This randomized clinical trial compares data for patients who underwent ablation therapy to determine the effects of focal vs extended irreversible electroporation on early oncological control as indicated by presence on follow-up biopsy of clinically significant prostate cancer.
Key Points
Question
What is the effect of focal vs extended irreversible electroporation (IRE) on early oncological control for patients with localized low- or intermediate-risk prostate cancer?
Findings
In this randomized clinical trial with 106 patients, there was no significant difference in presence of clinically significant prostate cancer between the focal and extended IRE ablation groups on follow-up biopsy at 6 months.
Meaning
This study found that focal IRE ablation therapy may provide acceptable oncological outcomes while preserving quality of life among patients with localized low- or intermediate-risk prostate cancer.
Abstract
Importance
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.
Objective
To evaluate the effect of focal vs extended IRE on early oncological control for patients with localized low- and intermediate-risk prostate cancer.
Design, Setting, and Participants
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.
Main Outcomes and Measures
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.
Results
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.
Conclusions and Relevance
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.
Trial Registration
ClinicalTrials.gov Identifier: NCT01835977
Introduction
Focal therapy for prostate cancer uses different sources of energy to treat targeted cancerous areas of the gland, thereby avoiding or limiting damage to surrounding structures and aiming to preserve urinary and erectile function.1,2 Irreversible electroporation (IRE) is a tumor ablation technique that uses nonthermal, high-voltage, low-energy electrical pulses between electrodes to create permanent pores in the cell membrane, which leads to a disruption in cellular homeostasis that triggers cell death.3,4
We conducted a multicenter randomized clinical trial comparing focal and extended IRE ablation therapy for patients with localized low- or intermediate-risk prostate cancer. In this study, we present oncological results from short-term and mid-term follow-up.
Methods
Study Design
This multicenter randomized clinical trial involved 5 centers in Europe. The study was conducted in accordance with good clinical practices and the Declaration of Helsinki and was approved by the institutional review board of the Academic Medical Center in Amsterdam. The protocol is registered with the Dutch Central Committee on Research Involving Human Subjects (NL50791.018.14) and ClinicalTrials.gov (NCT01835977). Patients provided written informed consent. Protocols and related details appear in Supplements 2 through 5. Reporting adheres to the Consolidated Standards of Reporting Trials (CONSORT) guideline.
Patient Selection and Randomization
Transperineal 3-dimensional, template mapping biopsies were performed to identify and enroll patients with unilateral, histopathologically confirmed, organ-confined prostate cancer. A full list of inclusion and exclusion criteria were published elsewhere.3
Patients were randomized to receive focal or extended IRE ablation with an allocation ratio of 1:1. Randomization was performed using the web-based data management system of the Clinical Research Office of the Endourological Society and stratified by age (≤60 vs >60 years), Gleason score (6 vs 7), and International Index of Erectile Function score (≤45 vs >45).
Treatment Protocol
All patients underwent a multiparametric magnetic resonance imaging (mpMRI) scan in supine position on a 1.5-T Avanto MRI scanner (Siemens Healthcare) using an integrated endorectal-pelvic phased array coil (Medrad). The images were evaluated by specialized uroradiologists. Extensive transperineal, 3-dimensional, template-mapping biopsies were performed to locate the tumor.
This study used the AngioDynamics NanoKnife IRE system, the first commercially available device to our knowledge. The focal ablation group underwent an ablation of the area of the prostate that had positive biopsy cores. The extended ablation group underwent a zonal ablation (Figure 1). Details of the treatment protocol were described by Scheltema et al.3 In brief, during the IRE ablation, up to 6 electrode needles were placed into the ablation zone under ultrasound image guidance. Ninety consecutive pulses of high voltage (1500 V/cm) with a direct current between 20 and 50 A were delivered. The total procedure time, including administration of general anesthesia, was approximately 1 hour.
Figure 1. Electroporation Zones of the Prostate.
The focal ablation group underwent an ablation of the area of the prostate with positive biopsy cores. The extended ablation group underwent a zonal ablation.
Study Outcomes, Follow-up, and Treatment Failure
The primary objective was to evaluate differences in adverse events and quality of life among patients treated with image-guided IRE for focal or extended ablation. The outcomes are presented elsewhere.5 The secondary objective was to evaluate the oncological efficacy of focal and extended ablation. Here we report those results as reflected by presence of clinically significant prostate cancer (defined as International Society of Urological Pathology grade ≥2) on transperineal template-mapping prostate biopsy at 6 months after IRE ablation.
All related data were collected, including patient characteristics, procedure record, and oncological results. During follow-up visits at 6 months after IRE ablation, all patients underwent MRI and transperineal template biopsy.3
In-field treatment failure was defined as persistent cancer of similar or different grade in the ablated area. Low-grade, low-volume tumor foci (<3 mm ISUP grade 1) found out of field was not considered treatment failure.
Sample Size Calculation
Based on the primary outcome, the sample size was powered on a common event, erectile dysfunction. This was based on absolute erectile function (question 2 of the International Index of Erectile Function questionnaire) and calculated by means of a 2-sample proportions Pearson χ2 test (1-sided). Ahmed et al6,7,8,9 performed 3 studies with concurrent focal ablation (high-intensity focused ultrasound), comparable ablative scenarios, similar patient population, and the same primary objectives. Based on this comparable research, we estimated that focal treatment would result in 15% absolute erectile dysfunction and extended treatment in 40% absolute erectile dysfunction.
With an α level of .05 and power of 0.80, the required sample size was 39 men in each group. We adjusted the sample size to allow for 35% of men (>50 years old) having poor baseline erectile function in general population,9 and therefore, we aimed to recruit at least 106 men total.
Statistical Analysis
The Shapiro-Wilk test was used for the assessment of normality of distribution. The Mann-Whitney U test was performed to compare prostate-specific antigen (PSA) values between the 2 groups. The χ2 test was used to compare MRI and biopsy results. A 2-sided P value less than .05 was considered statistically significant. Data were analyzed from September 2021 to July 2022, and statistical analyses were performed using SPSS version 27 for Windows (IBM).
Results
Baseline Characteristics
From July 2015 to February 2020, 106 patients were recruited for this study; 51 patients received focal ablation and 55 patients received extended ablation. Median (IQR) follow-up time was 30 months (24-48). The CONSORT diagram is shown in Figure 2.
Figure 2. Consolidated Standards of Reporting Trials (CONSORT) Diagram.
IRE indicates irreversible electroporation.
The demographic and baseline characteristics are presented in Table 1. There was no significant difference between the 2 groups in terms of age, PSA level, imaging evaluation, Gleason score, tumor T stage, number of positive cores, and procedure time. More IRE electrodes were used in the extended ablation group than in the focal ablation group.
Table 1. Baseline Characteristics and Perioperative Outcomes of the Patients.
| Ablation group, No. (%) | P value | ||
|---|---|---|---|
| Focal (n = 51) | Extended (n = 55) | ||
| Age, median (IQR), y | 64 (58-67) | 64 (57-68) | .89 |
| PSA, median (IQR), ng/mL | 5.93 (4.34-8.96) | 6.05 (4.5-8.64) | .82 |
| Imaging evaluation | .28 | ||
| MRI | 4 (7.8) | 6 (10.9) | |
| mpMRI | 47 (92.2) | 48 (87.3) | |
| ISUP grade | .75 | ||
| 1 | 28 (54.9) | 32 (58.2) | |
| 2 | 21 (41.2) | 21 (38.2) | |
| 3 | 2 (3.9) | 2 (3.6) | |
| T stage | .89 | ||
| cT1c | 45 (88.2) | 49 (89.1) | |
| cT2a | 6 (11.8) | 6 (10.9) | |
| No. of positive cores | .22 | ||
| 1 | 18 (35.3) | 21 (38.2) | |
| 2 | 8 (15.7) | 17 (30.9) | |
| ≥3 | 25 (49.0) | 17 (30.9) | |
| Procedure time, median (IQR), min | 50 (35.5-60) | 47 (40-60) | .72 |
| No. of IRE electrodes, median (IQR) | 3 (3-4) | 4 (3-6) | .04 |
Abbreviations: IRE, irreversible electroporation; ISUP, International Society of Urological Pathology; mpMRI, multiparametric magnetic resonance imaging; PSA, prostate-specific antigen.
