included magnetic resonance imaging at 6 months, and standard transperineal saturation template biopsies at 12 months. Further biopsies were guided by suspicion on serial imaging or prostate-specific antigen (PSA) levels. Validated questionnaires were used to measure functional outcomes. Significant local recurrence was defined as any International Society of Urological Pathology (ISUP) score ≥ 2 on biopsies. Progression-free survival was defined as no signs of local or systemic disease on either imaging or template biopsies, or according to the Phoenix criteria for biochemical recurrence. Final analysis was performed on 74 men with radio-recurrent PCa (median age 69 years, median PSA level 5.4 ng/mL, 76% ISUP score 2/3). The median (range) follow-up was 48 (27-68) months. One rectal fistula occurred, and eight patients developed urethral sloughing that resolved with transurethral resection. Among patients who returned questionnaires (30/74, 41%), 93% (28/30) had preserved urinary continence and 23% (7/30) had sustained erectile function at 12-month follow-up. Local control was achieved in 57 patients (77%), who needed no further treatment. Biopsy diagnosed 41(55%) patients received follow up template biopsies, in-field recurrences occurred in 7% (3/41), and out-field recurrences occurred in 15% of patients (6/41). The metastasis-free survival rate was 91% (67/74), with a median (interquartile range) time to metastases of 8 (5-27) months. The Kaplan-Meier estimated 5-year progression-free survival rate was 60%. These short- to mid-term safety, oncological and QoL outcome data endorse results from smaller series and show the ability of salvage focal IRE to safely achieve oncological control in patients with radio-recurrent PCa.

Focal Irreversible Electroporation for Localized Prostate Cancer - Oncological and Safety Outcomes Using mpMRI and Transperineal Biopsy Follow-Up.

Irreversible electroporation (IRE) technology for prostate cancer (PC) generates consecutive electrical pulses between pairs of electrodes which move through tumorous cells, irreversibly perforate their membranes and eventually lead to cell death, while avoiding tissue thermal effect. The technique is used for primary focal lesions as well as for focal salvage cases. This series reports short term oncological control, quality of life and safety results. Retrospective data were collected from 45 consecutive cases of primary (N=38) and salvage (N=7) PC patients treated with IRE. All patients had transperineal MRI/US fusion biopsy and PET-PSMA scan prior to treatment, to verify single lesion. Transperineal Nano-Knife IRE system was used in day-care theatre. Patients had 6 months mpMRI, blood PSA and 1 year confirmatory biopsy following procedure. Quality of life was recorded during the first year. Median primary subgroup analysis (N=38): age 69 years, initial PSA 5.6 ng/dL, lesion size 0.8 mL and ISUP Group 2 (1-3). Median salvage subgroup analysis (N=7): age 76 years, initial PSA 11.9 ng/dL, lesion size 2.0 mL and ISUP Group 4 (1-5). Median catheter time 5 (3-7) days. No Clavien-Dindo>1 complications were reported nor re-admissions, incontinence, strictures or fistulas. 5% of patients were given PDE-5i drugs. Primary group PSA dropped by 39%, mpMRI clearance in 84%, out-field new lesion in 12%, in-field lesion in 4%. Biopsy at 1 year: 4 patients had out-field clinically significant PC, thus 3 had re-IRE and 1 had radiation therapy. Salvage subgroup MRI clearance was 60%, and 52% remained on active surveillance by 1 year. IRE treatment for focal PC is safe for primary and salvage cases, if done by a meticulously skilled and trained team, and under strict protocols. The short term oncological results are promising especially for primary lesions. Long term oncological results will be published over time.

Median 5-year outcomes of primary focal irreversible electroporation for localised prostate cancer.

