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Focal Laser Ablation of Prostate Tissue (FLA)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Focal Laser Ablation
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • UCLA
  • University of California Los Angeles

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laser ablation

Arm Description

All patient will undergo focal ablation of prostate tissue utilizing laser energy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 28, 2015
Last Updated
September 17, 2020
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Jean Perkins Foundation, Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT02357121
Brief Title
Focal Laser Ablation of Prostate Tissue
Acronym
FLA
Official Title
Focal Laser Ablation of Prostate Tissue: A Pilot Feasibility Study Using MRI/US Image Fusion for Guidance
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 17, 2015 (Actual)
Primary Completion Date
August 20, 2019 (Actual)
Study Completion Date
August 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Jean Perkins Foundation, Medtronic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser ablation
Arm Type
Experimental
Arm Description
All patient will undergo focal ablation of prostate tissue utilizing laser energy.
Intervention Type
Device
Intervention Name(s)
Focal Laser Ablation
Other Intervention Name(s)
laser treatment
Intervention Description
Focal laser ablation of prostate tissue using laser interstitial thermal therapy (LITT) under MR/ultrasound fusion guidance
Primary Outcome Measure Information:
Title
safety of focal laser treatment using LITT: Number of participants with adverse events
Description
Number of participants with adverse events will be collected in the 12 month follow-up period to assess safety.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Efficacy of focal laser ablation of prostate tissue using the LITT system.
Description
MRI changes will be determined at 6 and 12 months post FLA to assess efficacy.
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard Marks, MD
Organizational Affiliation
University of California at Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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Focal Laser Ablation of Prostate Tissue

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