Back to resultsMR-Guided Cryoablation of Prostate Bed Recurrences
Primary Purpose
Prostate Tumors
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MR-guided cryoablation
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
- 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 is < 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 in RochesterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MR-guided cryoablation (freezing of tissue and/or tumors)
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of target lesion at 3-6, 12, 24, and 36 month imaging follow-up
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01727284
Brief Title
MR-Guided Cryoablation of Prostate Bed Recurrences
Official Title
Technical Success, Safety, and Short and Long-term Efficacy for MR-Guided Cryoablation of Prostate Bed Recurrences
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2012 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
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 research is to see if MR-guided cryoablation 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
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MR-guided cryoablation (freezing of tissue and/or tumors)
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
MR-guided cryoablation
Primary Outcome Measure Information:
Title
Evaluation of target lesion at 3-6, 12, 24, and 36 month imaging follow-up
Time Frame
3 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with "biopsy proven" soft tissue tumor recurrences of prostate fossa
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 is < 5 cm at its largest diameter
Tumor does not encompass the rectal wall or external urethral sphincter
Patient is able to undergo MRI
Exclusion Criteria:
N/A
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Murphy
Phone
507-538-0540
Email
Murphy.Jennifer@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Desirae Howe-Clayton
Phone
507-255-0111
Email
Howe.Desirae@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Woodrum, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Murphy
Phone
507-538-0540
Email
Murphy.Jennifer@mayo.edu
First Name & Middle Initial & Last Name & Degree
David A Woodrum, M.D., Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
MR-Guided Cryoablation of Prostate Bed Recurrences
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