Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH

NCT04245566 | Unknown Phase 3 DMC

• 1 other identifier: CTU19/025
• Study Type: interventional
• Target: 425
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Benign Prostatic Hyperplasia; Pharmacotherapy; Prostatic Artery Embolization; Minimally Invasive Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (48)

• International Prostate Symptoms Score (IPSS)

  6 weeks after treatment initiation

• International Prostate Symptoms Score (IPSS)

  6 months after treatment initiation

• International Prostate Symptoms Score (IPSS)

  1 year after treatment initiation

• International Prostate Symptoms Score (IPSS)

  5 year after treatment initiation

• Self-assessed goal achievement (SAGA)

  6 weeks after treatment initiation

Study Arms (2)

Prostatic Artery Embolization (PAE)

EXPERIMENTAL

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)

Pharmocotherapy

PLACEBO COMPARATOR

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

Interventions

Prostatic Artery Embolization (PAE) PROCEDURE

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

Prostatic Artery Embolization (PAE)

Pharmacotherapy DRUG

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

Pharmocotherapy

Eligibility Criteria

• Age: 45 Years - 100 Years
• Gender Eligibility Details: based on presence of a prostate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• renal impairment (GFR \< 30ml/min)
• previous prostatic surgery
• 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

Sponsors & Collaborators

• Dominik Abt: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Dominik Abt, MD

  Cantonal Hospital of St. Gallen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominik ABT, MD

CONTACT

41714941418; dominik.abt@kssg.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Consultant urologist

Model Details: 1:1 randomized controlled study

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 29, 2020
• Study Start: September 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2025
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: At the end of the study. Availability for at least 10 years.