MR-Guided Laser Ablation of Prostate Bed Recurrences

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
David A. Woodrum, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01743638
First received: December 4, 2012
Last updated: April 9, 2014
Last verified: April 2014
  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:


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 ]

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

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
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: 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

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: April 9, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 15, 2014