Clinical Trials /

Focal Laser Ablation of Prostate Cancer

NCT04305925

Description:

The primary objective of this study is to evaluate the safety and feasibility of Magnetic-Resonance(MR)-ultrasound image fusion-guided transrectal-based focal laser ablation (FLA) of prostate cancer using the Orion System, an investigational laser-based interstitial irradiation/thermal soft-tissue ablation system. Safety and feasibility will be determined by analyzing the number, type, and severity of adverse events.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Focal Laser Ablation of Prostate Cancer
  • Official Title: Office-based Focal Laser Ablation of Prostate Cancer: An Early Feasibility Study Using MRI/US Image Fusion for Guidance

Clinical Trial IDs

  • ORG STUDY ID: 18-001502
  • SECONDARY ID: 5R01CA218547
  • NCT ID: NCT04305925

Conditions

  • Prostate Cancer

Purpose

The primary objective of this study is to evaluate the safety and feasibility of Magnetic-Resonance(MR)-ultrasound image fusion-guided transrectal-based focal laser ablation (FLA) of prostate cancer using the Orion System, an investigational laser-based interstitial irradiation/thermal soft-tissue ablation system. Safety and feasibility will be determined by analyzing the number, type, and severity of adverse events.

Detailed Description

      The primary objective is to evaluate the safety and feasibility of MR-ultrasound image
      fusion-guided transrectal-based focal laser ablation (FLA) of prostate cancer using the Orion
      System, an investigational laser-based interstitial irradiation/thermal soft-tissue ablation
      system. Safety and feasibility will be determined by analyzing the number, type, and severity
      of adverse events. In addition, changes in health-related quality of life (HRQOL) will be
      evaluated using Expanded Prostate Index Composite for Clinical Practice (EPIC-CP), Memorial
      Anxiety Scale for Prostate Cancer (MAX-PC), and Decision Regret Scale.

      This is an open-label early feasibility/pilot study to evaluate the safety and feasibility of
      the Orion System. In this study, the investigators intend to use the investigational Orion
      system to deploy and monitor thermal energy in cancerous regions of the prostate, identified
      by MRI and confirmed by targeted biopsy. MRI guidance will be achieved by MRI/ultrasound
      fusion, overlaying stored MRI images upon real-time ultrasound images. Interstitial laser
      treatments would be achieved by inserting the fiber into the cancerous regions guided by the
      Artemis image-fusion device. Applications of laser energy up to 15 watts of power will be
      used to treat the target region. Subjects will return to clinic 1 week, 1 month, and every 3
      months until one year post-FLA to be monitored for adverse events and complete Health Related
      Quality of Life (HRQOL) questionnaires. Biomarker (PSA) kinetics will also be monitored.
    

Trial Arms

NameTypeDescriptionInterventions
Focal Laser AblationExperimentalThe Orion system will be used to deploy and monitor thermal energy in cancerous regions of the prostate, identified by MRI and confirmed by targeted biopsy.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Subjects with untreated, organ-confined prostate cancer (FOLQLFDOVWDJH"7E, Gleason =7)
                 x Age 40 to 85 years of age
    
              -  Multi-parametric MRI at University of California at Los Angeles (UCLA) within 6 months
                 of study treatment, demonstrating a Region of interest (ROI) of MRI (PIRADSv2 > Grade
                 3). x Prostate volume 20cc to 80cc
    
              -  Transrectal ultrasound-JXLGHGELRSV\ZLWK V\VWHPDWLFELRSV\FRUHVDQG WDUJHWHG biopsy cores
                 from above MRI-derived ROI within 6 month of biopsy results
    
              -  Histologically-confirmed adenocarcinoma from targeted biopsy cores x Overall Gleason =
                 3+4 or 4+3
    
              -  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
    
            Exclusion Criteria:
    
              -  Any significant cancer outside of the intended treatment zone, defined as Gleason
                 score 7 x < 10 years life expectancy
    
              -  Any medical condition that would compromise the subject's ability to safely ● Active
                 bleeding disorder
    
              -  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 x Active prostate abscess, prostatitis, or neurogenic
                 bladder x Any prior treatment for prostate cancer, including:
    
                   -  Radical prostatectomy
    
                   -  Radiation therapy (external beam or brachytherapy)
    
                   -  Cryotherapy
    
                   -  High intensity focused ultrasound (HIFU) treatment o Photodynamic therapy o
                      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 x Urethral stricture dilation or reconstruction
    
              -  Use of 5-alpha reductase inhibitors within 6 months of treatment x Prior significant
                 rectal surgery (hemorrhoidectomy is acceptable)
    
              -  Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion
                 of transrectal device
    
              -  Inflammatory bowel disease x Urinary tract or rectal fistula x Previous urethral
                 sling, artificial urinary sphincter or penile prosthesis surgery.
    
              -  Any contraindication to MRI (contrast allergy, severe claustrophobia, MRI-incompatible
                 prosthesis, MRI-unsafe aneurysm clips)
          
    Maximum Eligible Age:85 Years
    Minimum Eligible Age:40 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Safety based on cumulative adverse events incurred
    Time Frame:From treatment at 1 week, 1 month, and every 3 months until one year.
    Safety Issue:
    Description:Safety will be determined by the cumulative number, type, and severity of adverse events incurred by subjects.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Jonsson Comprehensive Cancer Center

    Trial Keywords

    • prostrate
    • ablation

    Last Updated

    March 30, 2020