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Artery Embolization vs Operation of Benign Prostate Hyperplasia (NORTAPE)

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ClinicalTrials.gov Identifier: NCT04084938
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Nils-Einar Kløw, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Post-Op Complication Embolization Therapeutic Transurethral Resection of Prostate Syndrome Procedure: Prostate operation or prostate artery embolization Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized study 1:1
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prostatic Artery Embolization vs Transurethral Resection of the Prostate or Open Prostatectomy in Patients With Symptomatic Benign Prostatic Hyperplasia
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Prostate operation
The patient will have a surgery to remove the prostate gland. The surgery will be done during general anesthesia. Admission will be the day before and after surgery the patients should stay in hospital a few days until being able to go home.
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. Afterwards, you have to stay in bed for 2 hours. Admission will be the day before and discharge the next day or until being able to go home.
Procedure: Prostate operation or prostate artery embolization
As described above.




Primary Outcome Measures :
  1. Quality of life due to urinary symptoms [ Time Frame: 3 months ]
    "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?

  2. Number of patients with Prostate Artery Embolization that did not have prostate operation [ Time Frame: 12 months ]
    We 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).


Secondary Outcome Measures :
  1. Number of patients with postoperative complications [ Time Frame: 3 months ]
    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

  2. Hospital stay [ Time Frame: 3 months ]
    Length of stay including before and after the intervention

  3. Symptoms [ Time Frame: 3 months, 1 year, 5 years ]
    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.


Other Outcome Measures:
  1. Need for catheters [ Time Frame: 3 and 12 months ]
    Number of patients using permanent and intermittent catheters at follow-up will be recorded

  2. Erectile function [ Time Frame: 3 and 12 months ]
    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. Ejaculation [ Time Frame: 3 and 12 months ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084938


Contacts
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Contact: Thijs Hagen, MD + 47 45002349 thihag@ous-hf.no
Contact: Eduard Baco, MD, PHD +47 95221378 Eduard.Baco@medisin.uio.no

Locations
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Norway
Oslo University Hospital, Aker Recruiting
Oslo, Norway
Contact: Thijs Hagen, MD    +4745002349    thihag@ous-hf.no   
Contact: Eduard Baco, MD, PHD    +4795221378    Eduard.Baco@medisin.uio.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         
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Nils Einar Kløw, MD, PHD Department of Radiology, Oslo University Hospital

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Responsible Party: Nils-Einar Kløw, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04084938     History of Changes
Other Study ID Numbers: 2018/1231
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nils-Einar Kløw, Oslo University Hospital:
Prostate
Embolization
Complication
Operation
Randomization
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Postoperative Complications
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male