Prostate Cancer Lesion Targeted Cryoablation: Investigator Initiated Trial

JRCT ID: jRCT2052210088

Registered date:22/09/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prostate Cancer
• Date of first enrollment: 19/10/2021
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Cancer lesion-targeted cryotherapy for localized prostate cancer

Outcome(s)

Primary Outcome

Achievement of 1), 2), and 3) 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 PI-RADS category 3 or 4 lesion on MRI image at enrollment and who have a single lesion with a Gleason score 7 or 8 on histopathology of the prostate needle biopsy at enrollment; or, patients who have a PI-RADS category 4 or 5 lesion on MRI image at enrollment and who have a single lesion with 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 who have a single lesion with 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 an external urinary sphincter is 5 mm or less on MRI images (coronal or sagittal) obtained during enrollment
6) Patients who have undergone surgery, drug therapy, or radiation therapy for prostate cancer prior to enrollment
7) Patients who have received an antiandrogen for benign prostatic hyperplasia prior to enrollment
8) Patients using absorbent pads or adult diapers due to urge incontinence
9) Patients with active multiple cancers
10) Patients for whom MRI scans are contraindicated
11) Patients in whom transrectal ultrasound cannot be performed for some reason, such as a constricted rectum
12) Patients with a prothrombin time<50% or platelet count<60,000/mm3 during enrollment
13) Patients deemed to be ineligible by an investigator

Related Information

• Primary Sponsor: Ukimura Osamu
• Secondary Sponsor: Ukimura Osamu,Japan Agency for Medical Research and Development (AMED)
• Secondary ID(s): NCT05500846