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MR-Guided Cryoablation of Prostate Bed Recurrences

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01727284
Recruitment Status : Recruiting
First Posted : November 15, 2012
Last Update Posted : January 10, 2023
Sponsor:
Information provided by (Responsible Party):
David A. Woodrum, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Prostate Tumors Procedure: MR-guided cryoablation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Technical Success, Safety, and Short and Long-term Efficacy for MR-Guided Cryoablation of Prostate Bed Recurrences
Actual Study Start Date : December 12, 2012
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
MR-guided cryoablation (freezing of tissue and/or tumors) Procedure: MR-guided cryoablation


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of target lesion at 3-6, 12, 24, and 36 month imaging follow-up [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727284


Contacts
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Contact: Jennifer Murphy 507-538-0540 Murphy.Jennifer@mayo.edu
Contact: Desirae Howe-Clayton 507-255-0111 Howe.Desirae@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jennifer Murphy    507-538-0540    Murphy.Jennifer@mayo.edu   
Principal Investigator: David A Woodrum, M.D., Ph.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: David Woodrum, MD, PhD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: David A. Woodrum, Assistant Professor of Radiology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01727284    
Other Study ID Numbers: 12-002245
First Posted: November 15, 2012    Key Record Dates
Last Update Posted: January 10, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes