Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH

NCT ID: NCT04245566

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 425 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Prostatic Artery Embolization (PAE)

Intervention Type: PROCEDURE

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

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.

Group Type: PLACEBO_COMPARATOR

Pharmacotherapy

Intervention Type: DRUG

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

Interventions

Prostatic Artery Embolization (PAE)

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

Intervention Type: PROCEDURE

Pharmacotherapy

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Dominik Abt

OTHER

Sponsor Role: lead

Responsible Party

Dominik Abt

Principal Investigator, Consultant urologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dominik Abt, MD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital St. Gallen

Central Contacts

Dominik ABT, MD

Role: CONTACT

dominik.abt@kssg.ch

41714941418

Other Identifiers

CTU19/025

Identifier Type: -

Identifier Source: org_study_id