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MR-Guided Cryoablation of Prostate Bed Recurrences

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ClinicalTrials.gov Identifier: NCT01727284
Recruitment Status : Recruiting
First Posted : November 15, 2012
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
David A. Woodrum, Mayo Clinic

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : November 2012
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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


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Ages Eligible for Study:   30 Years to 100 Years   (Adult, Senior)
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

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


Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Connie L. Sathre    507-538-0540    sathre@mayo.edu   
Principal Investigator: David A Woodrum, M.D., Ph.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: David Woodrum, MD, PhD Mayo Clinic

Responsible Party: David A. Woodrum, Assistant Professor of Radiology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01727284     History of Changes
Other Study ID Numbers: 12-002245
First Posted: November 15, 2012    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Recurrence
Prostatic Neoplasms
Disease Attributes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases