Focal irreversible electroporation as primary treatment for localized prostate cancer

Bos, Willemien van den; Scheltema, Matthijs J.; Siriwardana, Amila; Kalsbeek, Anton M.F.; Thompson, James; Ting, Francis; Böhm, Maret; Haynes, Anne‐Maree; Shnier, Ron; Delprado, Warick; Stricker, Phillip D.

doi:10.1111/bju.13983

Cited by 86 publications

(72 citation statements)

References 18 publications

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“…The importance of a larger treatment margin was exemplified in a prospective cohort study of 123 patients with predominantly intermediate-risk prostate cancer and a median follow-up of 36 months [30,31]. In this study, no Clavien-Dindo Grade III-IV adverse effects occurred.…”

Section: Clinical Trials Of Ire In Prostate Cancermentioning

confidence: 78%

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Irreversible electroporation (IRE): a narrative review of the development of IRE from the laboratory to a prostate cancer treatment

et al. 2019

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Introduction Whilst whole‐gland radical treatment is highly effective for prostate cancer control, it has significant impact on quality of life and is unnecessary ‘over‐treatment’ in many men with screening‐detected prostate cancer. Improvements in prostate biopsy and imaging have led to increased interest in partial gland ablation to reduce treatment‐related morbidity. Several energies for focal ablation have been trialled. Irreversible electroporation (IRE) is a novel technology that ablates tissue by delivering direct current between electrodes. This narrative review documents the history of electroporation including its scientific basis, early data from pre‐clinical animal studies, and contemporary clinical outcomes from the use of IRE in prostate cancer. Methods A literature search using the Medical Literature Analysis and Retrieval System Online (MEDLINE), the Excerpta Medica dataBASE (EMBASE), PubMed and Google Scholar was undertaken to identify historical perspectives and current clinical data relating to IRE for prostate cancer. Results The history of electroporation and its implementation as a prostate cancer treatment was following the basic scientific principles, in vitro data, then animal studies, and now short‐ to medium‐term clinical cohorts in humans. The results of IRE on >283 patients have been published in several papers, with preserved rates of (pad‐free) continence in 91–100% of men and preserved erectile function in 79–100% of men. In‐field recurrence rates range from 0% to 33%. The current state of evidence for IRE for the treatment of primary and salvage prostate cancer is considered as Idea, Development, Exploration, Assessment, Long‐term follow‐up (IDEAL) stage 2B. Conclusions IRE is a new focal ablative technology for the treatment of localised prostate cancer in carefully selected men. Published cohorts report encouraging short‐term oncological and functional outcomes; however, longer‐term data are needed to validate this treatment before it can be recommended for widespread clinical use.

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Section: Clinical Trials Of Ire In Prostate Cancermentioning

confidence: 78%

“…Another recent prospective cohort study of 30 patients, with a median follow-up of 20 months, reported similar oncological and function outcomes [32]. The results of studies applying IRE are shown in Table 2 [22][23][24][25][26][27][30][31][32]37,48].…”

Section: Clinical Trials Of Ire In Prostate Cancermentioning

confidence: 85%

Irreversible electroporation (IRE): a narrative review of the development of IRE from the laboratory to a prostate cancer treatment

et al. 2019

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“…The initial feasibility trials with IRE demonstrated the safety and feasibility of this new technique with low patient morbidity and good short-term oncologic control (7)(8)(9)(10)(11)(12). IRE ablates tumor tissue by delivering a direct high-voltage current between a pair of needle electrodes (13).…”

Section: Resultsmentioning

confidence: 99%

“…Since all the prostate segments can be encompassed within the needle configurations of IRE, oncologic control should not theoretically differ between the prostate segments. Failures after IRE were recently proven to be significantly dependent on the applied safety margin and/or system errors that occurred during the treatment (12).…”

