MR-Guided Cryoablation of Prostate Bed Recurrences
Not Applicable
Recruiting
- Conditions
- Prostate Tumors
- Interventions
- Procedure: MR-guided cryoablation
- Registration Number
- NCT01727284
- Lead Sponsor
- Mayo Clinic
- Brief Summary
The purpose of this research is to see if MR-guided cryoablation can effectively treat prostate tumor recurrences.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 200
Inclusion Criteria
- Patients with "biopsy proven" soft tissue tumor recurrences of prostate fossa
- Surgery is not a desirable alternative therapy at the time of enrollment
- Radiation therapy has failed or not indicated or can be safely postponed
- Tumor size is < 5 cm at its largest diameter
- Tumor does not encompass the rectal wall or external urethral sphincter
- Patient is able to undergo MRI
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Exclusion Criteria
- N/A
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MR-guided cryoablation (freezing of tissue and/or tumors) MR-guided cryoablation Patients undergo cryoablation using the Galil MR-compatible cryoablation system and MRI while on study.
- Primary Outcome Measures
Name Time Method Evaluation of target lesion at 3-6, 12, 24, and 36 month imaging follow-up 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States