MRI Guided Transurethral HIFU for Various Prostate Diseases (NCT03350529) | Clinical Trial Compass
CompletedNot Applicable
MRI Guided Transurethral HIFU for Various Prostate Diseases
Finland87 participantsStarted 2017-07-24
Plain-language summary
This study assesses feasibility and safety, the primary outcomes, of MRI guided transurethral high intensity focused ultrasound (HIFU) ablation for prostate diseases (PD). We will enrol 10 patients to each group with criteria as follows: localised prostate cancer (PC); locally advanced PC; locally recurrent PC after external beam radiation therapy (EBRT); benign prostatic hyperplasia (BPH). Secondary outcomes are both oncologic and functional outcomes and imaging based follow up after HIFU therapy will be also assessed.
Who can participate
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.
Shared inclusion criteria for all groups:
* 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.
* Potential prostate biopsies obtained \> 6 weeks before HIFU/TULSA-PRO treatment (or at the discretion of PI)
* Eligible for MRI
* Eligible for spinal or general anesthesia (ASA 3 or less)
* Succession of urethral catheterization/Patency of prostatic urethra confirmed if needed with pre-HIFU cystoscopy
Group-specific inclusion criteria
Group 1. Localized PC prior to RP
* All localized PC patients planned for robot assisted laparoscopic prostatectomy (RALP) with normal standards of care are eligible for this study (EAU guidelines)
* MRI-visible biopsy proven PC (biopsies obtained \< 6 months before treatment)
Group 2. Locally symptomatic locally advanced and/or metastatic prostate cancer in need of palliative surgical intervention
* gross recurrent hematuria
* bladder outlet obstruction with intractable symptoms
* urinary retention
Group 3. Locally recurrent PC after EBRT as a salvage approach
* Phoenix criteria of biochemical relapse (PSA nadir + 2 ng/ml)
* MRI-visible, biopsy proven local recurrence
* No evidence of distant metastasis in PSMA-PET/CT
Group 4. Symptomatic BPH with need for intervention
* Patients planned for surgical procedure (e.g…
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.
What they're measuring
1
Evaluate targeting accuracy of HIFU ablation separately in each study arm/group.
Timeframe: The date of HIFU treatment
2
Evaluate targeting accuracy volume of HIFU ablation separately in each study arm/group.
Timeframe: The date of HIFU treatment
3
Radiologically determined treatment accuracy of HIFU ablation in localised PC arm/group.
Timeframe: 3-4 weeks from the treatment date
4
Histopathologically determined treatment accuracy of HIFU ablation in localised PC arm/group.
Timeframe: 3-4 weeks from the treatment date
5
Radiologically determined treatment accuracy of HIFU ablation in locally advanced PC arm/group.
Timeframe: 12 months from the treatment date
6
Radiologically determined treatment accuracy of HIFU ablation in locally recurrent PC after EBRT arm/group.