Early Oncological Results
Transperineal template-mapping prostate biopsy at 6 months after IRE was performed for 48 patients in the focal ablation group and 53 patients in the extended ablation group. Prostate cancer was found in 27 of 48 patients (56.3%) in the focal ablation group and 23 of 53 patients (43.4%) in the extended ablation group, and clinically significant prostate cancer (ISUP grade ≥2) 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 between the 2 groups.
Among these patients, 15 of 48 patients (31.3%) in the focal ablation group and 14 of 53 patients (26.4%) in the extended ablation group had 1 positive biopsy core. In the focal ablation group, 17 patients (35.4%) had positive cores outside of the treated area, only 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. By contrast, 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 (P = .64). According to the protocol, treatment failure was experienced by 12 of 48 patients (25%) in the focal ablation group and 12 of 53 patients (22.6%) in the extended ablation group (P = .82). The results are summarized in Table 2.
Table 2. Repeated Biopsy Results at the 6-Month Follow-up.
| Ablation group, No. (%) | P value | ||
|---|---|---|---|
| Focal (n = 48) | Extended (n = 53) | ||
| Clinically significant prostate cancer | 9 (18.8) | 7 (13.2) | .29 |
| Any-grade prostate cancer | 27 (56.3) | 23 (43.4) | .20 |
| ISUP grade | |||
| 1 | 18 (37.5) | 16 (30.2) | |
| 2 | 7 (14.6) | 3 (5.7) | |
| 3 | 1 (2.1) | 4 (7.5) | |
| ≥4 | 1 (2.1) | 0 | |
| No. of positive cores | .11 | ||
| 1 | 15 (31.3) | 14 (26.4) | |
| 2 | 6 (12.5) | 8 (15.1) | |
| ≥3 | 6 (12.5) | 1 (1.9) | |
| Location of positive cores | .09 | ||
| In the treated area | 3 (6.3) | 9 (17.0) | |
| Out of the treated area | 17 (35.4) | 10 (18.9) | |
| In and out of the treated area | 5 (10.4) | 2 (3.8) | |
| Treatment failurea | 12 (25.0) | 12 (22.6) | .82 |
Abbreviation: ISUP, International Society of Urological Pathology.
Treatment failure was defined as persistent cancer of similar or different grade in the treated area or high volume (≥3 mm) ISUP grade 1 tumor foci or ISUP grade 2 tumor foci found in the untreated area.
PSA Value
Changes in PSA levels during follow-up were almost identical in the 2 groups. They increased in the first 24 hours after the procedure and then decreased over the subsequent 2 weeks. After the 1-month follow-up, values were lower than baseline and subsequently remained similar (Figure 3).
Figure 3. Prostate-Specific Antigen (PSA) Values at Baseline and Follow-up.
MRI Scan Results
At the 6-month follow-up, 50 patients in the focal ablation group and 53 patients in the extended ablation group received an MRI or mpMRI scan. The images showed that among 43 of 50 patients (86%) in the focal ablation group and 47 of 53 patients (88.7%) in the extended ablation group, the previous lesions treated with IRE were resolved or no suspicious lesions were found (eTable 1 and eFigures 1 and 2 in Supplement 1).
MRI Scan Results Related to Biopsy Outcomes
In each of the focal and extended ablation groups, among patients with MRI showing resolved or no lesions, only 6 cases of clinically significant prostate cancer were detected (12.8% and 11.5%, respectively) (eTable 2 in Supplement 1). By contrast, in the areas where MRI showed persistent or responsive but not resolved lesions, tumors were detected in all but 1 case.
Treatment Failure Rates
In the focal ablation group, the treatment failure rate in the apex, middle, and base areas was 23.1%, 33.3%, and 16.7%, respectively (P = .65). In the extended ablation group, the treatment failure rate in these areas was 28%, 18.8%, and 14.3%, respectively (P = .67) (eTable 3 in Supplement 1). For both groups, the treatment failure rate in the apex (25.5%) and middle areas (25%) was higher than in the base area (15.4%), even though there was no statistical difference (P = .99). Neither group showed an association between treatment failure rate and number of positive cores at initial biopsy (eTable 4 in Supplement 1).