To evaluate longer-term oncological and functional outcomes of focal irreversible electroporation (IRE) as primary treatment for localised clinically significant prostate cancer (csPCa) at a median follow-up of 5 years (up to 10 years). All patients that underwent focal IRE as primary treatment for localised PCa between February 2013 and August 2021 with a minimum 12 months of follow-up were analysed. Follow-up included 6-month magnetic resonance imaging (MRI) and standardised transperineal saturation template±targeted biopsies at 12 months, and further biopsies in the case of clinical suspicion on serial imaging and/or prostate-specific antigen (PSA) levels. Failure-free survival (FFS) was defined as no progression to radical treatment or nodal/distant disease. Local recurrence was defined as any International Society of Urological Pathology Grade of ≥2 on biopsy. A total of 229 patients were analysed with a median (interquartile range [IQR]) follow-up of 60(40-80)months. The median (IQR) age was 68(64-74)years, the median (IQR) PSA level was 5.9(4.1-8.2)ng/mL, and 86% harboured intermediate-risk disease and 7% high-risk disease. In all, 38 patients progressed to radical treatment (17%), at a median (IQR) of 35(17-53)months after IRE. Kaplan-Meier FFS rates were 91% at 3 years, 84% at 5 years and 69% at 8 years. Metastasis-free survival was 99.6% (228/229), PCa-specific and overall survival were 100% (229/229). Residual csPCa was found in 24% (45/190) during follow-up biopsy and MRI showed a complete ablation in 82% (186/226). Short-term urinary continence was preserved (98%, three of 144 at baseline, 99%, one of 131 at 12 months) and erections sufficient for intercourse decreased by 13% compared to baseline (71% to 58%). Longer-term follow-up confirms our earlier findings that focal IRE provides acceptable local and distant oncological control in selected men with less urinary and sexual toxicity than radical treatment. Long-term follow-up and external validation of these findings, is required to establish this new treatment paradigm as a valid treatment option.

The SAFE Pilot Trial-SAlvage Focal Irreversible Electroporation-For Recurrent Localized Prostate Cancer: Rationale and Study Protocol.

IntroductionCurrently, the majority of prostate cancer (PCa) recurrences after non-surgical first-line treatment are managed with androgen-deprivation therapy (ADT). Salvage radical prostatectomy (sRP) is a curative alternative to ADT but yields significant morbidity. Preliminary evidence from focal salvage treatments shows similar oncological control but lower morbidity compared to sRP. Among available ablative focal energies, irreversible electroporation (IRE) is a treatment modality that proved promising, especially in treating apical lesions, where PCa most often recurs. Our aim is to test the safety of salvage IRE for recurrent PCa.MethodsWe performed a single-arm pilot feasibility study (IDEAL stage 2a): SAFE, SAlvage Focal irreversible Electroporation for recurrent localized PCa. Twenty patients with biopsy-proven PCa recurrence after primary non-surgical (radiation or ablation) treatment were included. All men will undergo mpMRI ± targeted biopsies, pre-operative PSMA-PET staging before inclusion and sIRE. Outcomes will be evaluated through internationally validated questionnaires and morbidity scales. All men will undergo a control biopsy at one year.ResultsPrimary objectives were the evaluation of the safety of sIRE (and patients’ quality of life) after treatment. Secondary objectives were the evaluation of functional outcomes, namely, continence and erectile function changes and evaluation of short-term oncological efficacy.ConclusionsSAFE is the second pilot study to evaluate sIRE and the first one performed according to the most recent diagnostic and staging imaging standards. sIRE may provide a curative option for recurrent PCa together with lower comorbidities compared to sRP.

Diagnostic Accuracy of Multiparametric Magnetic Resonance Imaging to Detect Residual Prostate Cancer Following Irreversible Electroporation—A Multicenter Validation Study

BackgroundAccurate monitoring following focal treatment of prostate cancer (PCa) is paramount for timely salvage treatment or retreatment. ObjectiveTo evaluate the diagnostic accuracy of multiparametric magnetic resonance imaging (mpMRI) to detect residual PCa in the short-term follow-up of focal treatment with irreversible electroporation (IRE) using transperineal or transrectal template ± targeted biopsies. Design, setting, and participantsA retrospective international multicenter study of men with biopsy-proven PCa, treated with focal IRE, and followed by mpMRI (index-test) and template biopsies (reference-test) between February 2013 and January 2021, was conducted. Outcome measurements and statistical analysisSensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of mpMRI were calculated for in- and outfield residual disease based on two definitions of significant PCa: University College London (UCL) 1—International Society of Urological Pathology (ISUP) ≥3 or ISUP ≥1 with maximum cancer core length (MCCL) ≥6 mm, and UCL2—ISUP ≥2 or ISUP ≥1 with MCCL ≥4 mm. Results and limitationsA total of 303 patients from five focal therapy centers were treated with primary IRE. The final analysis was performed on 217 men (median age 67, median prostate-specific antigen 6.2, 81% ISUP 2/3) who underwent both mpMRI and template biopsies. Multiparametric MRI missed 38/57 (67%) positive biopsy locations (UCL1) in 22 patients. Sensitivity, specificity, PPV, and NPV of mpMRI to detect whole gland residual disease (UCL1) were 43.6% (95% confidence interval [CI]: 28–59), 80.9% (95% CI: 75–86), 33.3% (95% CI: 21–47), and 86.7% (95% CI: 81–91), respectively. Based on UCL2, sensitivity, specificity, PPV, and NPV were 35.8% (95% CI: 25–48), 82.0% (95% CI: 75–88), 47.1% (95% CI: 34–61), and 74.1% (95% CI: 67–80), respectively. Limitations are the retrospective nature and short follow-up. ConclusionsThe diagnostic accuracy of mpMRI to detect residual clinically significant PCa following IRE was low. Follow-up template biopsies should be performed, regardless of mpMRI results. Patient summaryWe investigated the accuracy of magnetic resonance imaging (MRI) to detect residual prostate cancer after treatment with irreversible electroporation. The accuracy of MRI is insufficient, and we emphasize the importance of confirmatory prostate biopsies.

Salvage robot-assisted radical prostatectomy following focal ablation with irreversible electroporation: feasibility, oncological and functional outcomes

BackgroundTo report the feasibility, oncological and functional outcomes of salvage robot-assisted radical prostatectomy (sRARP) for recurrent prostate cancer (PCa) after irreversible electroporation (IRE).MethodsThis was a retrospective analysis of patients who underwent sRARP by a single high-volume surgeon after IRE treatment in our institution. Surgical complications, oncological and functional outcomes were assessed.Results15 patients with at least 12 months follow up were identified out of the 234 men who underwent primary IRE between 2013 and 2019. The median [IQR] age was 68 (62–70) years. The median [IQR] time from focal IRE to sRARP was 42 (21–57) months. There were no rectal, bladder or ureteric injuries. The T-stage was pT2 in 9 (60%) patients and pT3a in 6 (40%) patients. Only one (7%) patient had a positive surgical margin. At a median [IQR] follow up of 22 (16–32) months no patient had a biochemical recurrence (PSA > 0.2). All 15 patients were continent (pad-free) by 6 months and 9 (60%) patients had erections sufficient for intercourse with or without PDE5 inhibitors. No predisposing factors were identified for predicting erectile dysfunction after sRARP.ConclusionsIn patients with recurrent or residual significant PCa after focal IRE ablation it is feasible to obtain good functional and oncological outcomes with sRARP. Our results demonstrate that good outcomes can be achieved with sRARP, when respecting close monitoring post-IRE, good patient selection and surgical experience. The limitations of this study are that it is a small series, with short follow up and a lack of standardised quality of life instruments.

Incidence and patterns of recurrence of prostate cancer on surveillance prostate biopsy following focal therapy with nanoknife

Purpose: Our aim was to evaluate histological in-field clearance of prostate cancer at >12 months post focal irreversible electroporation (IRE) and assess the incidence and patterns of recurrence on surveillance prostate biopsy.

Focal therapy for prostate cancer with irreversible electroporation: Oncological and functional results of a single institution study.

