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

Prostate Cancer Clinical Trial

— LITT  

Official title:

Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer: A Pilot Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02224911
• Other study ID #: 14-000409
• Secondary ID: JCCCID436NCI-201
• Status: Completed
• Start date: September 11, 2014
• Est. completion date: October 21, 2019

Study information

• Verified date: February 2020
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 21, 2019
• Est. primary completion date: October 21, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Laser Interstitial Thermal Therapy

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events as a measure of safety and tolerability		12 months
Secondary	Absence of prostate cancer in the MRI target area as measure of efficacy.		12 months