Targeted Microwave Tissue Coagulation for Prostate Cancer

Launched by OSAMU UKIMURA · May 21, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option called targeted microwave tissue coagulation for men with localized prostate cancer. This approach, known as focal therapy, aims to specifically target and destroy only the cancerous tissue in the prostate while preserving the healthy parts of the gland. By doing so, the treatment hopes to control the cancer effectively while minimizing side effects, such as urinary leakage and sexual dysfunction, which can occur with more invasive treatments that remove the entire prostate.

To participate in this trial, men aged 20 to 85 may be eligible if they have a specific type of prostate cancer that meets certain criteria, including having a single cancer lesion shown through an MRI scan and confirmed by a biopsy. Participants can expect to undergo this innovative procedure, which is designed to be less invasive than traditional methods, and will be monitored throughout the trial to assess its effectiveness and safety. It's important for potential participants to discuss their individual health situations with their doctors to determine if they qualify for this study.

Gender

MALE

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