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Focal Laser Ablation of Prostate Tissue (FLA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02357121
Recruitment Status : Completed
First Posted : February 6, 2015
Last Update Posted : September 21, 2020
Sponsor:
Collaborators:
Jean Perkins Foundation
Medtronic
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Focal Laser Ablation Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Focal Laser Ablation of Prostate Tissue: A Pilot Feasibility Study Using MRI/US Image Fusion for Guidance
Actual Study Start Date : September 17, 2015
Actual Primary Completion Date : August 20, 2019
Actual Study Completion Date : August 20, 2019

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Arms and Interventions
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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 Name: laser treatment


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


Secondary Outcome Measures :
  1. Efficacy of focal laser ablation of prostate tissue using the LITT system. [ Time Frame: 12 months ]
    MRI changes will be determined at 6 and 12 months post FLA to assess efficacy.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357121


Locations
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United States, California
UCLA
Los Angeles, California, United States, 90095
University of California Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Jean Perkins Foundation
Medtronic
Investigators
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Principal Investigator: Leonard Marks, MD University of California at Los Angeles
More Information
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02357121    
Other Study ID Numbers: 15-000018
JCCCID534 ( Other Identifier: Jonsson Comprehensive Cancer Center )
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases