Targeted Microwave Tissue Coagulation for Prostate Cancer

Inclusion Criteria:

1. Patients who have a single lesion of PI-RADS category 3 or 4 lesion on MRI image atenrollment and which is proved as a Gleason score 7 or 8 on histopathology of theprostate needle biopsy at enrollment; or, patients who have a single lesion ofPI-RADS category 4 or 5 lesion on MRI image at enrollment and which is proved as aGleason score 6 or 7 on histopathology of the prostate needle biopsy at enrollment

2. Patients with prostate cancer that is clinical stage T2c or lower (T1a-T2cN0M0)according to the TNM Classification as determined during enrollment

3. Patients between the ages of 20 and 85 when providing consent to participate in thistrial

4. Patients from whom consent is obtained prior to enrollment in this trial

Exclusion Criteria:

1. Patients to have a lesion identified as PI-RADS category 4 or 5 on MRI images atenrollment and which is a diameter of less than 10 mm and Gleason score of 6 on thehistopathology of the prostate needle biopsy at enrollment (the lesion is referredto as 'non-target lesions') (the diameter of the lesion is defined as the longer oneof the lesion diameter identified on MRI images at enrollment or the tumor length asmeasured on histopathology of prostate needle biopsy)

2. Patients to have 4 or more non-target lesions (non-target lesions are defined as thelesions defined in exclusion criterion 1, or lesions with PI-RADS category 3 on MRIimage at enrollment and Gleason score 6 on biopsy at enrollment)

3. Patients to have a lesion with PI-RADS category 5 on MRI image at enrollment andGleason score 8 on histopathology of prostate needle biopsy at enrollment (thelesion is referred 'excluded lesions')

4. Patients with a serum prostate-specific antigen (PSA) level over 20 ng/ml duringenrollment

5. Patients in whom the distance from the target prostate cancer lesion to the rectumis 10 mm or less on MRI images (coronal or sagittal) obtained during enrollment

6. Patients who have received an antiandrogen for benign prostatic hyperplasia prior toenrollment

7. Patients who have received an antiandrogen for benign prostatic hyperplasia prior toenrollment

8. Patients who have undergone surgery, drug therapy, or radiation therapy for prostatecancer prior to enrollment

9. Patients with active multiple cancers

10. Patient who wear a pacemaker

11. Patients for whom MRI scans are contraindicated

12. Patients in whom transrectal ultrasound cannot be performed for some reason, such asa constricted rectum

13. Patients with a prothrombin time<50% or platelet count<60,000/mm3 during enrollment

14. Patients deemed to be ineligible by an investigator