PurposeFocal irreversible electroporation (IRE) for prostate cancer aims to reduce quality of life complications, however outcomes data remains limited. We aimed to evaluate histological in-field clearance of prostate cancer at ≥12 months post-IRE.Materials and MethodsRetrospective review of prospectively acquired data of consecutive patients treated between August 2018 and August 2021. Significant recurrence was defined as a ≥6 mm core Gleason 3+3, or ≥Gleason 3+4 with ≥4 mm tumour length. A second definition of any focus of International Society of Urological Pathology (ISUP) ≥2 was also analysed.ResultsThe median follow-up of the entire cohort is 23 months (range 3–39 mo). For 64 primary IRE procedures, surveillance biopsy was performed in 40/50 (80.0%) with ≥12 months follow-up. Significant in-field recurrence occurred in 3/40 (7.5%), or 4/40 (10.0%) with any focus of ISUP >2. Significant out-of-field recurrence occurred in 5/40 (12.5%). In salvage IRE, three patients (3/6, 50.0%) have undetectable prostate-specific antigen levels, two have no residual cancer on biopsy and one patient had out-of-field recurrence. For sexually active men, erectile function was maintained in 24/28 (85.7%) of primary IRE. No incontinence developed in primary IRE (0/64).ConclusionsFocal primary IRE for prostate cancer is associated with 90% infield ablation of any ISUP grade >2 cancer with a low risk of urinary incontinence or impotence. Surveillance prostate biopsies are required to exclude progression despite a normal post-IRE multiparametric magnetic resonance imaging (mpMRI). Salvage IRE is a promising option for localised recurrence after prostate radiotherapy with low morbidity.

Detailing sexual outcomes after treatment of localised prostate cancer with focal therapy using various energy sources: protocol for a mixed-methods study

IntroductionFocal therapy has emerged as a promising treatment option for men with localised prostate cancer. However, most of the evaluation of postoperative function has taken place at a relatively high,...

Focal irreversible electroporation for localized prostate cancer management: prospective assessment of efficacy and safety.

article: Focal irreversible electroporation for localized prostate cancer management: prospective assessment of efficacy and safety - Minerva Urologica e Nefrologica 2020 October;72(5):644-5 - Minerva Medica - Journals

V107 - Focal irreversible electroporation for management of localized prostate cancer. Initial results

V107 - Focal irreversible electroporation for management of localized prostate cancer. Initial results

Impact of 68Ga-PSMA-11 PET/CT on staging and management of prostate cancer patients in various clinical settings.

26 Background: The goal of this study was to determine the impact of 68Ga-PSMA-11 PET/CT on initial and subsequent management decisions in a cohort of PCa patients referred for various indications excluding the two main classical indications: BCR and pre-surgical staging. Methods: This is a prospective study of 197 patients that aimed to determine the impact of 68Ga-PSMA-11 PET/CT on PCa stage and management. Indications for PSMA PET/CT were initial staging of non-surgical candidates (30 patients) and re-staging after definitive treatment (n=168). The re-staging cohort comprised: patients re-staged with known advanced metastatic disease (n=103), after androgen deprivation therapy only (n=16), after surgery with serum PSA levels &lt;0.2 ng/ml (n=13), after radiation therapy (RT) not meeting the Phoenix criteria (n=22) and after other primary local treatments [i.e. HIFU, focal laser ablation, cryoablation, hyperthermia or irreversible electroporation] (n=13). Patients with BCR and candidates for curative surgery were excluded. Impact on management was assessed using pre- and post-PET questionnaires completed by referring physicians, electronic chart review and/or patient telephone encounters. Results: PSMA PET/CT changed disease stage in 135/197 (69%) patients (38% up-stage, 30% down-stage and no changes in stage in 32%). Management was affected in 104/182 (57%) patients. PSMA PET/CT had its greatest management impact in patients who were re-staged after RT. Conclusions: PSMA PET/CT has a profound impact on stage and management of PCa patients outside of the two main classical indications (BCR and presurgical staging) across all examined clinical scenarios. Clinical trial information: NCT04050215.