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.

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.

Prebiopsy magnetic resonance imaging and prostate cancer detection: comparison of random and targeted biopsies.

PURPOSE: We compared the accuracy of visual targeted biopsies vs computerized transrectal ultrasound-magnetic resonance imaging registration using a rigid (Esaote®, nondeformable) or elastic (Koelis®, deformable) approach. MATERIALS AND METHODS: A total of 391 consecutive patients with suspected localized prostate cancer were prospectively included in analysis. All patients underwent prostate magnetic resonance imaging, followed by 10 to 12-core random prostate biopsies. When magnetic resonance imaging detected suspicious findings, targeted biopsy was performed, including visual, rigid system and elastic system targeted biopsies in the first 127 patients, the next 131 and the last 133, respectively. Cancer detection rates were assessed by conditional logistic regression. Targeted biopsies alone and random biopsies were further compared for the amount of tissue sampled and microfocal cancer detection, the latter defined as a single core with 5 mm or less of Gleason 6 cancer. RESULTS: Patient characteristics and random biopsy detection rates were similar among the groups. Magnetic resonance imaging detected at least 1 suspicious area in 54 (42%), 78 (59%) and 82 patients (62%) in groups 1, 2 and 3, respectively. The cancer detection rates of rigid and elastic system targeted biopsies were significantly higher than the random biopsy rate (p = 0.0065 and 0.0016, respectively). Visual targeted biopsy did not perform better than random biopsy (p = 0.66). Rigid and elastic system targeted biopsies allowed for decreasing the number of cores and the detection of microfocal cancer, while increasing the detection of high grade cancer. CONCLUSIONS: When performed with computerized magnetic resonance imaging-transrectal ultrasound image registration, targeted biopsy alone improved cancer detection over random biopsies, decreased the detection rate of microfocal cancer and increased the detection rate of cancer with a Gleason score of greater than 6.