Focal Laser Ablation of Prostate Tissue

Status:	Active, not recruiting
Conditions:	Prostate Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	40 - 85
Updated:	5/2/2018
Start Date:	September 17, 2015
End Date:	December 31, 2019

Focal Laser Ablation of Prostate Tissue: A Pilot Feasibility Study Using MRI/US Image Fusion for Guidance

This is an open-label pilot, feasibility/exploratory study to evaluate the safety of laser
interstitial thermal therapy (LITT) using Visualase in the focal ablation of prostate tissue
and to gather data for the design of future studies. Intra-procedure temperature and
concurrent rectal wall thermistor monitoring will be performed for internal validation.
Subjects will be monitored for adverse events, and health-related quality of life (HRQOL)
questionnaires will be obtained. Post-treatment MRI and biopsies will be obtained to evaluate
histologic and radiologic changes. Biomarker (PSA, PCA3 and PHI) kinetics will also be
monitored.

Inclusion Criteria

- Subjects with untreated organ confined prostate cancer (clinical stage ≤ T2b, Gleason
≤ 3+4)

- 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

- MRI-calculated prostate volume 25cc to 100cc

- 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

- Overall Gleason score not to exceed 3+4

- Subjects desire focal therapy and decline conventional treatment (active surveillance,
radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)

- Signed informed consent for the FLA 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 ≥ 3 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

- Inflammatory bowel disease

- Urinary tract or rectal fistula

- Any contraindication to MRI (contrast allergy severe claustrophobia,
MRI-incompatible prosthesis)

We found this trial at

sites

UCLA

Los Angeles, California 90095

(310) 825-4321