Status:
ACTIVE_NOT_RECRUITING
Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-TULSA for Localized Prostate Cancer
Lead Sponsor:
Turku University Hospital
Conditions:
Localized Prostate Cancer
Eligibility:
MALE
18-95 years
Phase:
NA
Brief Summary
Magnetic resonance imaging (MRI) has improved detection of clinically significant prostate cancer (PCa). MRI-guided transurethral ultrasound ablation (MRI-TULSA) system incorporates precise diagnosis ...
Detailed Description
Improving diagnostic methods and screening of men with prostate specific antigen (PSA) has led to earlier detection of prostate cancer (PCa) with more favorable disease characteristics. To decrease ov...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
October 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2028
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03814252
Start Date
October 30 2018
End Date
December 31 2028
Last Update
September 22 2025
Active Locations (1)
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1
Department of Urology, VSSHP, University of Turku
Turku, Finland