Artery Embolization vs Operation of Benign Prostate Hyperplasia (NORTAPE)

University of Oslo (UIO)

Status: Enrolling

Conditions: Embolization Therapeutic; Post-Op Complication; Benign Prostatic Hyperplasia; Transurethral Resection of Prostate Syndrome

Treatments: Procedure: Prostate operation or prostate artery embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT04084938

2018/1231

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Prostate operation

Active Comparator group

Description:

You will have a surgery to remove the prostate gland. The surgery will be done during general anesthesia. If your prostate gland is small the surgery will be done through a catheter into the penis. If your prostate gland is large the surgery will be through an incision in your lower abdomen.

Treatment:

Procedure: Prostate operation or prostate artery embolization

Prostate artery embolization

Active Comparator group

Description:

The embolization is done in the Department of Radiology. There will be placement of a catheter into the artery in one of the groins during local anesthesia. Through this catheter small particles will be injected into the arteries of the prostate gland. When finished, the hole in the artery will be closed.

Treatment:

Procedure: Prostate operation or prostate artery embolization