Technical Success, Safety, and Short-term Efficacy for MR-Guided Laser Ablation of Prostate Bed Recurrences
N/A
50 Years
95 Years
50 Years
95 Years
Open (Enrolling)
Male
Prostate Tumors
Male
Prostate Tumors
Trial Information
Technical Success, Safety, and Short-term Efficacy for MR-Guided Laser Ablation of Prostate Bed Recurrences
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Measurement of target lesion(s) dimensions at 3-6 month imaging follow-up
Outcome Time Frame:
3-6 months
Safety Issue:
Yes
Principal Investigator
David A. Woodrum, M.D., Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Institutional Review Board
Study ID:
09-001584
NCT ID:
NCT01743638
Start Date:
April 2012
Completion Date:
April 2016
Related Keywords:
- Prostate Tumors
- Prostatic Neoplasms
- Recurrence
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
