MR-Guided Cryoablation of Prostate Bed Recurrences

This study is currently recruiting participants.
Verified April 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
David A. Woodrum, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01727284
First received: November 12, 2012
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Prostate Tumors
Procedure: MR-guided cryoablation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Technical Success, Safety, and Short and Long-term Efficacy for MR-Guided Cryoablation of Prostate Bed Recurrences

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Evaluation of target lesion at 3-6, 12, 24, and 36 month imaging follow-up [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MR-guided cryoablation (freezing of tissue and/or tumors) Procedure: MR-guided cryoablation

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: David A. Woodrum, Assistant Professor of Radiology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01727284     History of Changes
Other Study ID Numbers: 12-002245
Study First Received: November 12, 2012
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014