Status:
COMPLETED
MRI Guided Transurethral HIFU for Various Prostate Diseases
Lead Sponsor:
Turku University Hospital
Collaborating Sponsors:
University of Turku
Conditions:
Localised Prostate Cancer
Locally Advanced Prostate Cancer
Eligibility:
MALE
Phase:
NA
Brief 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...
Detailed Description
Prostate cancer (PC) is the most common cancer among men in Finland with the highest incidence of all cancers. Benign prostate hyperplasia (BPH) also has high prevalence, increasing with age. BPH may ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT03350529
Start Date
July 24 2017
End Date
May 31 2024
Last Update
November 25 2024
Active Locations (1)
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1
Department of Urology
Turku, Finland, 20521