## Protocol Section
### Identification Module
**NCT ID:** NCT06430749

**Acronym:** MicroPro2

**Brief Title:** Targeted Microwave Tissue Coagulation for Prostate Cancer

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

#### Organization Study ID Info
**ID:** CTREC-S220202
#### Organization
**Class:** OTHER
**Full Name:** Kyoto Prefectural University of Medicine
#### Secondary ID Infos
**Domain:** Japan Registry of Clincal Trials
**ID:** jRCTs052240015
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-10-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-10-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Osamu Ukimura

#### Responsible Party

**Investigator Affiliation:** Kyoto Prefectural University of Medicine

**Investigator Full Name:** Osamu Ukimura

**Investigator Title:** Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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. It is a treatment, named by "focal therapy" for "clinically localized prostate cancer". As this new treatment is aiming to treat only specific prostatic area of cancer, it is different from the invasive conventional treatment to remove the entire prostate gland. The goal is to achieve both to control of known cancer by treating only the cancerous area and to maintain of QOL (Quality-of-life) by leaving of the other normal prostate tissue and its surrounding organs intact resulting in prevention of urinary-leakage and sexual-dysfunction as the complications.

**Detailed Description:** This trial will to provide an ultrasound-guided targeted microwave tissue coagulation of known cancer lesions in patients diagnosed with clinically localized prostate cancer, and this trial will assess efficacy and safety endpoints for up to post-operative 6 months. This trial will assess patient quality of life (QOL) as well.

### Conditions Module

**Conditions:**

- Prostate Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Single Group Assignment

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 65

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The Minimally invasive microwave coagulation surgery will be performed under general anesthesia for aiming to be provided total 65 patients.

**Intervention Names:**

- Device: Microtaze

**Label:** Microwave Tissue Coagulation Arm

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Microwave Tissue Coagulation Arm

**Description:** Targeted Microwave Tissue Coagultion

**Name:** Microtaze

**Other Names:**

- AFM-712

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Achievement of 1) serum marker, 2) imaging, and 3) histopathological examination, below

1. A 50% or greater reduction from the preoperative serum PSA level at postoperative 3 or 6 months
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') at MRI images at postoperative 6 months
3. No cancer tissue in histopathological examination from the targeted prostate cancer lesion via a needle biopsy of the prostate performed at postoperative 6 months

**Measure:** Disappearance of cancer at 6 month after microwave coagulation evaluated by combination of the responses in PSA, MRI, and Prostate biopsy

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. 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
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 this trial
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 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)
2. 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)
3. 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')
4. Patients with a serum prostate-specific antigen (PSA) level over 20 ng/ml during enrollment
5. 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
6. Patients who have received an antiandrogen for benign prostatic hyperplasia prior to enrollment
7. Patients who have received an antiandrogen for benign prostatic hyperplasia prior to enrollment
8. Patients who have undergone surgery, drug therapy, or radiation therapy for prostate cancer 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 as a 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

**Maximum Age:** 85 Years

**Minimum Age:** 20 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ukimura@koto.kpu-m.ac.jp

**Name:** Osamu Ukimura, Professor

**Phone:** +81 75 251 5595

**Role:** CONTACT

**Contact 2:**

**Email:** micropro@koto.kpu-m.ac.jp

**Name:** Toshiko Ito-Ihara, M.D.

**Phone:** +81 75 251 5308

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Kyoto

**Contacts:**

***Contact 1:***

- **Email:** micropro@koto.kpu-m.ac.jp

- **Name:** Osamu Ukimura, M.D., Ph.D.

- **Phone:** +81 75 251 5595

- **Role:** CONTACT

***Contact 2:***

- **Email:** micropro@koto.kpu-m.ac.jp

- **Name:** Toshiko Ito-Ihara, M.D., Ph.D.

- **Phone:** +81 75 251 5308

- **Role:** CONTACT

**Country:** Japan

**Facility:** Kyoto Prefectural University of Medicine

**Status:** RECRUITING

**Zip:** 602-8566

#### Overall Officials

**Official 1:**

**Affiliation:** Kyoto Prefectural University of Medicine

**Name:** Osamu Ukimura, Professor

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005834

- Term: Genital Neoplasms, Male

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: HIGH

- As Found: Prostate Cancer

- ID: M8946

- Name: Genital Neoplasms, Male

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011471

- Term: Prostatic Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
