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

• Sponsor: Jonsson Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02224911
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Actual Duration (Months): 61.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is a pilot, feasibility/exploratory study to evaluate the safety of laser interstitial thermal therapy (LITT) using Visualase in the focal treatment of localized prostate cancer as well as to gather data for the design of future studies.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Device: Laser Interstitial Thermal Therapy

Study Design

• Study Type: Observational
• Actual Enrollment: 8 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer: A Pilot Feasibility Study
• Actual Study Start Date: Sep 11, 2014
• Actual Primary Completion Date: Oct 21, 2019
• Actual Study Completion Date: Oct 21, 2019

Arms and Interventions

Arm	Intervention/Treatment
Laser Interstitial Thermal Therapy This is a minimally invasive procedure for focal treatment of prostate cancer.	Device: Laser Interstitial Thermal Therapy

Outcome Measures

Primary Outcome Measures

1. Number of participants with adverse events as a measure of safety and tolerability [12 months]

Secondary Outcome Measures

1. Absence of prostate cancer in the MRI target area as measure of efficacy. [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 85 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States	90095

Sponsors and Collaborators

• Jonsson Comprehensive Cancer Center

Investigators

• Principal Investigator: Pantuck Alan, MD, University of California, Los Angeles
• Principal Investigator: Steven Raman, MD, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

• Carter HB, Kettermann A, Warlick C, Metter EJ, Landis P, Walsh PC, Epstein JI. Expectant management of prostate cancer with curative intent: an update of the Johns Hopkins experience. J Urol. 2007 Dec;178(6):2359-64; discussion 2364-5. Epub 2007 Oct 22.
• Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.

• Responsible Party: Jonsson Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT02224911
• Other Study ID Numbers: 14-000409; JCCCID436; NCI-2015-01487
• First Posted: Aug 25, 2014
• Last Update Posted: Jul 27, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Jonsson Comprehensive Cancer Center: focal therapy; prostate cancer treatment; laser treatment
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Jul 27, 2020