RTIRE (IRE focal ablation + reduced-dose RT) yields 100% negative 12‑mo biopsy in intermediate‑risk prostate cancer

RTIRE combines irreversible electroporation (IRE), a nonthermal focal ablation approach, followed by reduced-dose external-beam radiation (32.5Gy in 5 fractions) to treat MRI-visible grade group 2–3 index lesions in intermediate-risk prostate cancer in a prospective Phase 1 feasibility study (n=10; May 2022–Apr 2024; NCT05345444). At 12 months, post-treatment biopsy showed no residual disease in 100% (10/10) and median PSA fell from 7.65ng/mL to 0.98ng/mL at 3 months (P=.002) and 0.56ng/mL at 12 months (P=.002 vs baseline); however, this is a single-arm, very small study with short follow-up vs standard definitive RT/SBRT regimens (commonly 36.25Gy/5fx SBRT or ~60Gy/20fx moderate hypofractionation, where long-term biochemical control—not 12‑mo biopsy negativity—is the benchmark). Patient-reported outcomes worsened transiently (EPIC‑CP median 3.5 to 13 at 6 mo, P=.02; IIEF median 23.5 to 12 at 6 mo, P=.02) but largely recovered by 12 months (EPIC‑CP 6, P=.05 vs baseline; IIEF 22, P=.16), IPSS remained stable (P=.56), and all adverse events were grade 1–2 (27/27; no grade ≥3).