- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02600156
Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors
December 22, 2023 updated by: David A. Woodrum, Mayo Clinic
A Pilot Study to Evaluate Magnetic Resonance Thermal Image-Guided Focal Laser Ablation of Prostate Cancer Tumors
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Deb Berg
- Phone Number: 507-255-8454
- Email: RSTInterventionalOncology@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Minnesota
-
Principal Investigator:
- David A. Woodrum, M.D., Ph.D
-
Contact:
- Deb Berg
- Phone Number: 507-255-8454
- Email: RSTInterventionalOncology@mayo.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria
- Male, 45 years of age or older.
- Diagnosis of prostate adenocarcinoma.
- Clinical stage T1c or T2a.
- Gleason score of 7 (3+4 or 4+3) or Intermediate risk Gleason 6
- PSA less than or equal to 20 ng/mL
- Three or fewer biopsy locations with prostate cancer which correlate with MRI findings.
- No lesion > or = 2cm
- One, two, or three tumor suspicious regions identified on multiparametric MRI
- No definite radiographic indication of extra-capsular extension.
- Estimated survival of 5 years or greater, as determined by treating physician.
- Tolerance for anesthesia/sedation.
- Ability to give informed consent.
Exclusion Criteria
- Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
- History of other primary non-skin malignancy within previous three years.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single arm study
MR guided focal laser ablation of prostate cancer using the Visualase Thermal Therapy System.
|
MR guided laser ablation of the focal prostatic lesion which has been identified by MRI and biopsy prior to ablation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 years
|
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.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short- and mid-term ablative success
Time Frame: 3 years
|
To obtain preliminary data on ablative success using longitudinal MR imaging assessment of treated areas.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Woodrum, MD, PhD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2015
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
September 4, 2015
First Submitted That Met QC Criteria
November 5, 2015
First Posted (Estimated)
November 9, 2015
Study Record Updates
Last Update Posted (Actual)
December 28, 2023
Last Update Submitted That Met QC Criteria
December 22, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-005500
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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