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MRI Guided Focal Laser Ablation of Prostate Cancer (MRgFLA)

Primary Purpose

Prostate Cancer, Low and Intermediate Risk Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
The TRANBERGCLS|Thermal Therapy
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring MRI, Focal Laser Ablation, MR-Guided Focal Laser Ablation

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Men 40-80 years of age;
  • Histologically-proven low-intermediate risk prostate carcinoma; (Gleason score ≤ 7, primary grade ≤ 4)
  • Prostate cancer clinical stage T1c and T2
  • MR site suspicious for cancer or cancer mapped to one lobe of the prostate using the 3D hybrid Trans-rectal ultrasound (TRUS) device
  • Size of MR visible tumor <20mm
  • Suspicious site on Prostate MRI must coincide with sector positive for cancer on biopsy.
  • Prostate specific antigen (PSA) level less than 15 ng/mL
  • IPSS, International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI SF), IIEF complete prior to procedure
  • Life expectancy of greater than 10 years, based on co-morbidity not related to prostate cancer.

Exclusion Criteria:

  • Medically unfit for focal therapy of the prostate
  • Patients who are unwilling or unable to give informed consent;
  • Patients who have received androgen suppression therapy
  • Patients who have received or are receiving chemotherapy for prostate carcinoma;
  • Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive including High-Intensity Focused Ultrasound (HIFU), Transurethral Needle Ablation (TUNA), Radiofrequency Interstitial Tumor Ablation (RITA), microwave, cryotherapy or any curative treatment
  • Patients who have undergone radiation therapy for prostate cancer or to the pelvis
  • Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies);
  • Patients with a history of non compliance with medical therapy and/or medical recommendations;
  • Patients who are unwilling or unable to complete the patient self-assessment questionnaires;
  • Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition.
  • Patients who have participated in a clinical study and/or received treatment with an investigational treatment and/or product within the past 90 days;
  • Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)
  • Any condition, or history of illness that, in the opinion of the investigator will confound or increase the patient risk during the study

Sites / Locations

  • Sangeet Ghai, MDRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm prospective clinical trial

Arm Description

This is a single arm study where patients with low-intermediate risk MR visible locally confined prostate cancer will be treated with focal laser ablation under MRI guidance in the magnet. Following treatment, the patients will be assessed by MRI and Biopsy at 6 months and at 2 years, with PSA assessment at regular intervals during the time

Outcomes

Primary Outcome Measures

The proportion of study patients clinically free of clinically significant PCa (i.e. requires definitive treatment)
Clinically significant PCa will be defined as recurrent/residual Gleason 3+4 or higher, and/or high volume Gleason 6 disease found at 6 month biopsy.
The proportion of study patients clinically free of clinically significant PCa (i.e. requires definitive treatment)
Clinically significant PCa will be defined as recurrent/residual Gleason 3+4 or higher, and/or high volume Gleason 6 disease found at 24 month biopsy.

Secondary Outcome Measures

Treatment effect on patients' Quality of Life (QoL), the following validated self-reported urogenital functioning assessment instruments will be used before and following treatment at pre-specified interval
Validate Patient-Reported Questionnaire (International Prostate Symptom Score, scale from 0-7 mild, 8-19 moderate, 20-35 severe symptoms, higher values being worse, averages at different time points will be noted to assess improvement, decline or baseline) will be completed by participants throughout the study to assess Health Related Quality of Life.
Treatment effect on patients' Quality of Life (QoL), the following validated self-reported urogenital functioning assessment instruments will be used before and following treatment at pre-specified interval
Validate Patient-Reported Questionnaire (International Index of Erectile Function-15, higher scores are better, averages at each specified interval will be taken once all subjects reach the interval and study completion) will be completed by participants throughout the study to assess Health Related Quality of Life.

Full Information

First Posted
August 10, 2018
Last Updated
August 19, 2020
Sponsor
University Health Network, Toronto
Collaborators
Clinical Laserthermia Systems AB
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1. Study Identification

