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MR-Guided Cryoablation of Prostate Bed Recurrences

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Disease Attributes
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Pathologic Processes
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014