Localized Prostate Carcinoma, Prostate Adenocarcinoma, Prostate Cancer, Stage II Prostate Cancer AJCC v8, Stage I Prostate Cancer AJCC v8
Conditions
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.
Interventions
PROCEDUREFocal laser ablation of the prostate
MR guided laser ablation of the focal prostatic lesion which has been identified by MRI and biopsy prior to ablation.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate | 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. |
| Incidence of treatment emergent adverse events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short- and mid-term ablative success | 3 years | To obtain preliminary data on ablative success using longitudinal MR imaging assessment of treated areas. |
Countries
United States
Outcome results
None listed