MRI-Guided Cryoablation for Focal Native Prostate Cancer
Conditions
Primary Malignant Neoplasm of Prostate (Diagnosis)Summary
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.
Detailed Description
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.
Locations
1 location Found with status Recruiting
Eligibility Criteria
Inclusion Criteria:
* Patients with "biopsy proven" Gleason7 prostate cancer referred to Urology and/or Interventional Radiology for treatment
* Surgery and/or Radiation is not a desirable alternative therapy at the time of enrollment
* Tumor size is < 2 cm at its largest diameter
* Tumor does not encompass the rectal wall or external urethral sphincter
* Patient is able to undergo MRI
Exclusion Criteria:
•
Study Plan
MR guided cryoablation
Focal MR guided cryoablation for low- to intermediate-grade prostate cancer
PROCEDURE:
MR guided cryoablationDescription:
MR guided cryoablation of focal biopsy proven prostate cancer
Outcome Measures
Primary Outcome Measures
Technical success of the MR-guided cryoablation
Safety of the MR-guided cryoablation
Examine short term tumor recurrence
Secondary Outcome Measures
MR procedure time.
Timeline
Last Updated
April 16, 2024Start Date
March 15, 2021Today
February 5, 2025Completion Date ( Estimated )
December 1, 2030
Sponsors of this trial
Lead Sponsor
Mayo Clinic