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

Prior treatment

• Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the screening visit

Other illness

• Past medical history of prostate surgery
• Past medical history of radiotherapy or pelvic trauma
• Past medical history of acute prostatitis
• Past medical history of cancer in the 5 previous years, excluding a non-metastatic basal cell carcinoma of the skin
• Extracapsular cancer extension or seminal vesicles or pelvic lymph node invasion suspected on prostate MRI
• Presence of two or more clinically significant cancer foci in the inclusion biopsy exam
• Presence of a clinically significant cancer with a Gleason score ≥8 (Grade Group ≥4)
• Distance between the cancer focus and the apex \<5 mm on the prostate MRI
• Distance between the cancer focus and the rectum \<5 mm on the prostate MRI

Other

• Presently taking hormonal manipulation or androgen supplements.
• Severe BPH-related urinary tract symptoms, defined by an IPSS score \>18
• Contraindications for MRI exam
• Tumor largest axis \>15 mm on the prostate MRI
• Patient already participating in an interventional clinical trial
• Patient protected by law

• Patient aged from 45 to 80 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). In addition to the index lesion intended for treatment, the presence of additional microfoci \< 10mm on mpMRI, for which biopsies present no evidence of cancer or a Gleason score of 3+3, is accepted
  • A PSA level \<20 ng/mL
• Cancer focus identified on a multiparametric MRI of the prostate no more than 3 months before inclusion
• Confirmation of the suspicion of cancer identified on the MRI with transrectal or transperineal targeted and systematic biopsies performed with the KOELIS TRINITY system (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 informed consent 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 before any exam required by the trial
• Patient affiliated to social security regimen or beneficiary of such regimen for local regions