Prostate CancerMRgFLANCT03650595
MRI Guided Focal Laser Ablation of Prostate Cancer
A study testing The TRANBERGCLS|Thermal Therapy in people with Prostate Cancer and Low and Intermediate Risk Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Low and Intermediate Risk Prostate Cancer
- What is being tested?
- The TRANBERGCLS|Thermal Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteCanada
- Study dates
- 29 Mar 2018to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 TRUS device
- Size of MR visible tumor <20mm
- Suspicious site on Prostate MRI must coincide with sector positive for cancer on biopsy
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- Prostate specific antigen (PSA) level <15 ng/mL
- IPSS, ICIQ-UI-SF, IIEF complete prior to procedure
- Life expectancy of greater than 10 years, based on co-morbidity not related to prostate cancer.
Who cannot join
- 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 HIFU, TUNA, RITA, microwave, cryotherapy or any curative treatment
- Patients who have undergone radiation therapy for prostate cancer or to the pelvis
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- 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 noncompliance 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sangeet Ghai, MD
Toronto, Ontario, M5G 2M9
Sangeet Ghai, MD, 416-340-4656, sangeet.ghai@uhn.ca
Kateri Corr, RPN, 416-946-4501 ext. 5501, kateri.corr@uhn.ca
About this study
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.
Read the 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.
- Being tested
- The TRANBERGCLS|Thermal Therapy
- Keywords
- MRI, Focal Laser Ablation, MR-Guided Focal Laser Ablation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The TRANBERGCLS|Thermal TherapyDevice
MRI Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS|Thermal Therapy
| Study group | Role | What they receive |
|---|---|---|
| Single arm prospective clinical trial | Experimental | 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 Receives: Device: The TRANBERGCLS|Thermal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after treatment completion
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.
Measured: 24 months after treatment completion
Secondary outcomes (2)
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.
Measured: Baseline before treatment, 30 days, 6 months, 12 months and at 24 months following treatment
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.
Measured: Baseline before treatment, 30 days, 6 months, 12 months and at 24 months following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start29 Mar 2018
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 24 Month, Prospective, Interventional, Open-label Single-Arm Effectiveness Study
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Laserthermia Systems AB
- Responsible party
- Sponsor
- Investigators
- Sangeet Ghai, MD, Principal investigator, Director; Biopsy Centre, Abdominal Division and Joint Department of Medical Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650595
- Sponsor's protocol ID
- 15-9002
- Acronym
- MRgFLA
- Status last verified
- Jun 2026
- First submitted
- 10 Aug 2018
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Guided Focal Laser Ablation of Prostate Cancer
- ClinicalTrials.gov ID
- NCT03650595
- Acronym / sponsor ID
- MRgFLA / 15-9002
- Keywords
- MRI, Focal Laser Ablation, MR-Guided Focal Laser Ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Clinical Laserthermia Systems AB
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 28 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 24 Month, Prospective, Interventional, Open-label Single-Arm Effectiveness Study
| Arm | Type | Receives |
|---|---|---|
| Single arm prospective clinical trial | Experimental | Device: The TRANBERGCLS|Thermal TherapyThis 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 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 TRUS device
- Size of MR visible tumor <20mm
Key exclusion criteria (13 listed)
- 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 HIFU, TUNA, RITA, microwave, cryotherapy or any curative treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The TRANBERGCLS|Thermal TherapyMRI Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS|Thermal Therapy | Device | Single arm prospective clinical trial |
Primary outcome
The proportion of study patients clinically free of clinically significant PCa (i.e. requires definitive treatment)
Time frame: 6 months after treatment completion
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)
Time frame: 24 months after treatment completion
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.
2 secondary outcomes
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
Time frame: Baseline before treatment, 30 days, 6 months, 12 months and at 24 months following treatment
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
Time frame: Baseline before treatment, 30 days, 6 months, 12 months and at 24 months following treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sangeet Ghai, MD principal investigator
Director; Biopsy Centre, Abdominal Division and Joint Department of Medical Imaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The TRANBERGCLS|Thermal Therapy in people with Prostate Cancer and Low and Intermediate Risk Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sangeet Ghai, MD (416-340-4800 ext. 3385, sangeet.ghai@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of study patients clinically free of clinically significant PCa (i.e. requires definitive treatment) (time frame: 6 months after treatment completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.