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

JRCT ID: jRCTs052240015

Registered date:01/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Localized Prostate Cancer
• Date of first enrollment: 01/05/2024
• Target sample size: 65
• Study type: Interventional
• Intervention(s): Percutaneously Prostate Cancer Lesion Targeted Microwave Tissue Coagulation

Outcome(s)

Primary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Male

Include 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

Exclude 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

Related Information

• Primary Sponsor: Ukimura Osamu