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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

Tracking Information
First Submitted Date  ICMJE November 12, 2012
First Posted Date  ICMJE November 15, 2012
Last Update Posted Date January 10, 2023
Actual Study Start Date  ICMJE December 12, 2012
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2014)		 Evaluation of target lesion at 3-6, 12, 24, and 36 month imaging follow-up [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 14, 2012)
  • Determine the technical success of MR-guided cryoablation as measured by complete target lesion ablation. [ Time Frame: 3-6 months ]
  • Determine safety of MR-guided cryoablation using continuous MR imaging during procedure [ Time Frame: Procedure, 3-6 months ]
  • Examine short-term tumor recurrence over 6 months with contrast enhanced MRI [ Time Frame: 3-6 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MR-Guided Cryoablation of Prostate Bed Recurrences
Official Title  ICMJE Technical Success, Safety, and Short and Long-term Efficacy for MR-Guided Cryoablation of Prostate Bed Recurrences
Brief Summary The purpose of this research is to see if MR-guided cryoablation can effectively treat prostate tumor recurrences.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Tumors
Intervention  ICMJE Procedure: MR-guided cryoablation
Study Arms  ICMJE MR-guided cryoablation (freezing of tissue and/or tumors)
Intervention: Procedure: MR-guided cryoablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 14, 2012)		 100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer Murphy 507-538-0540 Murphy.Jennifer@mayo.edu
Contact: Desirae Howe-Clayton 507-255-0111 Howe.Desirae@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01727284
Other Study ID Numbers  ICMJE 12-002245
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party David A. Woodrum, Mayo Clinic
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mayo Clinic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Woodrum, MD, PhD Mayo Clinic
PRS Account Mayo Clinic
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP