Focal Laser Ablation of Prostate Tissue (FLA)

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Focal Laser Ablation

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
    • Los Angeles, California, United States, 90095
      • UCLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser ablation; All patient will undergo focal ablation of prostate tissue utilizing laser energy.	Device: Focal Laser Ablation; Focal laser ablation of prostate tissue using laser interstitial thermal therapy (LITT) under MR/ultrasound fusion guidance; Other Names: laser treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety of focal laser treatment using LITT: Number of participants with adverse events	Number of participants with adverse events will be collected in the 12 month follow-up period to assess safety.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of focal laser ablation of prostate tissue using the LITT system.	MRI changes will be determined at 6 and 12 months post FLA to assess efficacy.	12 months

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: Medtronic; Jean Perkins Foundation
• Investigators: Principal Investigator: Leonard Marks, MD, University of California at Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2015
• Primary Completion (Actual): August 20, 2019
• Study Completion (Actual): August 20, 2019

Study Registration Dates

• First Submitted: January 28, 2015
• First Submitted That Met QC Criteria: February 5, 2015
• First Posted (Estimate): February 6, 2015

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 15-000018; JCCCID534 (Other Identifier: Jonsson Comprehensive Cancer Center)