Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer

Inclusion Criteria:

* Subjects with initial presentation of organ confined prostate cancer (clinical stage ≤ T2b)

  * Negative metastatic workup with bone scan and CT abdomen/pelvis, within 6 months of study treatment, if indicated by PSA \>10
  * Age 40 years to 85 years of age
  * Multi-parametric MRI at UCLA within 6 months of study treatment, demonstrating a

    * Region of interest (ROI) of MRI suspicion level 3 or higher
    * ROI located proximal to the external sphincter by a margin of at least 2 cm
  * Transrectal ultrasound-guided biopsy with ≥ 10 systematic biopsy cores and ≥ 2 MRI-ultrasound fusion targeted biopsy cores from above MRI-derived ROI

    * Histologically-confirmed adenocarcinoma from targeted biopsy cores (≥ 2 cores)
    * Overall Gleason score not to exceed 3+4
  * Subjects desire focal therapy and declined conventional treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)
  * Signed informed consent for the LITT treatment through the 12 month follow up visit

Exclusion Criteria:

* Any significant cancer outside of MRI target (ROI) area, defined as Gleason score \> 3+4
* \< 10 years life expectancy
* American Society of Anesthesiologists (ASA) criteria of IV or higher
* Unfit for conscious sedation anesthesia
* Active bleeding disorder as determined by abnormal prothrombin time, partial thromboplastin time, INR or platelet count (as determined by institutional lab parameters) at the time of screening
* Use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped for a window of at least 7 days peri-procedure
* Active urinary tract infection
* Prostate abscess, chronic or acute prostatitis, or neurogenic bladder
* Any prior treatment for prostate cancer

  * Radical prostatectomy
  * Radiation therapy (external beam or brachytherapy)
  * Cryotherapy
  * High intensity focused ultrasound treatment
  * Photodynamic therapy
  * Androgen deprivation therapy
* Prior prostate, bladder neck, or urethral stricture surgery

  * Any prostate debulking procedure, including: transurethral resection of prostate, photovaporization, or electrovaporization
  * Transurethral incision of bladder neck
  * Urethral stricture dilation or reconstruction
* Any current 5-alpha reductase inhibitors (history of use ≥ 6 months prior to MRI is acceptable)
* Prior significant rectal surgery (hemorrhoidectomy is acceptable)
* Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device
* History of inflammatory bowel disease
* Urinary tract or rectal fistula
* Any contraindication to MRI (contrast allergy severe claustrophobia, MRI-incompatible prosthesis)