The purpose of this research is to collect data about the MRI cryoablation procedure your doctor(s) would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after the participants treatment is performed. Participants have been asked to take part in this research because the participants have been diagnosed with prostate cancer and scheduled to have an ablation procedure.
The purpose of this study is to evaluate MR-guided cryoablation of biopsy proven prostate tumors using the Galil MRI-compatible cryoablation system. The system has been approved by the United States Food and Drug Administration (FDA) for soft tissue ablation and has been utilized successfully at Mayo. All procedures will be performed according to approved indications. the investigators wish to monitor the technique and collect data at the participants follow-up visits. The study only collects data about the MRI-guided cryoablation procedure the participants doctor(s) would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after there treatment is performed. The participants doctor will advise the participants when the participants should return for follow-up visits. These visits will be according to the participants doctor's standard of care; usually return visits are at 3-6months, 12 months, 24 months, 36 months, 48 months and 60 months after the procedure, although the participants doctor may ask that the participants return for more frequent visits.
Study Type
OBSERVATIONAL
Enrollment
100
MR guided cryoablation of focal biopsy proven prostate cancer
Mayo Clinic
Rochester, Minnesota, United States
RECRUITINGTechnical success of the MR-guided cryoablation
Determine the technical success of the MR-guided cryoablation as measured by complete target lesion ablation.
Time frame: Will assess for 5 years with interval assessment each year
Safety of the MR-guided cryoablation
Determine safety of the MR-guided cryoablation using continuous MR imaging during the procedure.
Time frame: Will assess for 5 years with interval assessment each year
Examine short term tumor recurrence
Examine short term tumor recurrence over 6 months with contrast enhanced MRI and as required MR or U/S guided biopsy of prostate bed if PSA biochemical recurrence.
Time frame: Will assess for 5 years with interval assessment each year
MR procedure time.
We will examine the time for each step in the process to create a stream-lined process and minimize MR procedure time.
Time frame: Will assess for 5 years with interval assessment each year
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