Unique Protocol Identification Number
NCT03650595
Brief Title
MRI Guided Focal Laser Ablation of Prostate Cancer
Acronym
MRgFLA
Official Title
MRI Guided Focal Laser Ablation of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 29, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Clinical Laserthermia Systems AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical research study is designed to determine the ability of in bore MRI guided Focal Laser Ablation (MRgFLA) in patients with early stage carcinoma of prostate. The results will be evaluated by repeated MRI and prostate biopsy. Previous prospective development study demonstrated that FLA may be a viable option for men with low-intermediate risk prostate cancer. The vast majority of patients undergoing this treatment experienced minimal side effects with no peri-operative complications. Over 80% of patients treated with MRgFLA remain on AS and were able to avoid radical therapy at mean follow up duration of 3 years.
Detailed Description
Study Objectives are to evaluate the proportion of patients with low-intermediate risk prostate cancer undergoing focal laser ablation (MRgFLA) prostate treatment who will be free of clinically significant Prostate Cancer (PCa), when using a > 5mm margins around the MR visible tumor in defining the ablation contour. The rationale of the study is to show that MRgFLA is a safe procedure that can significantly postpone or eliminate the need for patients with Low-Intermediate Risk prostate cancer to undergo a definitive treatment (i.e., Radical Prostatectomy or Radiation therapy) for their disease. Study population: patients with Low-Intermediate Risk Prostate Cancer who are willing to take part in the study and meet study eligibility criteria. Primary Study Objective is to show that MRgFLA can significantly reduce the need for definitive treatment (e.g., Radical Prostatectomy, or Radiation therapy) and is a safe procedure for patients with Low-Intermediate Risk Prostate Cancer defined in the current protocol as 1) Gleason score 6 and 7 (=3+4 or 4+3; No Grade 5 pattern), and 2) T1-T2, N0, M0.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Low and Intermediate Risk Prostate Cancer
Keywords
MRI, Focal Laser Ablation, MR-Guided Focal Laser Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, open-label single-arm effectiveness study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm prospective clinical trial
Arm Type
Experimental
Arm Description
This is a single arm study where patients with low-intermediate risk MR visible locally confined prostate cancer will be treated with focal laser ablation under MRI guidance in the magnet. Following treatment, the patients will be assessed by MRI and Biopsy at 6 months and at 2 years, with PSA assessment at regular intervals during the time
Intervention Type
Device
Intervention Name(s)
The TRANBERGCLS|Thermal Therapy
Intervention Description
MRI Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS|Thermal Therapy
Primary Outcome Measure Information:
Title
The proportion of study patients clinically free of clinically significant PCa (i.e. requires definitive treatment)
Description
Clinically significant PCa will be defined as recurrent/residual Gleason 3+4 or higher, and/or high volume Gleason 6 disease found at 6 month biopsy.
Time Frame
6 months after treatment completion
Title
The proportion of study patients clinically free of clinically significant PCa (i.e. requires definitive treatment)
Description
Clinically significant PCa will be defined as recurrent/residual Gleason 3+4 or higher, and/or high volume Gleason 6 disease found at 24 month biopsy.
Time Frame
24 months after treatment completion
Secondary Outcome Measure Information:
Title
Treatment effect on patients' Quality of Life (QoL), the following validated self-reported urogenital functioning assessment instruments will be used before and following treatment at pre-specified interval
Description
Validate Patient-Reported Questionnaire (International Prostate Symptom Score, scale from 0-7 mild, 8-19 moderate, 20-35 severe symptoms, higher values being worse, averages at different time points will be noted to assess improvement, decline or baseline) will be completed by participants throughout the study to assess Health Related Quality of Life.
Time Frame
Baseline before treatment, 30 days, 6 months, 12 months and at 24 months following treatment
Title
Treatment effect on patients' Quality of Life (QoL), the following validated self-reported urogenital functioning assessment instruments will be used before and following treatment at pre-specified interval
Description
Validate Patient-Reported Questionnaire (International Index of Erectile Function-15, higher scores are better, averages at each specified interval will be taken once all subjects reach the interval and study completion) will be completed by participants throughout the study to assess Health Related Quality of Life.
Time Frame
Baseline before treatment, 30 days, 6 months, 12 months and at 24 months following treatment

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Men with prostate cancer
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men 40-80 years of age; Histologically-proven low-intermediate risk prostate carcinoma; (Gleason score ≤ 7, primary grade ≤ 4) Prostate cancer clinical stage T1c and T2 MR site suspicious for cancer or cancer mapped to one lobe of the prostate using the 3D hybrid Trans-rectal ultrasound (TRUS) device Size of MR visible tumor <20mm Suspicious site on Prostate MRI must coincide with sector positive for cancer on biopsy. Prostate specific antigen (PSA) level less than 15 ng/mL IPSS, International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI SF), IIEF complete prior to procedure Life expectancy of greater than 10 years, based on co-morbidity not related to prostate cancer. Exclusion Criteria: Medically unfit for focal therapy of the prostate Patients who are unwilling or unable to give informed consent; Patients who have received androgen suppression therapy Patients who have received or are receiving chemotherapy for prostate carcinoma; Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive including High-Intensity Focused Ultrasound (HIFU), Transurethral Needle Ablation (TUNA), Radiofrequency Interstitial Tumor Ablation (RITA), microwave, cryotherapy or any curative treatment Patients who have undergone radiation therapy for prostate cancer or to the pelvis Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies); Patients with a history of non compliance with medical therapy and/or medical recommendations; Patients who are unwilling or unable to complete the patient self-assessment questionnaires; Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition. Patients who have participated in a clinical study and/or received treatment with an investigational treatment and/or product within the past 90 days; Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent) Any condition, or history of illness that, in the opinion of the investigator will confound or increase the patient risk during the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sangeet Ghai, MD
Phone
416-340-4800
Ext
3385
Email
sangeet.ghai@uhn.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Kateri Corr, RN
Phone
416-946-4501
Ext
5501
Email
kateri.corr@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangeet Ghai, MD
Organizational Affiliation
Director; Biopsy Centre, Abdominal Division and Joint Department of Medical Imaging
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sangeet Ghai, MD
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sangeet Ghai, MD
Phone
416-340-4800
Ext
3385
Email
sangeet.ghai@uhn.ca
First Name & Middle Initial & Last Name & Degree
Kateri Corr, RN
Phone
416-946-4501
Ext
5501
Email
kateri.corr@uhn.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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MRI Guided Focal Laser Ablation of Prostate Cancer

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