Testing The TRANBERGCLS|Thermal Therapy for prostate cancer
Official title: MRI Guided Focal Laser Ablation of Prostate Cancer
Interventions
The TRANBERGCLS|Thermal Therapy
MRI Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS\|Thermal Therapy
Canadian Sites (1)
Sangeet Ghai, MD
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 siteTrial siteA hospital or clinic where a study is actually run.Read more → 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
- +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.
Exclusion
- −Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)
- −Medically unfit for focal therapy of the prostate
- −Patients who are unwilling or unable to give informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →;
- −Patients who have received androgen suppression therapy
- −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;
- −Any condition, or history of illness that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → will confound or increase the patient risk during the study
- −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
- −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);
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: The TRANBERGCLS|Thermal Therapy.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 40 years to 80 years.
The study lists male participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 102 people.
The study is currently expected to finish around June 2028.
The main measurement is taken over: 6 months after treatment completion.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
The proportion of study patients clinically free of clinically significant PCa (i.e. requires definitive treatment) — measured over 6 months after treatment completion.
The proportion of study patients clinically free of clinically significant PCa (i.e. requires definitive treatment) — measured over 24 months after treatment completion.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03650595 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About The TRANBERGCLS|Thermal TherapyDevice
MRI Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS\|Thermal Therapy
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 40 years to 80 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 40 years to 80 years.
It lists male participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 6 months after treatment completion.
The study as a whole is currently expected to finish around 2028-06-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 102 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.