EMPATHY: Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH

Sponsor

Dominik Abt (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04245566

Collaborator

(none)

425

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study compares safety and efficacy of prostatic artery embolization and pharmacotherapy in the treatment of lower urinary tract symptoms associated wit benign prostatic hyperplasia.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia Pharmacotherapy Prostatic Artery Embolization Minimally Invasive Treatment	Procedure: Prostatic Artery Embolization (PAE) Drug: Pharmacotherapy	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

425 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1 randomized controlled study1:1 randomized controlled study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prostatic Artery Embolization vs. Pharmacotherapy for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: a Multicenter Randomized Controlled Trial

Anticipated Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prostatic Artery Embolization (PAE) PAE will be performed as an inpatient or outpatient procedure by interventional radiologists who are familiar with the procedure and according to established techniques. A unilateral femoral sheath is placed in the right common femoral artery under local anaesthesia. The prostatic arterial supply is identified by selective internal iliac arteriography. Prostatic arteries are selectively catheterised and embolised by use of 250-600 μm microspheres . PAE is performed bilaterally if possible and considered successful in the absence of the normal blush of the prostate and stasis of flow in the prostate arteries on angiography after embolisation.	Procedure: Prostatic Artery Embolization (PAE) Prostatic artery embolization will be performed under local anesthesia according to well established and standardized techniques.
Placebo Comparator: Pharmocotherapy Pharmacotherapy will be performed using α1-blockers and 5α-reductase inhibitors in accordance with the EAU recommendations. Thus, patients with a prostate size smaller than 40mL will be treated with 0.4 mg tamsulosin once daily, while patients with larger prostates will be treated with 0.4 mg tamsulosin plus 0.5 mg dutasteride once daily during the complete study follow-up.	Drug: Pharmacotherapy Pharmacotherapy will be performed using α1-blockers and 5α-reductase inhibitors in accordance with the EAU recommendations

Arm

Intervention/Treatment

Experimental: Prostatic Artery Embolization (PAE)

PAE will be performed as an inpatient or outpatient procedure by interventional radiologists who are familiar with the procedure and according to established techniques. A unilateral femoral sheath is placed in the right common femoral artery under local anaesthesia. The prostatic arterial supply is identified by selective internal iliac arteriography. Prostatic arteries are selectively catheterised and embolised by use of 250-600 μm microspheres . PAE is performed bilaterally if possible and considered successful in the absence of the normal blush of the prostate and stasis of flow in the prostate arteries on angiography after embolisation.

Procedure: Prostatic Artery Embolization (PAE)

Prostatic artery embolization will be performed under local anesthesia according to well established and standardized techniques.

Placebo Comparator: Pharmocotherapy

Pharmacotherapy will be performed using α1-blockers and 5α-reductase inhibitors in accordance with the EAU recommendations. Thus, patients with a prostate size smaller than 40mL will be treated with 0.4 mg tamsulosin once daily, while patients with larger prostates will be treated with 0.4 mg tamsulosin plus 0.5 mg dutasteride once daily during the complete study follow-up.

Drug: Pharmacotherapy

Pharmacotherapy will be performed using α1-blockers and 5α-reductase inhibitors in accordance with the EAU recommendations

Outcome Measures

Primary Outcome Measures

International Prostate Symptoms Score (IPSS) [24 months after treatment initiation]
The International Prostate Symptoms Score (IPSS) measures the degree of symptoms associated with benign prostatic hyperplasia (BPH). Range of values 0-35 points. Higher values indicate more severe symptoms.

