Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH (EMPATHY)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Benign Prostatic Hyperplasia; Pharmacotherapy; Prostatic Artery Embolization; Minimally Invasive Treatment
• Intervention / Treatment: Procedure: Prostatic Artery Embolization (PAE); Drug: Pharmacotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 425
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Dominik ABT, MD; Phone Number: 41714941418; Email: dominik.abt@kssg.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Prostate Symptoms Score (IPSS)	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.	24 months after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Prostate Symptoms Score (IPSS)	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.	6 weeks after treatment initiation
International Prostate Symptoms Score (IPSS)	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.	6 months after treatment initiation
International Prostate Symptoms Score (IPSS)	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.	1 year after treatment initiation
International Prostate Symptoms Score (IPSS)	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.	5 year after treatment initiation
Self-assessed goal achievement (SAGA)	SAGA is a PROM focusing on individual treatment goals SAGA is a patient reported outcome measure focusing on individual treatment goals	6 weeks after treatment initiation
Self-assessed goal achievement (SAGA)	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	6 months after treatment initiation
Self-assessed goal achievement (SAGA)	SAGA is a PROM focusing on individual treatment goals SAGA is a patient reported outcome measure focusing on individual treatment goals	1 year after treatment initiation
Self-assessed goal achievement (SAGA)	SAGA is a PROM focusing on individual treatment goals SAGA is a patient reported outcome measure focusing on individual treatment goals	2 years after treatment initiation
Self-assessed goal achievement (SAGA)	SAGA is a PROM focusing on individual treatment goals SAGA is a patient reported outcome measure focusing on individual treatment goals	5 years after treatment initiation
Maximum urinary stream (Qmax)	Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.	6 weeks after treatment initiation
Maximum urinary stream (Qmax)	Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.	6 months after treatment initiation
Maximum urinary stream (Qmax)	Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.	1 year after treatment initiation
Maximum urinary stream (Qmax)	Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.	2 years after treatment initiation
Maximum urinary stream (Qmax)	Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.	5 years after treatment initiation
Post void residual urine (PVR)	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.	6 weeks after treatment initiation
Post void residual urine (PVR)	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.	6 months after treatment initiation
Post void residual urine (PVR)	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.	1 year after treatment initiation
Post void residual urine (PVR)	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.	2 years after treatment initiation
Post void residual urine (PVR)	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.	5 years after treatment initiation
Prostate volume	Prostate volume measured by transrectal ultrasound. This examination is only performed at selected food-up visits (i.e. 6mo, 2y, 5y)	6 moths after treatment initiation
Prostate volume	Prostate volume measured by transrectal ultrasound. This examination is only performed at selected food-up visits (i.e. 6mo, 2y, 5y)	2 years after treatment initiation
Prostate volume	Prostate volume measured by transrectal ultrasound. This examination is only performed at selected food-up visits (i.e. 6mo, 2y, 5y)	5 years after treatment initiation
Prostate specific antigen (PSA)	laboratory test	6 months after treatment initiation
Prostate specific antigen (PSA)	laboratory test	1 year after treatment initiation
Prostate specific antigen (PSA)	laboratory test	2 years after treatment initiation
Prostate specific antigen (PSA)	laboratory test	5 years after treatment initiation
Safety / adverse events	Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.	6 weeks after treatment initiation
Safety / adverse events	Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.	6 months after treatment initiation
Safety / adverse events	Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.	1 year after treatment initiation
Safety / adverse events	Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.	2 year after treatment initiation
Safety / adverse events	Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.	5 year after treatment initiation
Erectile function	Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.	6 weeks after treatment initiation
Erectile function	Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.	6 months after treatment initiation
Erectile function	Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.	1 year after treatment initiation
Erectile function	Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.	2 year after treatment initiation
Erectile function	Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.	5 year after treatment initiation
Ejaculatory function	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).	6 weeks after treatment initiation
Ejaculatory function	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).	6 months after treatment initiation
Ejaculatory function	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).	1 year after treatment initiation
Ejaculatory function	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).	2 years after treatment initiation
Ejaculatory function	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).	5 years after treatment initiation
Need for additional drug treatment, surgical treatment or change of medical treatment assessed	assessed by patient interviews at follow up visit	6 weeks after treatment initiation
Need for additional drug treatment, surgical treatment or change of medical treatment assessed	assessed by patient interviews at follow up visit	6 moths after treatment initiation
Need for additional drug treatment, surgical treatment or change of medical treatment assessed	assessed by patient interviews at follow up visit	1 year after treatment initiation
Need for additional drug treatment, surgical treatment or change of medical treatment assessed	assessed by patient interviews at follow up visit	2 years after treatment initiation
Need for additional drug treatment, surgical treatment or change of medical treatment assessed	assessed by patient interviews at follow up visit	5 years after treatment initiation
Analysis of cost-effectiveness using quality-adjusted life years (QALY)	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.	2 years after treatment initiation
Analysis of cost-effectiveness using quality-adjusted life years (QALY)	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.	5 years after treatment initiation

Collaborators and Investigators

• Sponsor: Dominik Abt

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2025

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: January 25, 2020
• First Posted (ACTUAL): January 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: CTU19/025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

At the end of the study, data are stored in a publicly accessible repository (e.g.

Harvard Dataverse or Zenodo, depending on whether the data should be stored on a server in America or Europe). All elements are stored with a unique Digital Object Identifier (DOI), which can be referenced in the respective publication.

• IPD Sharing Time Frame: At the end of the study. Availability for at least 10 years.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

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