Feasibility and safety of targeted focal microwave ablation of the index tumor in patients with low to intermediate risk prostate cancer: Results of the FOSTINE trial

Nicolas Barry Delongchamps, Alexandre Schull, Julien Anract, Jean-Paul Abecassis, Marc Zerbib, Mathilde Sibony, Léa Jilet, Hendy Abdoul, Vincent Goffin, Michaël Peyromaure, Nicolas Barry Delongchamps, Alexandre Schull, Julien Anract, Jean-Paul Abecassis, Marc Zerbib, Mathilde Sibony, Léa Jilet, Hendy Abdoul, Vincent Goffin, Michaël Peyromaure

Abstract

Objective: To assess the feasibility, safety and precision of organ-based tracking (OBT)-fusion targeted focal microwave ablation (FMA), in patients with low to intermediate risk prostate cancer.

Patients and method: Ten patients with a visible index tumor of Gleason score ≤3+4, largest diameter <20mm were included. Transrectal OBT-fusion targeted FMA was performed using an 18G needle. Primary endpoint was the evidence of complete overlap of the index tumor by ablation zone necrosis on MRI 7 days after ablation. Urinary and sexual function were assessed with IPSS, IIEF5 and MSHQ-EjD-SF. Oncological outcomes were assessed with PSA at 2 and 6 months, and re-biopsy at 6 months.

Results: Median [IQR] age was 64.5 [61-72] years and baseline PSA was 5 [4.3-8.1] ng/mL. Seven (70%) and 3 (30%) patients had a low and intermediate risk cancer, respectively. Median largest tumor axis was of 11 [9.0-15.0] mm. Median duration of procedure was of 82 [44-170] min. No patient reported any pain or rectal bleeding, and all 10 patients were discharged the next day. Seven days after ablation, total necrosis of the index tumor on MRI was obtained in eight (80% [95%CI 55%-100%]) patients. One patient was treated with radical prostatectomy. Re-biopsy at 6 months in the other 9 did not show evidence of cancer in 4 patients. IPSS, IIEF-5 and MSHQ-EjD-SF were not statistically different between baseline and 6 months follow up.

Conclusions: OBT-fusion targeted FMA was feasible, precise, and safe in patients with low to intermediate risk localized prostate cancer.

Conflict of interest statement

I have read the journal’s policy and the authors of this manuscript have the following competing interests: N Barry Delongchamps is Consultant for Koelis. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. Flow chart.
Fig 1. Flow chart.
Fig 2. Index tumor location at baseline…
Fig 2. Index tumor location at baseline in the 10 patients before targeted FMA.
Schematic view of index tumor location. Index tumors have been represented with a 1:1 scale on a prostate with 4 cm height (antero-posterior axis), 6 cm width (lateral axis).
Fig 3
Fig 3
Elastic fusion and ablation process in patient N°3: MRI prostate contours were delineated and the target (index tumor) was defined on the station (A). Prostate contours were then delineated on ultrasound images (B), and elastic MRI/Ultrasound fusion was performed (C). This allowed an OBT-Fusion registration of the microwave applicator and measurement on ultrasound of the expected ablation (D), based on ex-vivo predictive ablation charts. The site of ablation was then visualized 7 days after ablation on Dynamic Contrast Enhanced MRI (E).
Fig 4. Assessment of index tumor coverage…
Fig 4. Assessment of index tumor coverage by necrosis 7 days after ablation in patients 1, 2, 4 and 6: Preoperative MRI the index tumor (arrow).
Postoperative DCE-T1 MRI showing total necrosis of index tumor (arrow).

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