Clinical trial · Interventional
MRI Guided Transurethral HIFU for Various Prostate Diseases
Feasibility and Safety of Transurethral HIFU in Various Prostate Diseases; Particularly Prostate Cancer
NCT03350529CI-TRIAL-00082943HIFU-PROcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Prostatic Hyperplasia | Benign Prostatic Hyperplasia | ONTOLOGY_EXACT | 0.98 |
| Localised Prostate Cancer | — | UNRESOLVED | — |
| Locally Advanced Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Locally Recurrent Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI guided transurethral HIFU ablation of prostatic tissue | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Localised PC prior to RP
- description
- MRI guided transurethral HIFU ablation is targeted to MRI visible, biopsy proven, index lesion(s) within prostate and if possible with 5mm angular extension (imaging based healthy tissue marginal) to both sides from the tumour boundary in transverse plane and 5 mm in coronal plane. The ablative effect is aimed to reach prostate capsule by heating the control boundary (3 mm from capsule) to temperature 57 °C. The focal approach is intended to be radical as for index lesion.
- interventionNames
- Device: MRI guided transurethral HIFU ablation of prostatic tissue
- type
- EXPERIMENTAL
- label
- Symptomatic locally advanced PC
- description
- MRI guided transurethral HIFU ablation is targeted to main prostatic malignant tumour squeezing and/or invading the prostatic urethra and/or bladder neck. The approach is intended to be palliative.
- interventionNames
- Device: MRI guided transurethral HIFU ablation of prostatic tissue
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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. TURP, laservaporization or open adenomectomy) with normal standards of care are eligible for this study * Bilobular hyperplasia (enlarged transition zone lobes) without dominant enlargement of periurethral zone "median lobe" assessed in cystoscopy and TRUS * No suspicion of cancer on baseline MRI (PI-RADS v2 lesion \< 3) Shared exclusion criteria for all groups: * Prostate calcifications \>1cm in largest diameter located in the anticipated treatment sector on baseline TRUS or MRI * Prostate cysts \>1cm in largest diameter located in the anticipated treatment sector on baseline TRUS or MRI * History of chronic inflammatory conditions (e.g. inflammatory bowel disease) affecting rectum (also includes rectal fistula and anal/rectal stenosis) * Contraindications for MRI (cardiac pacemaker, intracranial clips etc.) * Uncontrolled serious infection * Claustrophobia * Hip replacement surgery or other metal in the pelvic area * Severe kidney failure (glomerular filtration rate (GFR) \<30ml/min/1.73m2) exclude usage of gadolinium in contrast-enhanced imaging unless justifiable based on the clinical judgment of the responsible radiologist and/or urologist. * Known allergy to gadolinium * Known allergy or contraindication to GI anti-spasmodic drug (e.g. glucagon, buscopan) * Inability to insert urinary catheter (i.e. urethral stricture disease) * Patients with artificial urinary sphincter, urethral sling or any penile implant * Any other conditions that might compromise patient safety, based on the clinical judgment of the responsible urologist
References
Publications (48)
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