Artery Embolization vs Operation of Benign Prostate Hyperplasia

Benign Prostatic Hyperplasia Clinical Trial

— NORTAPE  

Official title:

Prostatic Artery Embolization vs Transurethral Resection of the Prostate or Open Prostatectomy in Patients With Symptomatic Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04084938
• Other study ID #: 2018/1231
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2023
• Source: Oslo University Hospital
• Contact: Thijs Hagen, MD
• Phone: + 47 45002349
• Email: thihag[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Embolization Therapeutic
• Hyperplasia
• Post-Op Complication
• Postoperative Complications
• Prostatic Hyperplasia
• Transurethral Resection of Prostate Syndrome

Intervention

Procedure:
• Prostate operation or prostate artery embolization
As described above.

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Aker	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Need for catheters	Number of patients using permanent and intermittent catheters at follow-up will be recorded	3 and 12 months
Other	Erectile function	Change in erectile function will be recoded using the International Index of Erectile Function (IIEF-5) questionnaire. The patients fill in the form before and after treatment. There are 5 questions which score 1-5, 5 is the best. Total score from 5-25.	3 and 12 months
Other	Ejaculation	Change in ejaculation will be recorded using the Male Sexual Questionnaire short form for assessing ejaculation. There are 4 questions with 5-6 possible outcomes.	3 and 12 months
Primary	Quality of life due to urinary symptoms	"Quality of life due to urinary symptoms" QoL = or <3 The scale used: Quality of Life Due to Urinary Symptoms. Scale from 0 to 6, the worse is 6. The patient question: If you were to spend the rest of Your life With Your urinary condition just the way it is now, how would you feel about that?	3 months
Primary	Number of patients with Prostate Artery Embolization that did not have prostate operation	The investigators will record the number of patients that did not have prostate surgery after Prostate Artery Embolization. After 3 months the patients will be offered operation when Quality of Life Due to Urinary Symptoms is 4-6 on the scale from 0-6 ie. the patients report unsatisfied (4), unhappy (5) or terrible (6).	12 months
Secondary	Number of patients with postoperative complications	Postoperative complications will be recorded according to the Clavien-Dindo classification system. Complication will be recorded during hospital stay, at the follow-up after 3 months and at any intermediate points reported by the patients	3 months
Secondary	Hospital stay	Length of stay including before and after the intervention	3 months
Secondary	Symptoms	Change in IPSS. The patients fill in the form International Prostate Symptom Score (IPSS) before and after treatment. Seven questions are scored from 0 to 5, 5 is the worst outcome. Total score from 0 - 35. 1-7 is mild symptoms, 8-19 is moderate symptoms, 20-35 is severe symptoms.	3 months, 1 year, 5 years