Back to resultsMR-Guided Laser Ablation of Prostate Bed Recurrences
Primary Purpose
Prostate Tumors
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MR-Guided Laser Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Tumors
Eligibility 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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MR-Guided Laser Ablation
Arm Description
Outcomes
Primary Outcome Measures
Measurement of target lesion(s) dimensions at 3-6 month imaging follow-up
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01743638
Brief Title
MR-Guided Laser Ablation of Prostate Bed Recurrences
Official Title
Technical Success, Safety, and Short-term Efficacy for MR-Guided Laser Ablation of Prostate Bed Recurrences
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Withdrawn
Study Start Date
April 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to see if MR-guided laser ablation can effectively treat prostate tumor recurrences.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MR-Guided Laser Ablation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
MR-Guided Laser Ablation
Primary Outcome Measure Information:
Title
Measurement of target lesion(s) dimensions at 3-6 month imaging follow-up
Time Frame
3-6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A. Woodrum, M.D., Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
MR-Guided Laser Ablation of Prostate Bed Recurrences
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