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

Dominik Abt

Status and phase: Not yet enrolling; Phase 3

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

Treatments: Drug: Pharmacotherapy; Procedure: Prostatic Artery Embolization (PAE)

Study type: Interventional

Funder types: Other

Identifiers

NCT04245566

CTU19/025

Details and patient eligibility

About

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.

Enrollment: 425 estimated patients

Sex: Male

Ages: 45 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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425 participants in 2 patient groups, including a placebo group

Prostatic Artery Embolization (PAE)

Experimental group

Description:

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.

Treatment:

Procedure: Prostatic Artery Embolization (PAE)

Pharmocotherapy

Placebo Comparator group

Description:

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.

Treatment:

Drug: Pharmacotherapy