Phase 3 study compares aquablation with HoLEP in patients with BPH

The phase 3 ATHLETE noninferiority study has been launched comparing aquablation with holmium laser enucleation of the prostate (HoLEP) in the treatment of patients with benign prostatic hyperplasia (BPH).1

According to the researchers, aquablation has shown similar functional results in previous BPH studies when compared with the transurethral resection of the prostate (TURP) surgical technique, but there are no available data showing whether aquablation is noninferior to the well-established HoLEP technique.

The prospective, noninferiority, open-label ATHLETE trial is a single-center study being conducted at a Swiss center of tertiary care. Patients will be evenly randomized to either aquablation or HoLEP using the secuTrial software system. Both procedures will be performed in an inpatient setting. Stratification will be by age (<70 years or ≥70 years) and prostate volume (<100 mL or ≥100 mL). Routine follow-up controls will commence 8 weeks following the procedure and will continue for up to 5 years.

The target enrollment for the trial is 120 patients. The age requirement is ≥45 years. To enroll, patients must be eligible for HoLEP; refractory to medical therapy or not willing to consider other medical treatment; and have a prostate size between 50 ml and 150 ml as determined by transrectal ultrasound (TRUS).Patients must also have a baseline International Prostate Symptom Score (IPSS) ≥12, QoL ≥3, and Qmax ≤15 ml/s with a minimum voided volume ≥ 125 ml or be in urinary retention.

Exclusion criteria for the study consist of the following: neurogenic lower urinary tract dysfunction, urethral stenosis, pre-interventionally proven adenocarcinoma of the prostate, nickel allergy, cognitive or thought disorders that make patients unable to complete questionnaires, and insufficient language skills for informed consent and/or completion of questionnaires.

The primary outcome measure of the study is evaluating the noninferiority of aquablation versus HoLEP in alleviating lower urinary tract symptoms (LUTS) related to benign prostatic obstruction as measured by the IPSS at 6 months. The estimated primary completion date is April 2023.

Prior aquablation data

Previously published study results showed noninferiority between aquablation and TURP after 3 years of follow-up in patients with LUTS related to BPH.2 The 3-year data showed that aquablation and TURP led to similar outcomes in BPH symptom reduction and urinary flow rate improvement.

The blinded trial randomized patients to either aquablation or HoLEP. The mean improvement in IPSS scores was similar across the 2 treatment arms at 14.4 points with aquablation versus 13.9 points with HoLEP. Similarly, 3-year Qmax improvements were 11.6 versus 8.2 cc/sec, respectively. Further, surgical retreatment for BPH beyond 20 months was not required by any patients in either the aquablation or TURP arms.

References

1. NIH US National Library of Medicine ClinicalTrials.gov. Aquablation vs. Holmium Laser Enucleation of the Prostate in the Treatment of Benign Prostatic Hyperplasia in Medium to Large Size Prostates (ATHLETE). Last updated January 8, 2021. https://clinicaltrials.gov/ct2/show/NCT04560907

2. Gilling P, Barber N, Bidair M, et al. Three-year outcomes after Aquablation therapy compared to TURP: results from a blinded randomized trial. Can J Urol. 2020;27(1):10072-10079.