Prostatic artery embolisation versus medical treatment in patients with benign prostatic hyperplasia (PARTEM): a randomised, multicentre, open-label, phase 3, superiority trial

Abstract

Background: Prostatic artery embolisation (PAE) is a minimally invasive treatment of symptomatic benign prostatic hyperplasia (BPH). Our aim was to compare patient's symptoms improvement after PAE and medical treatment.

Methods: A randomised, open-label, superiority trial was set in 10 French hospitals. Patients with bothersome lower urinary tract symptoms (LUTS) defined by International Prostatic Symptom Score (IPSS) > 11 and quality of life (QoL) > 3, and BPH ≥50 ml resistant to alpha-blocker monotherapy were randomly assigned (1:1) to PAE or Combined Therapy ([CT], oral dutasteride 0.5 mg/tamsulosin hydrochloride 0.4 mg per day). Randomisation was stratified by centre, IPSS and prostate volume with a minimisation procedure. The primary outcome was the 9-month IPSS change. Primary and safety analysis were done according to the intention-to-treat (ITT) principle among patients with an evaluable primary outcome. ClinicalTrials.gov Identifier: NCT02869971.

Findings: Ninety patients were randomised from September 2016 to February 2020, and 44 and 43 patients assessed for primary endpoint in PAE and CT groups, respectively. The 9-month change of IPSS was -10.0 (95% confidence interval [CI]: -11.8 to -8.3) and -5.7 (95% CI: -7.5 to -3.8) in the PAE and CT groups, respectively. This reduction was significantly greater in the PAE group than in the CT group (-4.4 [95% CI: -6.9 to -1.9], p = 0.0008). The IIEF-15 score change was 8.2 (95% CI: 2.9-13.5) and -2.8 (95% CI: -8.4 to 2.8) in the PAE and CT groups, respectively. No treatment-related AE or hospitalisation was noticed. After 9 months, 5 and 18 patients had invasive prostate re-treatment in the PAE and CT group, respectively.

Interpretation: In patients with BPH ≥50 ml and bothersome LUTS resistant to alpha-blocker monotherapy, PAE provides more urinary and sexual symptoms benefit than CT up to 24 months.

Funding: French Ministry of Health and a complementary grant from Merit Medical.

Keywords: 5- alpha-reductase inhibitors; Alpha-blockers; Benign prostatic hyperplasia; Cost; Economics; Erectile function; International prostatic symptom score; Lower urinary tract symptoms; Prostatic artery embolisation.

Fig. 1

Study flow-chart. ∗ One patient was also non adherent to the combined therapy (Tamsulosin and Dutasteride in a combined pill). † Two patients were also non adherent to the combined therapy (Tamsulosin and Dutasteride in a combined pill). PAE denotes prostatic artery embolisation, CT combined therapy, IPSS International Prostatic Symptom Score and BPH benign prostatic hyperplasia.

Fig. 2

Between-subject variability: between-subject variability in IPSS∗ (Panel a) and IIEF-15 (Panel b) score changes from baseline to 9 months in the prostatic artery embolisation and the combined therapy group (modified intention-to-treat population). ∗ The dashed line corresponds to the clinically relevant improvement of IPSS. IPSS, Denotes international prostatic symptom score and IIEF, International index of erectile function. Symptoms are improved when IPSS is decreased and when IIEF score is increased.