Artery Embolization vs Operation of Benign Prostate Hyperplasia (NORTAPE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Benign Prostatic Hyperplasia; Post-Op Complication; Transurethral Resection of Prostate Syndrome; Embolization Therapeutic
• Intervention / Treatment: Procedure: Prostate operation or prostate artery embolization

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thijs Hagen, MD; Phone Number: + 47 45002349; Email: thihag@ous-hf.no
• Study Contact Backup: Name: Eduard Baco, MD, PHD; Phone Number: +47 95221378; Email: eduaba@online.no

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital, Aker
    • Contact: Thijs Hagen, MD; Phone Number: +4745002349; Email: thihag@ous-hf.no
    • Contact: Eduard Baco, MD, PHD; Phone Number: +4795221378; Email: eduaba@online.no
    • Principal Investigator: Nils Einar Kløw, MD, PHD
    • Sub-Investigator: Ole Jørgen Grøtta, MD, PHD
    • Sub-Investigator: Erik Rud, MD, PHD
    • Sub-Investigator: Gunnar Sandbæk, MD, PHD
    • Sub-Investigator: Dag Bay, MD
    • Sub-Investigator: Truls E Bjerklund Johansen, MD, PHD
    • Sub-Investigator: Rolf Eigil Berg, MD, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prostate operation; 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.	Procedure: Prostate operation or prostate artery embolization; As described above.
Active Comparator: Prostate artery embolization; 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.	Procedure: Prostate operation or prostate artery embolization; As described above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Hospital stay	Length of stay including before and after the intervention	3 months
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for catheters	Number of patients using permanent and intermittent catheters at follow-up will be recorded	3 and 12 months
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
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Nils Einar Kløw, MD, PHD, Department of Radiology, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 7, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Randomization; Prostate; Complication; Embolization; Operation
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia; Postoperative Complications
• Other Study ID Numbers: 2018/1231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No