Section: Resultsmentioning

confidence: 99%

“…We choose to exclude the oncologic control per prostate segment based on previous results from an ablation and resection study (14). Moreover, infield oncologic failures following IRE were proven to be significantly dependent on the applied safety margin and/ or system errors occurring during IRE (12). In this cohort, 7 patients had infield residual disease, including all different prostate segments (anterior, posterior, apex, mid, base), justifying our exclusion of oncologic analysis.…”

Section: Discussionmentioning

confidence: 99%

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Impact on genitourinary function and quality of life following focal irreversible electroporation of different prostate segments

Scheltema

Chang

Bos

et al. 2018

Diagn Interv Radiol

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Extended Focal Ablation of Localized Prostate Cancer With High-Frequency Irreversible Electroporation

et al. 2022

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IMPORTANCEFocal therapy of prostate cancer must balance the oncologic outcome and functional outcome. High-frequency irreversible electroporation (H-FIRE) can destroy cancer cells while selectively preserving surrounding nerves and blood vessels, but no clinical trials have been conducted, to our knowledge. OBJECTIVE To evaluate the efficacy and safety of H-FIRE in the treatment of localized prostate cancer (PCa). DESIGN, SETTING, AND PARTICIPANTS This was a single-group, objective performance criteria, nonrandomized controlled trial. Recruitment began on May 2, 2018, and ended March 27, 2019. The follow-up duration was 6 months. This was a multicenter trial conducted at 4 tertiary teaching hospitals in China. Patients with low or intermediate risk of biochemical recurrence of localized and locally advanced PCa were eligible. Key inclusion criteria were serum prostate-specific antigen (PSA) level less than 20 ng/mL, clinical stage of T2c or less, and Gleason score of 7 or less. Data were analyzed from January 20 to February 20, 2021. INTERVENTION H-FIRE ablation of all lesions identified with biopsy. MAIN OUTCOMES AND MEASURESThe primary end point was 6-month clinically significant PCa (csPCa), which was defined as any biopsy core with Gleason score of greater than or equal to 7, or Gleason score of 6 plus maximum cancer core length of greater than 3 mm or an increase from the original cancer burden. Secondary outcomes were calculated in patients who actually received H-FIRE treatment.RESULTS A total of 117 patients (median [IQR] age, 67 [62-73] years) were recruited from 4 centers, and 109 patients (27 [24.8%] low risk and 82 [75.2%] intermediate risk) actually received H-FIRE. Median (IQR) PSA level was 9.0 (6.0-12.7) ng/mL. Among the 100 patients who underwent biopsy at 6 months, the 6-month csPCa rate was 6.0% (95% CI, 2.2%-12.6%; P < .001; 1 in the treatment zone and 5 outside the treatment zone). Superiority criteria vs the historical control of 20% was achieved. PCa was detected in 14 patients, with a Gleason score of 7 in 2 patients and 6 in the remaining 12 patients. At 6 months, median (IQR) PSA level was 1.08 (0.4-3.2) ng/mL, median (IQR) International Prostate Symptom Score was 4.5 (2.0-9.5), and median (IQR) International Index of Erectile Function 5 score was 2.0 (0.5-12.5). Superiority vs the 20% historical control was also met in the subgroup analysis that only included the 57 patients with Gleason score of 7 at baseline (3.5% 6-month csPCa; 95% CI, 0.4%-12.1%). CONCLUSIONS AND RELEVANCEThe rate of 6-month csPCa with H-FIRE ablation was lower than the historical control using other energy platforms.

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Focal irreversible electroporation as primary treatment for localized prostate cancer

Abstract: Our data support the safety and feasibility of focal IRE as a primary treatment for localized PCa with effective short-term oncological control in carefully selected men.

Cited by 86 publications

References 18 publications

Irreversible electroporation (IRE): a narrative review of the development of IRE from the laboratory to a prostate cancer treatment

Irreversible electroporation (IRE): a narrative review of the development of IRE from the laboratory to a prostate cancer treatment

Impact on genitourinary function and quality of life following focal irreversible electroporation of different prostate segments

Extended Focal Ablation of Localized Prostate Cancer With High-Frequency Irreversible Electroporation

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