Prostate CancerMicroPro2NCT06430749
Targeted Microwave Tissue Coagulation for Prostate Cancer
A study testing Microtaze in people with Prostate Cancer, run by Osamu Ukimura at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Microtaze
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteJapan
- Study dates
- 1 May 2024to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial of Evaluating Efficacy and Safety for Percutaneously Prostate Cancer Lesion Targeted Microwave Tissue Coagulation as Prostate Functional Preservation
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.
Read the detailed description
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).
- Conditions
- Prostate Cancer
- Being tested
- Microtaze
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrotazeDevice
Also called AFM-712
Targeted Microwave Tissue Coagulation
| Study group | Role | What they receive |
|---|---|---|
| Microwave Tissue Coagulation Arm | Experimental | The Minimally invasive microwave coagulation surgery will be performed under general anesthesia for aiming to be provided total 65 patients. Receives: Device: Microtaze |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving disappearance of cancer
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 May 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osamu Ukimura
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Osamu Ukimura, Kyoto Prefectural University of Medicine
- Investigators
- Osamu Ukimura, Professor, Principal investigator, Kyoto Prefectural University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430749
- Sponsor's protocol ID
- CTREC-S220202
- Other IDs
- jRCTs052240015
- Acronym
- MicroPro2
- Status last verified
- Jun 2026
- First submitted
- 21 May 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Evaluating Efficacy and Safety for Percutaneously Prostate Cancer Lesion Targeted Microwave Tissue Coagulation as Prostate Functional Preservation
- ClinicalTrials.gov ID
- NCT06430749
- Acronym / sponsor ID
- MicroPro2 / CTREC-S220202
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Osamu UkimuraUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Microwave Tissue Coagulation Arm | Experimental | Device: MicrotazeThe Minimally invasive microwave coagulation surgery will be performed under general anesthesia for aiming to be provided total 65 patients. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicrotazeAlso: AFM-712Targeted Microwave Tissue Coagulation | Device | Microwave Tissue Coagulation Arm |
Primary outcome
Proportion of participants achieving disappearance of cancer
Time frame: 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osamu Ukimura, Professor principal investigator
Kyoto Prefectural University of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microtaze in people with Prostate Cancer, run by Osamu Ukimura at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving disappearance of cancer (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026; AzTrials last refreshed its copy on 5 Nov 2026.