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MR-Guided Laser Ablation 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. Read our disclaimer for details. Identifier: NCT01743638
Recruitment Status : Withdrawn
First Posted : December 6, 2012
Last Update Posted : April 10, 2014
Information provided by (Responsible Party):
David A. Woodrum, Mayo Clinic

Brief Summary:
The purpose of this study is to see if MR-guided laser ablation can effectively treat prostate tumor recurrences.

Condition or disease Intervention/treatment Phase
Prostate Tumors Procedure: MR-Guided Laser Ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Technical Success, Safety, and Short-term Efficacy for MR-Guided Laser Ablation of Prostate Bed Recurrences
Study Start Date : April 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: MR-Guided Laser Ablation Procedure: MR-Guided Laser Ablation

Primary Outcome Measures :
  1. Measurement of target lesion(s) dimensions at 3-6 month imaging follow-up [ Time Frame: 3-6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with "biopsy proven" soft tissue tumor recurrences of prostate fossa referred to Urology and/or Interventional Radiology for treatment.
  • 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 ≤ 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 identifier (NCT number): NCT01743638

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: David A. Woodrum, M.D., Ph.D. Mayo Clinic
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Responsible Party: David A. Woodrum, Assistant Professor of Radiology, Mayo Clinic, Mayo Clinic Identifier: NCT01743638    
Other Study ID Numbers: 09-001584
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes