Microwave Intervention Under Local Anesthesia

This clinical investigation is a prospective feasibility study designed to evaluate the feasibility of performing a focal Targeted Microwave Ablation (TMA) procedure using Koelis TMA® under local anesthesia in patient with localized prostate cancer. Koelis TMA® is a CE-marked medical device use without any modification to the device's intended use.

The study will be conducted in a routine clinical care setting. Eligible patients requiring the procedure will be included after providing informed consent.

The study consists of four visits. At the inclusion visit (Visit 0), patient eligibility will be confirmed and baseline data will be collected. The intervention will be performed during Visit 1 under local anesthesia according to standard clinical practice. A follow-up phone call (Visit 2) will be conducted 7 days after the procedure (±2 days) to assess safety and tolerability data. The end-of-study visit (Visit 3) will take place 1 month after the intervention (±7 days) during a routine follow-up consultation.

The primary objective of the study is to assess the feasibility of performing the procedure under local anesthesia. Feasibility will be evaluated by the proportion of patients in whom the procedure is successfully completed under local anesthesia. If the patient presents marked discomfort, pain, or any other symptoms that make the continuation of the procedure inappropriate, it may be interrupted at his request or at the initiative of the investigator. Local anesthesia can therefore be converted to general anesthesia or deep sedation to allow treatment to continue.

Secondary objectives include the assessment of procedure tolerability, safety, ease of performance as assessed by the operator, patient satisfaction related to anesthesia, and the amount of analgesic or pain medication administered during the study period.