A Pilot Study to Evaluate Magnetic Resonance Thermal Image-Guided Focal Laser Ablation of Prostate Cancer Tumors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Mayo Clinic
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Incidence of treatment emergent adverse events
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
The primary purpose of this study is to evaluate the feasibility and safety of MRI-guided focal laser ablation (Laser-Induced Interstitial Thermal Therapy, LITT) to treat low-risk native prostate cancer.
Detailed Description
The study is being done to evaluate the safety and effectiveness of Magnetic Resonance Imaging (MRI)-guided focal laser therapy with the Visualase Thermal Therapy System to treat low-risk prostate cancer tumors. Unlike surgery or radiotherapy which affects a large portion of the prostate or the entire organ, localized or focal therapy is intended to treat a small portion of tissue in which the cancer has been found by biopsy.
Investigators
David A. Woodrum
David A. Woodrum, M.D., Ph.D.
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of treatment emergent adverse events
Time Frame: 3 years
To evaluate patient-related safety by monitoring short and long-term complications related to the procedure such as but not limited to incontinence, impotence, and urethral fistulas.
Success rate
Time Frame: 3 years
To evaluate the procedural success rate of using the MR-guided laser ablation to target, access, thermally monitor, and focally ablate MR-visible prostate cancer lesions.
Secondary Outcomes
- Short- and mid-term ablative success(3 years)