Targeted Cryoablation of Prostate Cancer Lesions: An Investigator-initiated Trial (NCT05500846) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Targeted Cryoablation of Prostate Cancer Lesions: An Investigator-initiated Trial
Japan51 participantsStarted 2021-10-19
Plain-language summary
This clinical trial is to provide a minimally invasive treatment option in which the targeted prostate cancer tissue is killed by cryoablation at extremely low temperatures 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. It is a treatment, named by "focal therapy" for "clinically localized prostate cancer". As this new treatment is aiming to treat only specific prostatic area of cancer, it is different from the invasive conventional treatment to remove the entire prostate gland. The goal is to achieve both to control of known cancer by treating only the cancerous area and to maintain of QOL (Quality-of-life) by leaving of the other normal prostate tissue and its surrounding organs intact resulting in prevention of urinary-leakage and sexual-dysfunction as the complications.
Who can participate
Age range
20 Years – 85 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Disappearance of cancer at 6 month after cryosurgery evaluated by combination of the responses in PSA, MRI, and Prostate biopsy
. 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)
. 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)
. 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 an external urinary sphincter is 5 mm or less on MRI images (coronal or sagittal) obtained during enrollment
. Patients who have undergone surgery, drug therapy, or radiation therapy for prostate cancer prior to enrollment
. Patients who have received an antiandrogen for benign prostatic hyperplasia prior to enrollment
. Patients using absorbent pads or adult diapers due to urge incontinence