Targeted Microwave Tissue Coagulation for Prostate Cancer

NCT06430749 | Recruiting DMC

• 2 other identifiers: CTREC-S220202jRCTs052240015
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion 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.

  6 months

Study Arms (1)

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.

Device: Microtaze

Interventions

Microtaze DEVICE

Targeted Microwave Tissue Coagulation

Also known as: AFM-712

Microwave Tissue Coagulation Arm

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Osamu Ukimura: lead

Study Sites (1)

Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Osamu Ukimura, Professor

  Kyoto Prefectural University of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Osamu Ukimura, Professor

CONTACT

+81 75 251 5595; micropro@koto.kpu-m.ac.jp

Toshiko Ito-Ihara, M.D.

CONTACT

+81 75 251 5308; micropro@koto.kpu-m.ac.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)