Combination of Radiation Therapy and Irreversible Electroporation for Intermediate-Risk Prostate Cancer (RTIRE): A Phase 1 Trial.

Authors

Timothy D McClure, Shu Wang, Karla V Ballman, Marshall Diven, Joseph R Osborne, Elisabeth O'Dwyer, Jennifer Piscopo, Francesca Khani, Ariel Marciscano, Bashir Al Hussein Al Awamlh, Christopher Barbieri, Himanshu Nagar

Published in

Radiology. Volume 320. Issue 1. Pages e250848.

Abstract

Background Irreversible electroporation (IRE) is a nonthermal local therapy for prostate cancer (PCa). However, the feasibility, outcomes, and safety of reduced-dose radiation therapy (RT) following IRE (RTIRE) for the treatment of intermediate-risk PCa are unknown. Purpose To assess the feasibility of RTIRE for the treatment of intermediate-risk PCa. Materials and Methods This was a prospective study from May 2022 to April 2024 and included participants with intermediate-risk PCa with a focal index lesion (grade group 2 or 3 disease) visible at MRI. Participants underwent RTIRE (to 32.5 Gy in five fractions) with follow-up at 3, 6, 9, and 12 months. The primary end point was enrollment feasibility. Secondary end points included early oncologic control, quality-of-life outcomes, and adverse events. The Wilcoxon rank-sum test was used to compare continuous values at different time points. Results A total of 10 men (median age, 66 years [IQR, 61-72 years]) successfully completed RTIRE. At 12 months, no residual disease was detected at biopsy in 100% (10 of 10) of participants. Median prostate-specific antigen level decreased from baseline (7.65 ng/mL) to 3 months (0.98 ng/mL; P = .002) and remained stable at 12 months (0.56 ng/mL; P = .002 vs baseline). Median Expanded Prostate Cancer Index Composite for Clinical Practice score increased from baseline (3.5 [IQR, 3-8]) to 6 months (13 [IQR, 9-19]; P = .02), returning to near baseline at 12 months (6 [IQR, 5-15.75]; P = .05). International Index of Erectile Function score decreased from baseline (median, 23.5) to 6 months (median, 12; P = .02), with recovery by 12 months (median, 22; P = .16 vs baseline). Median International Prostate Symptom Score was stable at 12 months (P = .56 vs baseline). No severe adverse events occurred (100% [27 of 27] of adverse events were grade 1 or 2). Conclusion Treatment of participants with intermediate-risk PCa with RTIRE was feasible and showed no clinically meaningful decline in patient-reported outcomes and no severe adverse events. Clinical trial registration no. NCT05345444 © RSNA, 2026 Supplemental material is available for this article. See also the editorial by Nezami and Unger in this issue.

PMID:
42517770
Bibliographic data and abstract were imported from PubMed on 28 Jul 2026.

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