MRI guided laser treatment for early stage prostate cancer
Official title: MRI Guided Focal Laser Ablation of Prostate Cancer
Run by University Health Network, Toronto · NCT03650595 · Data updated 2026-11-12
This study is testing if a new MRI-guided laser treatment can help men with early stage prostate cancer avoid more invasive procedures and still maintain a good quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 80 Years |
| Sex | Men only |
| Enrollment | 102 (estimated) |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | March 29, 2018 |
| Main results expected | December 30, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | June 5, 2026 |
| Trial ID | NCT03650595 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men aged 40-80 with histologically proven low-intermediate risk prostate cancer.
✕Probably not a fit
Patients who have received prior prostate surgery or androgen suppression therapy may not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical research focuses on using MRI guided focal laser ablation (MRgFLA) to treat patients with low to intermediate risk prostate cancer. The study aims to evaluate the effectiveness of this procedure in eliminating or postponing the need for more invasive treatments like radical prostatectomy or radiation therapy. Participants will undergo repeated MRI and prostate biopsy to assess the treatment's success, with previous studies indicating minimal side effects and a high rate of patients remaining on active surveillance. The primary goal is to demonstrate that MRgFLA can safely manage prostate cancer while maintaining quality of life.
Why it matters
Potential benefit: If successful, this treatment could allow patients to avoid more invasive procedures and their associated side effects.
How similar studies have gone: Previous studies have shown promising results for similar approaches, indicating that MRgFLA may be a viable option for managing low-intermediate risk prostate cancer.
Who can join: the full rules
Show full inclusion / exclusion 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 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 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 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); * 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
Where it's running
-
Sangeet Ghai, MD
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Sangeet Ghai, MD — Director; Biopsy Centre, Abdominal Division and Joint Department of Medical Imaging
- Study coordinator: Sangeet Ghai, MD
- Email: sangeet.ghai@uhn.ca
- Phone: 416-340-4800
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.