MRI Guided Transurethral HIFU for Various Prostate Diseases (HIFU-PRO)
Localised Prostate Cancer, Locally Advanced Prostate Cancer, Locally Recurrent Prostate Cancer
About this trial
This is an interventional other trial for Localised Prostate Cancer focused on measuring prostate cancer, benign prostatic hyperplasia, benign prostatic obstruction, high intensity focused ultrasound, real-time temperature feedback control, magnetic resonance imaging
Eligibility Criteria
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
Sites / Locations
- Department of Urology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Localised PC prior to RP
Symptomatic locally advanced PC
Locally recurrent PC after EBRT
Symptomatic BPH
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.
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.
MRI guided transurethral HIFU ablation is targeted to MRI visible, biopsy proven, local recurrent index lesion(s) within and/or surrounding prostate and if possible with 5 mm angular extension to either side from the tumour boundary in transverse plane and 5 mm in coronal plane. The approach is intended to be focal and salvage. The whole-gland HIFU ablation approach will be considered in case of extensive organ confined recurrent prostate cancer (positive biopsies for malignancy from extensive/multiple area in prostate and/or extensive/multiple lesion(s) at baseline MRI) to cover whole prostate.
MRI guided transurethral HIFU ablation is targeted to adenomas of the prostate. The HIFU sector encompasses bilateral (anterolateral) transitional zones between bladder neck and verumontanum (colliculus seminalis).