Secondary Outcome Measures

International Prostate Symptoms Score (IPSS) [6 weeks after treatment initiation]
The International Prostate Symptoms Score (IPSS) measures the degree of symptoms associated with benign prostatic hyperplasia (BPH). Range of values 0-35 points. Higher values indicate more severe symptoms.
International Prostate Symptoms Score (IPSS) [6 months after treatment initiation]
The International Prostate Symptoms Score (IPSS) measures the degree of symptoms associated with benign prostatic hyperplasia (BPH). Range of values 0-35 points. Higher values indicate more severe symptoms.
International Prostate Symptoms Score (IPSS) [1 year after treatment initiation]
The International Prostate Symptoms Score (IPSS) measures the degree of symptoms associated with benign prostatic hyperplasia (BPH). Range of values 0-35 points. Higher values indicate more severe symptoms.
International Prostate Symptoms Score (IPSS) [5 year after treatment initiation]
The International Prostate Symptoms Score (IPSS) measures the degree of symptoms associated with benign prostatic hyperplasia (BPH). Range of values 0-35 points. Higher values indicate more severe symptoms.
Self-assessed goal achievement (SAGA) [6 weeks after treatment initiation]
SAGA is a PROM focusing on individual treatment goals SAGA is a patient reported outcome measure focusing on individual treatment goals
Self-assessed goal achievement (SAGA) [6 months after treatment initiation]
SAGA is a PROM focusing on individual treatment goals SAGA is a patient reported outcome measure focusing on individual treatment SAGA is a PROM focusing on individual treatment goals
Self-assessed goal achievement (SAGA) [1 year after treatment initiation]
SAGA is a PROM focusing on individual treatment goals SAGA is a patient reported outcome measure focusing on individual treatment goals
Self-assessed goal achievement (SAGA) [2 years after treatment initiation]
SAGA is a PROM focusing on individual treatment goals SAGA is a patient reported outcome measure focusing on individual treatment goals
Self-assessed goal achievement (SAGA) [5 years after treatment initiation]
SAGA is a PROM focusing on individual treatment goals SAGA is a patient reported outcome measure focusing on individual treatment goals
Maximum urinary stream (Qmax) [6 weeks after treatment initiation]
Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.
Maximum urinary stream (Qmax) [6 months after treatment initiation]
Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.
Maximum urinary stream (Qmax) [1 year after treatment initiation]
Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.
Maximum urinary stream (Qmax) [2 years after treatment initiation]
Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.
Maximum urinary stream (Qmax) [5 years after treatment initiation]
Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.
Post void residual urine (PVR) [6 weeks after treatment initiation]
Post void residual is measured after voiding by transabdominal ultrasound and calculated in mL. Higher values indicate more post void residual urine and a worse ability to empty the bladder.
Post void residual urine (PVR) [6 months after treatment initiation]
Post void residual is measured after voiding by transabdominal ultrasound and calculated in mL. Higher values indicate more post void residual urine and a worse ability to empty the bladder.
Post void residual urine (PVR) [1 year after treatment initiation]
Post void residual is measured after voiding by transabdominal ultrasound and calculated in mL. Higher values indicate more post void residual urine and a worse ability to empty the bladder.
Post void residual urine (PVR) [2 years after treatment initiation]
Post void residual is measured after voiding by transabdominal ultrasound and calculated in mL. Higher values indicate more post void residual urine and a worse ability to empty the bladder.
Post void residual urine (PVR) [5 years after treatment initiation]
Post void residual is measured after voiding by transabdominal ultrasound and calculated in mL. Higher values indicate more post void residual urine and a worse ability to empty the bladder.
Prostate volume [6 moths after treatment initiation]
Prostate volume measured by transrectal ultrasound. This examination is only performed at selected food-up visits (i.e. 6mo, 2y, 5y)
Prostate volume [2 years after treatment initiation]
Prostate volume measured by transrectal ultrasound. This examination is only performed at selected food-up visits (i.e. 6mo, 2y, 5y)
Prostate volume [5 years after treatment initiation]
Prostate volume measured by transrectal ultrasound. This examination is only performed at selected food-up visits (i.e. 6mo, 2y, 5y)
Prostate specific antigen (PSA) [6 months after treatment initiation]
laboratory test
Prostate specific antigen (PSA) [1 year after treatment initiation]
laboratory test
Prostate specific antigen (PSA) [2 years after treatment initiation]
laboratory test
Prostate specific antigen (PSA) [5 years after treatment initiation]
laboratory test
Safety / adverse events [6 weeks after treatment initiation]
Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
Safety / adverse events [6 months after treatment initiation]
Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
Safety / adverse events [1 year after treatment initiation]
Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
Safety / adverse events [2 year after treatment initiation]
Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
Safety / adverse events [5 year after treatment initiation]
Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
Erectile function [6 weeks after treatment initiation]
Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.
Erectile function [6 months after treatment initiation]
Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.
Erectile function [1 year after treatment initiation]
Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.
Erectile function [2 year after treatment initiation]
Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.
Erectile function [5 year after treatment initiation]
Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.
Ejaculatory function [6 weeks after treatment initiation]
Assessed by the questionnaire Male Sexual Health Questionnaire-Ejaculation Dysfunction Short Form (MSHQ-EjD). Ejaculatory function total score (questions 1-3, possible range 0-15, higher values indicate better ejaculatory function, and MSHQ-EjD ejaculatory bother item (question 4, possible range 0-5, higher values indicate more bother).
Ejaculatory function [6 months after treatment initiation]
Assessed by the questionnaire Male Sexual Health Questionnaire-Ejaculation Dysfunction Short Form (MSHQ-EjD). Ejaculatory function total score (questions 1-3, possible range 0-15, higher values indicate better ejaculatory function, and MSHQ-EjD ejaculatory bother item (question 4, possible range 0-5, higher values indicate more bother).
Ejaculatory function [1 year after treatment initiation]
Assessed by the questionnaire Male Sexual Health Questionnaire-Ejaculation Dysfunction Short Form (MSHQ-EjD). Ejaculatory function total score (questions 1-3, possible range 0-15, higher values indicate better ejaculatory function, and MSHQ-EjD ejaculatory bother item (question 4, possible range 0-5, higher values indicate more bother).
Ejaculatory function [2 years after treatment initiation]
Assessed by the questionnaire Male Sexual Health Questionnaire-Ejaculation Dysfunction Short Form (MSHQ-EjD). Ejaculatory function total score (questions 1-3, possible range 0-15, higher values indicate better ejaculatory function, and MSHQ-EjD ejaculatory bother item (question 4, possible range 0-5, higher values indicate more bother).
Ejaculatory function [5 years after treatment initiation]
Assessed by the questionnaire Male Sexual Health Questionnaire-Ejaculation Dysfunction Short Form (MSHQ-EjD). Ejaculatory function total score (questions 1-3, possible range 0-15, higher values indicate better ejaculatory function, and MSHQ-EjD ejaculatory bother item (question 4, possible range 0-5, higher values indicate more bother).
Need for additional drug treatment, surgical treatment or change of medical treatment assessed [6 weeks after treatment initiation]
assessed by patient interviews at follow up visit
Need for additional drug treatment, surgical treatment or change of medical treatment assessed [6 moths after treatment initiation]
assessed by patient interviews at follow up visit
Need for additional drug treatment, surgical treatment or change of medical treatment assessed [1 year after treatment initiation]
assessed by patient interviews at follow up visit
Need for additional drug treatment, surgical treatment or change of medical treatment assessed [2 years after treatment initiation]
assessed by patient interviews at follow up visit
Need for additional drug treatment, surgical treatment or change of medical treatment assessed [5 years after treatment initiation]
assessed by patient interviews at follow up visit
Analysis of cost-effectiveness using quality-adjusted life years (QALY) [2 years after treatment initiation]
One QALY equates to one year in perfect health. QALY scores range from 1 (perfect health) to 0 (dead). To estimate QALY costs will be calculated by calculation of treatment costs, and quality of life will be assessed using the questionnaire EQ-5D. EQ-5D measures five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents self-rate their level of severity for each dimension using a five-level scale. The questionnaire can define 3,125 different health states.
Analysis of cost-effectiveness using quality-adjusted life years (QALY) [5 years after treatment initiation]
One QALY equates to one year in perfect health. QALY scores range from 1 (perfect health) to 0 (dead). To estimate QALY costs will be calculated by calculation of treatment costs, and quality of life will be assessed using the questionnaire EQ-5D. EQ-5D measures five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents self-rate their level of severity for each dimension using a five-level scale. The questionnaire can define 3,125 different health states.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 100 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

men ≥45 years of age
lower urinary tract symptoms assigned to BPH (diagnosis by medical history and physical examination)
IPSS ≥ 8 points
QoL ≥ 3 points
Qmax ≤ 15 ml/s with a minimum voided volume ≥ 125 ml
informed consent for study participation

Exclusion Criteria:

renal impairment (GFR < 30ml/min)
previous prostatic surgery
5-alpha reductase inhibitor (5-ARI) use within 6 mo (or dutasteride within 12 mo) prior to entry, or use of an α-blocker or phytotherapy for BPH within 2 weeks prior to entry
history or evidence of prostate cancer
absolute indication for surgical treatment of complications related to BPH (i.e. bladder stones, renal impairment due to bladder outlet obstruction)
history of neurogenic bladder dysfunction
not able to complete questionnaires due to cognitive or thought disorders
language skills insufficient for informed consent and / or completion of questionnaires

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Dominik Abt

Investigators

Principal Investigator: Dominik Abt, MD, Cantonal Hospital St. Gallen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dominik Abt, Principal Investigator, Consultant urologist, Cantonal Hospital of St. Gallen

ClinicalTrials.gov Identifier:

NCT04245566

Other Study ID Numbers:

CTU19/025

First Posted:

Jan 29, 2020

Last Update Posted:

Jan 26, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prostatic Hyperplasia

Hyperplasia

Study Results

No Results Posted as of Jan 26, 2021