This clinical trial is to provide a minimally invasive treatment option in which the targeted prostate cancer tissue is killed by microwave only in the specific area of cancer "that should be treated for saving of life," while leaving a portion of the normal prostate tissue that is not cancerous. This treatment is named "focal therapy" for "clinically localized prostate cancer." As this new treatment aims to treat only the specific prostatic area of cancer, it is different from the invasive conventional treatment to remove the entire prostate gland. The goal is both to control the known cancer by treating only the cancerous area and to maintain the quality of life (QOL) by leaving the other normal prostate tissue and its surrounding organs intact, resulting in the prevention of urinary leakage and sexual dysfunction as complications.
This trial will provide ultrasound-guided targeted microwave tissue coagulation of known cancer lesions in patients diagnosed with clinically localized prostate cancer, and it will assess efficacy and safety endpoints for up to six months post-operatively. This trial will also assess patient quality of life (QOL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Targeted Microwave Tissue Coagulation
Kyoto Prefectural University of Medicine
Kyoto, Japan
RECRUITINGProportion of participants achieving disappearance of cancer
Disappearance of cancer is defined with the following criteria: 1. A 50% or greater reduction from the preoperative serum PSA level. 2. A reduction of PI-RADS category of the targeted prostate cancer lesion down to 3 or lower (including 'difficult to judge' and 'change after treatment') on MRI images. 3. No cancer tissue in histopathological examination from the targeted prostate cancer lesion via a needle biopsy.
Time frame: 6 months
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