Clinical trial NCT04245566: Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH
Official title: Prostatic Artery Embolization vs. Pharmacotherapy for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Pharmacotherapy
Prostatic Artery Embolization
Minimally Invasive Treatment
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 425
Sex: MALE
Minimum age (years): 45
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomized controlled study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: International Prostate Symptoms Score (IPSS)
timeFrame: 24 months after treatment initiation
Secondary outcomes:
measure: International Prostate Symptoms Score (IPSS)
timeFrame: 6 weeks after treatment initiation
measure: International Prostate Symptoms Score (IPSS)
timeFrame: 6 months after treatment initiation
measure: International Prostate Symptoms Score (IPSS)
timeFrame: 1 year after treatment initiation
measure: International Prostate Symptoms Score (IPSS)
timeFrame: 5 year after treatment initiation
measure: Self-assessed goal achievement (SAGA)
timeFrame: 6 weeks after treatment initiation
measure: Self-assessed goal achievement (SAGA)
timeFrame: 6 months after treatment initiation
measure: Self-assessed goal achievement (SAGA)
timeFrame: 1 year after treatment initiation
measure: Self-assessed goal achievement (SAGA)
timeFrame: 2 years after treatment initiation
measure: Self-assessed goal achievement (SAGA)
timeFrame: 5 years after treatment initiation
measure: Maximum urinary stream (Qmax)
timeFrame: 6 weeks after treatment initiation
measure: Maximum urinary stream (Qmax)
timeFrame: 6 months after treatment initiation
measure: Maximum urinary stream (Qmax)
timeFrame: 1 year after treatment initiation
measure: Maximum urinary stream (Qmax)
timeFrame: 2 years after treatment initiation
measure: Maximum urinary stream (Qmax)
timeFrame: 5 years after treatment initiation
measure: Post void residual urine (PVR)
timeFrame: 6 weeks after treatment initiation
measure: Post void residual urine (PVR)
timeFrame: 6 months after treatment initiation
measure: Post void residual urine (PVR)
timeFrame: 1 year after treatment initiation
measure: Post void residual urine (PVR)
timeFrame: 2 years after treatment initiation
measure: Post void residual urine (PVR)
timeFrame: 5 years after treatment initiation
measure: Prostate volume
timeFrame: 6 moths after treatment initiation
measure: Prostate volume
timeFrame: 2 years after treatment initiation
measure: Prostate volume
timeFrame: 5 years after treatment initiation
measure: Prostate specific antigen (PSA)
timeFrame: 6 months after treatment initiation
measure: Prostate specific antigen (PSA)
timeFrame: 1 year after treatment initiation
measure: Prostate specific antigen (PSA)
timeFrame: 2 years after treatment initiation
measure: Prostate specific antigen (PSA)
timeFrame: 5 years after treatment initiation
measure: Safety / adverse events
timeFrame: 6 weeks after treatment initiation
measure: Safety / adverse events
timeFrame: 6 months after treatment initiation
measure: Safety / adverse events
timeFrame: 1 year after treatment initiation
measure: Safety / adverse events
timeFrame: 2 year after treatment initiation
measure: Safety / adverse events
timeFrame: 5 year after treatment initiation
measure: Erectile function
timeFrame: 6 weeks after treatment initiation
measure: Erectile function
timeFrame: 6 months after treatment initiation
measure: Erectile function
timeFrame: 1 year after treatment initiation
measure: Erectile function
timeFrame: 2 year after treatment initiation
measure: Erectile function
timeFrame: 5 year after treatment initiation
measure: Ejaculatory function
timeFrame: 6 weeks after treatment initiation
measure: Ejaculatory function
timeFrame: 6 months after treatment initiation
measure: Ejaculatory function
timeFrame: 1 year after treatment initiation
measure: Ejaculatory function
timeFrame: 2 years after treatment initiation
measure: Ejaculatory function
timeFrame: 5 years after treatment initiation
measure: Need for additional drug treatment, surgical treatment or change of medical treatment assessed
timeFrame: 6 weeks after treatment initiation
measure: Need for additional drug treatment, surgical treatment or change of medical treatment assessed
timeFrame: 6 moths after treatment initiation
measure: Need for additional drug treatment, surgical treatment or change of medical treatment assessed
timeFrame: 1 year after treatment initiation
measure: Need for additional drug treatment, surgical treatment or change of medical treatment assessed
timeFrame: 2 years after treatment initiation
measure: Need for additional drug treatment, surgical treatment or change of medical treatment assessed
timeFrame: 5 years after treatment initiation
measure: Analysis of cost-effectiveness using quality-adjusted life years (QALY)
timeFrame: 2 years after treatment initiation
measure: Analysis of cost-effectiveness using quality-adjusted life years (QALY)
timeFrame: 5 years after treatment initiation
Other outcomes:
Locations:
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Dominik Abt, MD
role: PRINCIPAL_INVESTIGATOR
References: