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Focal Laser Ablation of Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Active
Phase
Not Applicable
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 focused on measuring prostrate, ablation

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 =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-guided biopsy with ≥ 10 systematic biopsy cores and ≥ 2 targeted 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)

Sites / Locations

  • University of California at Los Angeles

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Focal Laser Ablation

Arm Description

The 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.

Outcomes

Primary Outcome Measures

Safety based on cumulative adverse events incurred
Safety will be determined by the cumulative number, type, and severity of adverse events incurred by subjects.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2020
Last Updated
January 5, 2023
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04305925
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 16, 2020 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is an open-label early feasibility/pilot study to evaluate the safety and feasibility of the focal laser ablation (FLA) Orion System. Men with histologically confirmed, non-metastatic, prostate adenocarcinoma, clinical stage ≤ T2b, with Gleason score 7 by MRI-ultrasound fusion targeted biopsy, without history of prior treatment and without neoadjuvant radiation or hormone therapy, who desire focal treatment with laser ablation will be enrolled.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Focal Laser Ablation
Arm Type
Experimental
Arm Description
The 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.
Intervention Type
Device
Intervention Name(s)
Focal Laser Ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety based on cumulative adverse events incurred
Description
Safety will be determined by the cumulative number, type, and severity of adverse events incurred by subjects.
Time Frame
From treatment at 1 week, 1 month, and every 3 months until one year.

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
eligibility based on physical existence of prostate.
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 =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-guided biopsy with ≥ 10 systematic biopsy cores and ≥ 2 targeted 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Pantuck, M.D.
Organizational Affiliation
University of California at Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Focal Laser Ablation of Prostate Cancer

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