Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-TULSA for Localized Prostat… (NCT03814252) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-TULSA for Localized Prostate Cancer
Finland62 participantsStarted 2018-10-30
Plain-language 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 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.
Who can participate
Age range
18 Years – 95 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 ultrasou…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.