Efficacy Assessment of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer

Inclusion Criteria:

• Patient aged from 45 to 76 years old
• Life expectancy >10 years at the inclusion time
• Patient diagnosed with an intermediate-risk prostate cancer, defined by:
• A T1c or T2a clinical stage
• A unique cancer focus of Gleason (3+4) (Grade Group 2)
• A PSA level <20 ng/mL
• Cancer focus identified on a multiparametric MRI of the prostate no more than 3 monthsbefore inclusion
• Confirmation of the suspicion of cancer identified on the MRI with transrectal ortransperineal targeted and systematic biopsies performed with the KOELIS TRINITYsystem (no more than 3 months before inclusion)
• Patient suitable for IV sedation or general anesthesia and focal microwave ablation
• No debilitating medical or psychiatric illness that would preclude giving informedconsent or receiving optimal treatment and follow-up
• Known coagulopathy or bleeding disorders are controlled
• Free, informed and written consent, dated and signed before the enrollment and beforeany exam required by the trial
• Patient affiliated to social security regimen or beneficiary of such regimen for localregions

Exclusion Criteria:

• Past medical history of prostate surgery
• Past medical history of radiotherapy or pelvic trauma
• Past medical history of acute prostatitis
• Presently taking hormonal manipulation or androgen supplements.
• Past medical history of cancer in the 5 previous years, excluding a non-metastaticbasal cell carcinoma of the skin
• Severe BPH-related urinary tract symptoms, defined by an IPSS score >18
• Serious medical illness, including any of the following: uncontrolled congestive heartfailure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6months prior to the screening visit
• Contraindications for MRI exam
• Extracapsular cancer extension or seminal vesicles or pelvic lymph node invasionsuspected on prostate MRI
• Presence of two or more clinically significant cancer foci in the inclusion biopsyexam
• Presence of a clinically significant cancer with a Gleason score ≥8 (Grade Group ≥4)
• Tumor largest axis >12 mm on the prostate MRI
• Distance between the cancer focus and the apex <10 mm on the prostate MRI
• Distance between the cancer focus and the rectum <5 mm on the prostate MRI
• Patient already participating in an interventional clinical trial
• Patient protected by law