Neither group showed an association between treatment failure rate and ISUP grade at the baseline (eTable 5 in Supplement 1). For clinically significant cancer, the treatment failure rate was 27.3% overall. However, for ISUP grade 1-3 tumors, only 9.4%, 12.5%, and 0% of clinically significant tumors were detected, respectively, in the treated areas (eTable 6 in Supplement 1).
The treatment failure rate at each of the 5 European centers was 27.3% (3 of 11 patients), 22.8% (13 of 57 patients), 33.3% (3 of 9 patients), 42.9% (3 of 7 patients), and 15.4% (2 of 13 patients). The rate was not associated with the patient volume at each center.
Discussion
While 46 of 106 patients (43.4%) had clinically significant cancer at baseline and 50 of 101 patients (49.5%) had positive biopsy results at 6 months, only 16 of 101 patients (15.8%) had clinically significant cancer at the 6-month biopsy. Moreover, for 34 of 50 patients (68%) with cancer detected at 6 months, the positive cores were not in the treated area. This finding suggests IRE could provide promising oncological control as a focal therapy for localized prostate cancer. But this also illustrates that clinical assessment using current standards has significant limitations.
Focal therapy is gaining interest as an option to treat low-volume, low- and intermediate-risk localized prostate cancer. The question remains whether this approach can provide acceptable oncological control while preserving quality of life. For decades, different types of energy sources in focal therapy have been studied, including IRE, high-intensity focused ultrasound, cryotherapy, photodynamic therapy, focal laser ablation or laser interstitial thermotherapy, radiofrequency ablation, and focal brachytherapy.2 Reports describe rates of clinically significant cancer in the treated area as a median of 8.5% for IRE, 14.7% for high-intensity focused ultrasound, 15% for cryoablation, 10% for photodynamic therapy, 17% for focal laser ablation, 20% for radiofrequency ablation, 0% for focal brachytherapy, and 60% for prostatic artery embolization.2 However, the treatment protocols vary among different studies, and the follow-up was rather short.
Several studies have reported early oncological results of IRE. The rate of clinically significant cancer in the treated area was reported by 4 studies as a median of 8.5% (range, 0%-33%).2 In our study, clinically significant cancer was found in the treated area in 10 of 101 patients (9.9%).
In this study, detecting any tumors with an ISUP grade of 2 or higher in the untreated area was also designated as treatment failure. The treatment failure rate was 23.8% (24 of 101 patients) in this study, which is due not only to persistent cancer in the treated area, but also to tumors detected in the untreated area. Including only tumors detected in the treated area would result in a lower rate of treatment failure. The rate of cancer considered clinically significant that was found in the untreated area was equal to that in the treated area. This fact highlights the importance of baseline biopsy and patient selection.
Biopsy approach varies among different studies of focal therapy.1 Transperineal mapping biopsies were used in our study, irrespective of patients undergoing MRI scan before biopsies. Many tumors were missed in the initial biopsy, causing an increase in treatment failure rate in our study. It is also a general limitation for all the prostate cancer focal therapy techniques. This study was started 7 years ago. At that time, the transperineal prostate biopsy technique might have been limited. Prostate cancer detection and visualization was significantly improved by MRI, which has been shown to reliably identify clinically significant cancer.10 Hence, some studies suggested that MRI-targeted biopsy in combination with systematic biopsy can replace transperineal mapping biopsies.11,12 However, each biopsy technique may miss tumors inevitably. One study evaluated the dominant tumor progression across serial biopsies for patients receiving active surveillance, showing that even with MRI-targeted biopsy and additional systematic biopsy, up to 21% unfavorable cancers were detected in the contralateral lobe during follow-up biopsies, which may reflect the limitation of biopsy and also reflects that prostate cancer often presents as a multifocal tumor.13
