MRI Guided Transurethral HIFU for Various Prostate Diseases

Criteria the registry did not label

• 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