NCT07339943Recruiting
Micro-ultrasound-Guided Focal Laser Ablation for Intermediate-Risk Prostate Cancer: Safety & Effectiveness
Micro-ultrasound-Guided Focal Laser Ablation (MicroUSgFLA) Treatment for Management of Intermediate-Risk Prostate Cancer: Evaluation of Safety and Effectiveness
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
This clinical research study is intended to show that Micro-Ultrasound Guided Focal Laser Ablation (MicroUSgFLA) is a safe procedure that can significantly postpone or eliminate the need for patients with intermediate-Risk prostate cancer (PCa) to undergo a definitive treatment (i.e., Radical Prostatectomy or Radiation Therapy) for their disease.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 7 (estimated)
- First submitted
- 4 Sept 2025
- Start date
- 30 Apr 2025
- Primary completion date
- 31 May 2028
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Prostate cancer
- NCT number
- NCT07339943
What you commit to
- Study type: Interventional
- Planned participants: 7
- From 30 Apr 2025 to the primary completion date, 31 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients medically unfit for focal therapy of the prostate.
- 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.
- Patients who have participated in a clinical study and/or received treatment with an investigational treatment and/or product within the past 90 days.
Other illness
- 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.
- Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition.
- Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)
Other
- Maximum dimension of MRI/MicroUS visible tumour \> 15 mm.
- Patients who are unwilling or unable to give informed consent.
- Patients who are unwilling or unable to complete the patient self-assessment questionnaires.
Who the study is looking for
- 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.
Age in the registry: 40 years to 85 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health Network - Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.