MRI-Guided Cryoablation for Focal Native Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MR guided cryoablation.
- Who it may be relevant to
- Registry conditions: Primary Malignant Neoplasm of Prostate (Diagnosis). Basic parameters: 30 years — 100 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure MR guided cryoablation
MR guided cryoablation of focal biopsy proven prostate cancer
Primary outcome measures
- Technical success of the MR-guided cryoablation [Time frame: Will assess for 5 years with interval assessment each year]
- Safety of the MR-guided cryoablation [Time frame: Will assess for 5 years with interval assessment each year]
- Examine short term tumor recurrence [Time frame: Will assess for 5 years with interval assessment each year]
Secondary outcome measures (1)
- MR procedure time. [Time frame: Will assess for 5 years with interval assessment each year]
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
•
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT04797039 · 20-003822