In our study, MRI showed good accuracy to detect residual clinically significant prostate cancer following IRE. In another study, 50 patients underwent IRE and received follow-up mpMRI at 6 months and transperineal template-mapping biopsy at 12 months. The sensitivity, specificity, positive predictive values, and negative predictive values of the infield regions of interest were 38%, 86%, 33%, and 88%, respectively, for clinically significant prostate cancer (ISUP grade ≥2 or ≥1 with a maximum cancer core length ≥4 mm).14 A recently published study showed that the sensitivity, specificity, positive predictive values, and negative predictive values of mpMRI to detect whole-gland residual clinically significant prostate cancer (ISUP grade ≥2 or ≥1 with a maximum cancer core length ≥4 mm) were 35.8%, 82.0%, 47.1%, and 74.1%, respectively.15 Their studies indicated that the diagnostic accuracy of mpMRI to detect residual clinically significant tumor after IRE was insufficient. Significant prostate volume and lesion orientation changes occur after partial gland ablation. MRI is limited by the abundance of treatment artifacts, lack of standardization for acquisition and MRI reporting after treatment, and lack of familiarity with postfocal therapy MRI among radiologists.16 A new postfocal therapy Prostate Imaging Reporting and Data System would guide the risk assessment and the management of residual tumors.17
Patient selection is critical for IRE and focal therapy. Biopsy approach should be further studied and improved to detect all the cancers in the gland as far as possible. As shown in our study, tumors located in the base area seem more likely to be treated successfully compared with those in the apex and middle areas. It is important to emphasize that treatment success rate was not associated with tumor grade in our study, suggesting that focal therapy need not be not confined to low-risk prostate cancer. In fact, for the past 5 years, 51% of patients who underwent focal therapy had Gleason 7 disease, with a stable small proportion of men with Gleason 8 tumor.2,16 Because some men with intermediate-risk prostate cancer could still be candidates for active surveillance, focal therapy may be a promising option for those patients with a high risk of cancer progression.13 In our study, treatment success was not related to the patient volume of the center, indicating that the learning curve for the IRE technique may be short.
Limitations
To our knowledge, this is the first prospective randomized study comparing focal and extended ablation in patients with localized prostate cancer. However, this study is limited by the lack of long-term follow-up for oncological results. The sample size is relatively small and primarily powered for changes in quality-of-life issues. So it might not be adequately powered to detect small differences between the 2 groups on oncological results. Moreover, the treatment options and results for patients with persistent tumor were limited; these results will be reported when the data matures. This study was initiated in 2015 when it was recommended to assess potential candidates in performing transperineal template biopsies. In the meantime, the biopsy strategy has changed to using mpMRI-guided targeted biopsies plus systematic biopsies. However, this change does not impair the validity of the data presented but merely reflects the rapid change in imaging and related diagnostic assessment. Also, in earlier days, it was considered good practice to only treat low-risk disease, and therefore, a considerable number of ISUP grade 1 tumors are included. At present, that indication has been extended and is reflected in a significant number of patients with intermediate-risk disease. Finally, there was no central review of the mpMRI readings or pathology outcome.
Conclusions
This study found that IRE ablation achieved promising oncological control in men with localized low- or intermediate-risk prostate cancer, and there was no significant difference between focal and extended ablation in their effect on the oncological results. Focal ablation therapy may be a promising option for those patients with a high risk of cancer progression.
eTable 1. The MRI scan results
eTable 2. The MRI scan results related to the biopsy outcomes
eTable 3. Treatment failure rate in different tumor position
eTable 4. Treatment failure rate among patients with different positive cores at baseline biopsy
eTable 5. Treatment failure rate among patients with different ISUP group at baseline biopsy
eTable 6. The change of biopsy results in the treated area after treatment
eFigure 1. The changes on MRI before and after IRE treatment
eFigure 2. Lesion resolved on the MRI
Trial protocol 2015
Trial protocol 2019
Medical ethics approval
Protocol amendments
Data sharing statement
References
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
eTable 1. The MRI scan results
eTable 2. The MRI scan results related to the biopsy outcomes
eTable 3. Treatment failure rate in different tumor position
eTable 4. Treatment failure rate among patients with different positive cores at baseline biopsy
eTable 5. Treatment failure rate among patients with different ISUP group at baseline biopsy
eTable 6. The change of biopsy results in the treated area after treatment
eFigure 1. The changes on MRI before and after IRE treatment
eFigure 2. Lesion resolved on the MRI
Trial protocol 2015
Trial protocol 2019
Medical ethics approval
Protocol amendments
Data sharing statement