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)