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

Publication ,  Journal Article
George, AK; Miocinovic, R; Patel, AR; Lomas, DJ; Correa, AF; Chen, DYT; Rastinehad, AR; Schwartz, MJ; Uchio, EM; Sidana, A; Helfand, BT; Yu, A ...
Published in: Cancers (Basel)
June 8, 2024

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.

Duke Scholars

Published In

Cancers (Basel)

DOI

ISSN

2072-6694

Publication Date

June 8, 2024

Volume

16

Issue

12

Location

Switzerland

Related Subject Headings

  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
 

Citation

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MLA
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George, A. K., Miocinovic, R., Patel, A. R., Lomas, D. J., Correa, A. F., Chen, D. Y. T., … Coleman, J. A. (2024). A Description and Safety Overview of Irreversible Electroporation for Prostate Tissue Ablation in Intermediate-Risk Prostate Cancer Patients: Preliminary Results from the PRESERVE Trial. Cancers (Basel), 16(12). https://doi.org/10.3390/cancers16122178

Published In

Cancers (Basel)

DOI

ISSN

2072-6694

Publication Date

June 8, 2024

Volume

16

Issue

12

Location

Switzerland

Related Subject Headings

  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis