Prostate Cancer Lesion Targeted Cryoablation: Investigator Initiated Trial - PROCRY

kimura Osamu0 sites50 target enrollmentSeptember 22, 2021

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: kimura Osamu
Enrollment: 50
Status: Active, Not Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 22, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

Male

Investigators

Sponsor

kimura Osamu

Eligibility Criteria

Inclusion 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

Exclusion 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