Clinical trial NCT04084938: Artery Embolization vs Operation of Benign Prostate Hyperplasia
Official title: Prostatic Artery Embolization vs Transurethral Resection of the Prostate or Open Prostatectomy in Patients With Symptomatic Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Post-Op Complication
Embolization Therapeutic
Transurethral Resection of Prostate Syndrome
Keywords: Prostate
Embolization
Complication
Operation
Randomization
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 140
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized study 1:1
Primary purpose: TREATMENT

Brief summary: Aim of the study is to compare prostate artery embolization (PAE) to the established surgical treatment for patient acceptance, morbidity, complications, and the functional outcomes. To compare length of stay, hospital costs and time for recovery. 140 patients will be randomized to PAE or surgery. Patients should suffer from lower urinary tract symptoms (LUTS), be candidates for both treatments and willing to undergo both procedures. Before randomization computed tomography angiography of the pelvic arteries is done to select eligible patients. Magnetic resonance imaging of prostate rules out possible cancer. The PAE is done in the angio suite in the radiology department injecting small particles into the prostate arteries. The surgery is done in the operation room in the urology department according to established procedures. Clinical follow-up include clinical visit after 3 months, 1 and 5 years. Acute as well as long term complications will be recorded.

Detailed description: Background: Prostatic artery embolization (PAE) has recently been described as a promising alternative to surgery for treatment of lower urinary tract symptoms (LUTS) due to an enlarged, benign prostate. The treatment has not been implemented into international guidelines and has only been introduced to few patients in Norway.

Purpose: To compare PAE to the established surgical treatment for patient acceptance, morbidity, complications, and the functional outcomes. To compare length of stay, hospital costs and time for recovery.

Materials and Methods: 140 patients will be randomized to PAE or surgery. Patients should suffer from LUTS, be candidates for both treatments and willing to undergo both procedures. Before randomization computed tomography angiography of the pelvic arteries is done to select eligible patients. Magnetic resonance imaging of prostate rules out possible cancer. The PAE is done in the angio suite in the radiology department injection small particles into the prostate arteries. The surgery is done in the operation room in the urology department according to established procedures. All patients stay in the urology unit after the procedure. Clinical follow-up include clinical visit after 3 months, 1 and 5 years. Acute as well as long term complications will be recorded. The patients fill in the form of quality of life from urologic disease. Urodynamic examination will record functional outcome. Length of stay, procedure costs and recovery time will be recorded.

Importance of the study: Contribute to establishment of new treatment and help to select the right patients for the alternative treatments. Randomized study will give important information to the international community. It is possible to run this study in Norway because it is still in limited use.

Eligibility criteria: Inclusion Criteria:

* LUTS from Benign Prostate Hyperplasia (BPH) with moderate and severe IPSS score (IPSS \> 8) and QoL = or \>3
* and refractory to medical treatment for at least 6 months or the patient is unwilling to accept medical treatment
* or BPH using permanent or intermittent catheterization
* Prostate volume \> 50 ml
* Signed informed consent

Exclusion Criteria:

* Urological disorders: evidence of clinically significant prostate cancer \[as defined by START criteria\] on prostate biopsy (27,28), prostatitis (29,30), detrusor-sphincter dyssynergia or evidence of neurogenic bladder, urethral strictures, bladder neck contracture, bladder stone or bladder cancer
* Renal insufficiency defined as Glomerular Filtration Rate \< 30 ml/min/1,73m2
* Known severe reactions to iodine-based contrast or gadolinium-based contrast
* Previous prostate operation
* CT examination reveals no access to the prostate arteries.

Primary outcomes:
measure: Quality of life due to urinary symptoms
timeFrame: 3 months
measure: Number of patients with Prostate Artery Embolization that did not have prostate operation
timeFrame: 12 months
Secondary outcomes:
measure: Number of patients with postoperative complications
timeFrame: 3 months
measure: Hospital stay
timeFrame: 3 months
measure: Symptoms
timeFrame: 3 months, 1 year, 5 years
Other outcomes:
measure: Need for catheters
timeFrame: 3 and 12 months
measure: Erectile function
timeFrame: 3 and 12 months
measure: Ejaculation
timeFrame: 3 and 12 months
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Aker
Study officials:
affiliation: Department of Radiology, Oslo University Hospital
name: Nils Einar Kløw, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: