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Artery Embolization vs Operation of Benign Prostate Hyperplasia (NORTAPE)

Primary Purpose

Benign Prostatic Hyperplasia, Post-Op Complication, Embolization Therapeutic

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Prostate operation or prostate artery embolization
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Prostate, Embolization, Complication, Operation, Randomization

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Oslo University Hospital, AkerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Prostate operation

Prostate artery embolization

Arm 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.

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.

Outcomes

Primary Outcome Measures

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?
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).

Secondary Outcome Measures

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
Hospital stay
Length of stay including before and after the intervention
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.

Full Information

First Posted
September 4, 2019
Last Updated
December 8, 2020
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04084938
Brief Title
Artery Embolization vs Operation of Benign Prostate Hyperplasia
Acronym
NORTAPE
Official Title
Prostatic Artery Embolization vs Transurethral Resection of the Prostate or Open Prostatectomy in Patients With Symptomatic Benign Prostatic Hyperplasia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia, Post-Op Complication, Embolization Therapeutic, Transurethral Resection of Prostate Syndrome
Keywords
Prostate, Embolization, Complication, Operation, Randomization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized study 1:1
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prostate operation
Arm Type
Active Comparator
Arm 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.
Arm Title
Prostate artery embolization
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Prostate operation or prostate artery embolization
Intervention Description
As described above.
Primary Outcome Measure Information:
Title
Quality of life due to urinary symptoms
Description
"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?
Time Frame
3 months
Title
Number of patients with Prostate Artery Embolization that did not have prostate operation
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of patients with postoperative complications
Description
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
Time Frame
3 months
Title
Hospital stay
Description
Length of stay including before and after the intervention
Time Frame
3 months
Title
Symptoms
Description
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.
Time Frame
3 months, 1 year, 5 years
Other Pre-specified Outcome Measures:
Title
Need for catheters
Description
Number of patients using permanent and intermittent catheters at follow-up will be recorded
Time Frame
3 and 12 months
Title
Erectile function
Description
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.
Time Frame
3 and 12 months
Title
Ejaculation
Description
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.
Time Frame
3 and 12 months

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thijs Hagen, MD
Phone
+ 47 45002349
Email
thihag@ous-hf.no
First Name & Middle Initial & Last Name or Official Title & Degree
Eduard Baco, MD, PHD
Phone
+47 95221378
Email
eduaba@online.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nils Einar Kløw, MD, PHD
Organizational Affiliation
Department of Radiology, Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital, Aker
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thijs Hagen, MD
Phone
+4745002349
Email
thihag@ous-hf.no
First Name & Middle Initial & Last Name & Degree
Eduard Baco, MD, PHD
Phone
+4795221378
Email
eduaba@online.no
First Name & Middle Initial & Last Name & Degree
Nils Einar Kløw, MD, PHD
First Name & Middle Initial & Last Name & Degree
Ole Jørgen Grøtta, MD, PHD
First Name & Middle Initial & Last Name & Degree
Erik Rud, MD, PHD
First Name & Middle Initial & Last Name & Degree
Gunnar Sandbæk, MD, PHD
First Name & Middle Initial & Last Name & Degree
Dag Bay, MD
First Name & Middle Initial & Last Name & Degree
Truls E Bjerklund Johansen, MD, PHD
First Name & Middle Initial & Last Name & Degree
Rolf Eigil Berg, MD, PHD

12. IPD Sharing Statement

Plan to Share IPD
No

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Artery Embolization vs Operation of Benign Prostate Hyperplasia

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