Technical Success, Safety, and Short and Long-term Efficacy for MR-Guided Cryoablation of Prostate Bed Recurrences

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Technical Success, Safety, and Short and Long-term Efficacy for MR-Guided Cryoablation of Prostate Bed Recurrences

Condition: Prostate Tumors

Intervention:

  • Procedure: MR-guided cryoablation

Purpose: The purpose of this research is to see if MR-guided cryoablation can effectively treat prostate tumor recurrences.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01727284

Sponsor: Mayo Clinic

Primary Outcome Measures:

  • Measure: Evaluation of target lesion at 3-6, 12, 24, and 36 month imaging follow-up
  • Time Frame: 3 years
  • Safety Issue:

Estimated Enrollment: 100

Study Start Date: December 12, 2012

Eligibility:

  • Age: minimum 30 Years maximum 100 Years
  • Gender: Male

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
  • Performance status is ECOG 2 or better in adults
  • Patient is able to undergo MRI

Exclusion Criteria:

  • Patients with pacemaker or defibrillator

Location:

  • Mayo Clinic in Rochester
  • Rochester Minnesota 55905 United States

View trial on ClinicalTrials.gov

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