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MR-Guided Laser Ablation of Prostate Bed Recurrences

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01743638
First Posted: December 6, 2012
Last Update Posted: April 10, 2014
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.
Information provided by (Responsible Party):
David A. Woodrum, Mayo Clinic
  Purpose
The purpose of this study is to see if MR-guided laser ablation can effectively treat prostate tumor recurrences.

Condition Intervention
Prostate Tumors Procedure: MR-Guided Laser Ablation

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by David A. Woodrum, Mayo Clinic:

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

Enrollment: 0
Study Start Date: April 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MR-Guided Laser Ablation Procedure: MR-Guided Laser Ablation

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 95 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 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
  Contacts and Locations
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): NCT01743638


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: David A. Woodrum, M.D., Ph.D. Mayo Clinic
  More Information

Responsible Party: David A. Woodrum, Assistant Professor of Radiology, Mayo Clinic, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01743638     History of Changes
Other Study ID Numbers: 09-001584
First Submitted: December 4, 2012
First Posted: December 6, 2012
Last Update Posted: April 10, 2014
Last Verified: April 2014

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