NCT03814252Active, not recruiting
Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-TULSA for Localized Prostate Cancer
Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-guided Transurethral Ultrasound Ablation for Localized Prostate Cancer
Source: ClinicalTrials.gov · Last updated 22 Sept 2025
Brief summary (registry, in English)
Magnetic resonance imaging (MRI) has improved detection of clinically significant prostate cancer (PCa). MRI-guided transurethral ultrasound ablation (MRI-TULSA) system incorporates precise diagnosis and simultaneous ablation of prostate tissue enabling lesion-targeted treatment of PCa. Lesion-based treatment strategy spares surrounding healthy tissues from injury, which may improve the outcome of genitourinary function. This study further investigates the safety and the efficacy of lesion-targeted ablation of MRI-visible biopsy-proven PCa with MRI-TULSA.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 22 Jan 2019
- Start date
- 30 Oct 2018
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Turku University Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT03814252
What you commit to
- Study type: Interventional
- Participants enrolled: 62
- From 30 Oct 2018 to the primary completion date, 31 Dec 2023
- 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.
Other illness
- Contraindications for MRI (cardiac pacemaker, intracranial clips etc.)
- Acute unresolved urinary tract infection
- Claustrophobia
- Hip replacement surgery or other metal in the pelvic area
- Known allergy to gadolinium
- Inability to insert urinary catheter
- Suspected tumor on baseline MRI further than 30 mm or within 3 mm of the prostatic urethra
- Prostate calcifications or cysts obstructing planned ultrasound beam path within the targeted tissue volume
- Any other conditions that might compromise patient safety, based on the clinical judgment of the responsible urologist
Who the study is looking for
- Language spoken: Finnish, English or Swedish
- Mental status: Patients must be able to understand the meaning of the study
- Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff.
- Biopsy-confirmed acinar adenocarcinoma of the prostate
- Gleason score ≥ 3+4/International Society of Urological Pathology grade group ≥ 2
- High volume Gleason score 6 as determined on biopsies (\>2 positive cancer core or ≥ 50% cancer in a core)
- Patient presenting low volume Gleason score 6 disease and refuses active surveillance
- Non-metastatic disease; high-risk patients according to European Association of Urology risk group stratification will undergo F-Prostate specific membrane antigen-Positron Emission Tomography/Computer Tomography to exclude distant metastasis
- Lesion visible on MRI (Prostate Imaging Reporting and Data System v2 4-5)
- Eligible for general anesthesia (American Society of Anesthesiologists (ASA)≤ 3)
Age in the registry: 18 years to 95 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 |
|---|---|---|---|
| Department of Urology, VSSHP, University of Turku Coordinator of this site? Confirm its status | Turku | Finland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.