Targeted Microwave Tissue Coagulation for Prostate Cancer

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

20 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who have a single lesion of PI-RADS category 3 or 4 lesion on MRI image at enrollment and which is proved as a Gleason score 7 or 8 on histopathology of the prostate needle biopsy at enrollment; or, patients who have a single lesion of PI-RADS category 4 or 5 lesion on MRI image at enrollment and which is proved as a Gleason score 6 or 7 on histopathology of the prostate needle biopsy at enrollment
Patients with prostate cancer that is clinical stage T2c or lower (T1a-T2cN0M0) according to the TNM Classification as determined during enrollment
Patients between the ages of 20 and 85 when providing consent to participate in this trial
Patients from whom consent is obtained prior to enrollment in this trial

Exclusion criteria

Patients to have a lesion identified as PI-RADS category 4 or 5 on MRI images at enrollment and which is a diameter of less than 10 mm and Gleason score of 6 on the histopathology of the prostate needle biopsy at enrollment (the lesion is referred to as 'non-target lesions') (the diameter of the lesion is defined as the longer one of the lesion diameter identified on MRI images at enrollment or the tumor length as measured on histopathology of prostate needle biopsy)
Patients to have 4 or more non-target lesions (non-target lesions are defined as the lesions defined in exclusion criterion 1, or lesions with PI-RADS category 3 on MRI image at enrollment and Gleason score 6 on biopsy at enrollment)
Patients to have a lesion with PI-RADS category 5 on MRI image at enrollment and Gleason score 8 on histopathology of prostate needle biopsy at enrollment (the lesion is referred 'excluded lesions')
Patients with a serum prostate-specific antigen (PSA) level over 20 ng/ml during enrollment
Patients in whom the distance from the target prostate cancer lesion to the rectum is 10 mm or less on MRI images (coronal or sagittal) obtained during enrollment
Patients who have received an antiandrogen for benign prostatic hyperplasia prior to enrollment
Patients who have received an antiandrogen for benign prostatic hyperplasia prior to enrollment
Patients who have undergone surgery, drug therapy, or radiation therapy for prostate cancer prior to enrollment
Patients with active multiple cancers
Patient who wear a pacemaker
Patients for whom MRI scans are contraindicated
Patients in whom transrectal ultrasound cannot be performed for some reason, such as a constricted rectum
Patients with a prothrombin time<50% or platelet count<60,000/mm3 during enrollment
Patients deemed to be ineligible by an investigator

Treatment and study plan

Microtaze

Device

Targeted Microwave Tissue Coagulation

Other names: AFM-712

Primary outcomes

Proportion of participants achieving disappearance of cancer

Time frame: 6 months
Disappearance of cancer is defined with the following criteria:
- A 50% or greater reduction from the preoperative serum PSA level.
- 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.
- No cancer tissue in histopathological examination from the targeted prostate cancer lesion via a needle biopsy.

Sponsors and collaborators

Lead sponsor

Osamu Ukimura

Other

Registry information

Official study title

Clinical Trial of Evaluating Efficacy and Safety for Percutaneously Prostate Cancer Lesion Targeted Microwave Tissue Coagulation as Prostate Functional Preservation

Acronym: MicroPro2

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: May 28, 2024
Registry last updated: Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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