Actively Recruiting
MRI Guided Focal Laser Ablation of Prostate Cancer Using The TRANBERGCLS Thermal Therapy Device for Low and Intermediate Risk Prostate Cancer
Led by University Health Network, Toronto · Updated on 2026-06-05
102
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
C
Clinical Laserthermia Systems AB
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the use of MRI guided Focal Laser Ablation (MRgFLA) in men with early stage, low to intermediate risk prostate cancer. The study focuses on determining how well MRgFLA can control prostate cancer while reducing the need for more invasive treatments like surgery or radiation. Previous studies suggest that MRgFLA may be a safe option with minimal side effects and help many patients avoid radical therapies over several years. Participants will receive focal laser ablation treatment guided by MRI, targeting the visible tumor with a margin around it to ensure thorough treatment. This is a single arm study where all patients will undergo the MRgFLA procedure using The TRANBERGCLS|Thermal Therapy device. After treatment, patients will have follow-up MRI scans and prostate biopsies at 6 months and 2 years, along with regular PSA blood tests to monitor cancer status. During the study, researchers will assess the presence of clinically significant prostate cancer using MRI and biopsy results. Patients will also complete validated questionnaires measuring urinary and sexual function before and at several points after treatment to track quality of life changes. The total monitoring period includes evaluations at 6 months, 12 months, and 24 months after treatment, allowing detailed assessment of treatment effects and safety over time.
CONDITIONS
Brief Title
MRI Guided Focal Laser Ablation of Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men 40 to 80 years of age
- Histologically confirmed low to intermediate risk prostate cancer (Gleason score 4, primary grade 4)
- Prostate cancer clinical stage T1c or T2
- MRI visible tumor smaller than 20 mm
- Suspicious MRI site must match positive biopsy sector
- Prostate specific antigen (PSA) level below 15 ng/mL
- Complete IPSS, ICIQ-UI-SF, and IIEF questionnaires before procedure
- Life expectancy greater than 10 years unrelated to prostate cancer
You will not qualify if you...
- Medically unfit for focal prostate therapy
- Unable or unwilling to give informed consent
- Previous androgen suppression therapy
- Previous or current chemotherapy for prostate cancer
- Prior prostate surgery or curative treatments (including HIFU, TUNA, RITA, microwave, cryotherapy)
- Previous radiation therapy for prostate or pelvis
- Conditions or illnesses posing additional risk or confounding results (e.g., significant cardiovascular issues, allergies)
- History of noncompliance with medical recommendations
- Unable or unwilling to complete self-assessment questionnaires
- Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or symptoms preventing normal urination
- Participation in another investigational study or treatment within past 90 days
- Contraindications to MRI (e.g., pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast)
- Any condition that may increase risks or confound study results as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive MRI guided focal laser ablation treatment of prostate cancer using the TRANBERGCLS thermal therapy device.
1 treatment visit (in-person)
Duration - Up to 24 months
Participants are assessed by MRI and biopsy at 6 months and 24 months after treatment, with regular PSA assessments during this period.
Visits at 30 days, 6 months, 12 months, and 24 months post-treatment
Trial Site Locations
Total: 1 location
1
Sangeet Ghai, MD
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
S
Sangeet Ghai, MD
K
Kateri Corr, RPN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here