Micro‑ultrasound guided focal laser treatment for intermediate‑risk prostate cancer
Micro-ultrasound-Guided Focal Laser Ablation (MicroUSgFLA) Treatment for Management of Intermediate-Risk Prostate Cancer: Evaluation of Safety and Effectiveness
This will see if micro‑ultrasound–guided focal laser ablation can safely treat men with intermediate‑risk prostate cancer and delay or avoid surgery or radiation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 7 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | Male |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07339943 on ClinicalTrials.gov |
What this trial studies
This is a single‑arm, prospective 6‑month interventional protocol using transperineal interstitial laser ablation guided by micro‑ultrasound (TRANBERG|CLS system). Men with histologically proven intermediate‑risk prostate cancer and MRI/MicroUS‑visible tumors ≤15 mm confined to one lobe will be enrolled and treated. The study will track safety, functional outcomes (IPSS, ICIQ‑UI‑SF, IIEF‑15), and whether definitive treatments (radical prostatectomy or radiation) can be deferred. The aim is to determine whether micro‑ultrasound guidance can make focal laser therapy simpler and more widely available outside MRI‑dependent centers.
Who should consider this trial
Good fit: Men aged 40–80 with histologically proven intermediate‑risk prostate cancer (Gleason 7), clinical stage T1c–T2, MRI/MicroUS‑visible tumor ≤15 mm in one lobe, PSA <15 ng/mL, and life expectancy over 10 years are ideal candidates.
Not a fit: Patients with tumors >15 mm, multifocal or non‑localized disease, prior androgen‑suppression or chemotherapy for prostate cancer, medical unfitness for focal therapy, or inability to consent are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could let men avoid or postpone major surgery or radiation, preserving urinary and sexual function and quality of life.
How similar studies have performed: MRI‑guided focal therapies, including laser ablation, have shown promising results in select patients, but using micro‑ultrasound as the primary imaging guide is relatively novel and less extensively validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men 40-80 years of age. * Histologically-proven intermediate-risk PCa (Gleason score 7, primary grade ≤ 4). * PCa clinical stage T1c or T2. * MRI/MicroUS site suspicious for cancer or cancer mapped to one prostate lobe. * Maximum dimension of MRI/MicroUS visible tumour ≤15mm. * Suspicious site on Prostate MRI/MicroUS must coincide with sector positive for cancer on biopsy. * Prostate specific antigen (PSA) level \< 15 ng/mL. * IPSS, ICIQ-UI-SF, IIEF-15 questionnaires completed prior to the procedure. * Life expectancy of greater than 10 years, based on co-morbidity not related to PCa. Exclusion Criteria: * Maximum dimension of MRI/MicroUS visible tumour \> 15 mm. * Patients 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 PCa 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)
Where this trial is running
Toronto, Ontario
- University Health Network - Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Sangeet Ghai, MD — The Princess Margaret Cancer Foundation
- Study coordinator: Kateri Corr
- Email: kateri.corr@uhn.ca
- Phone: 416-946-4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.