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MR-Guided Laser Ablation of Prostate Bed Recurrences

This study is currently recruiting participants.
Verified December 2012 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
David A. Woodrum, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01743638
First received: December 4, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

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

Estimated Enrollment: 19
Study Start Date: April 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MR-Guided Laser Ablation Procedure: MR-Guided Laser Ablation

  Eligibility

Ages Eligible for Study:   50 Years to 95 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743638

Locations
United States, Minnesota
Mayo Clinic 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 A. Woodrum, M.D., Ph.D. Mayo Clinic
  More Information

No publications provided

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
Study First Received: December 4, 2012
Last Updated: December 4, 2012
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 May 19, 2013