Description:
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.
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.
Recruiting
N/A
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.
Name | Type | Description | Interventions |
---|---|---|---|
Single arm study | Experimental | MR guided focal laser ablation of prostate cancer using the Visualase Thermal Therapy System. |
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 45 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Measure: | Success rate |
Time Frame: | 3 years |
Safety Issue: | |
Description: | 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. |
Measure: | Short- and mid-term ablative success |
Time Frame: | 3 years |
Safety Issue: | |
Description: | To obtain preliminary data on ablative success using longitudinal MR imaging assessment of treated areas. |
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Mayo Clinic |
April 27, 2021