Enrollment goal met in trial of Urocross Expander Implant for BPH-related LUTS

The target enrollment has been met in the pivotal Expander-2 trial (NCT05400980) of the Urocross Expander System and Retrieval Sheath in patients with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia, Prodeon Medical announced in a news release.¹

Final completion of the study is anticipated for September 2028.

According to the company, the Urocross Expander System is an investigational minimally invasive, non-permanent implantable nitinol tissue expander for patients with BPH-related LUTS. The Expander-2 trial is intended to provide data that will support submission of the device for regulatory approval.

“The removable design of the Urocross Expander as a non-permanent prostatic implant creates a new paradigm for the treatment of men with BPH who want to avoid tissue resection and sexual dysfunction,” said co-principal investigator Daniel B. Rukstalis, MD, the vice chair of research and professor at Virginia Tech Carilion School of Medicine, Roanoke, Virginia, in the news release.¹ “The fact that this system works without cutting, burning, ablating, or leaving a permanent foreign body inside the prostate is truly revolutionary. It opens up a whole new world of possibilities for how we approach treatment, offering patients effective relief with minimal intervention.”

In total, the multicenter, double blinded, randomized controlled study planned to enroll 240 adult patients to study the safety and efficacy of the Urocross Expander System and Retrieval Sheath in patients with symptomatic BPH.² Participants were enrolled across clinical trial sites in the US and Canada.

To be eligible for enrollment in the trial, patients needed to be 45 years or older and have symptomatic BPH with an International Prostate Symptom Score (IPSS) score of 13 or higher, a Qmax of 12 mL/sec or lower on a voided volume of at least 125 mL, and a post-void residual (PVR) less than 250 mL. Additionally, patients needed to have a prostate volume of 30 to 80 cc per transrectal ultrasound or MRI within 6 months of study start.

Those included in the study will be randomly assigned 2:1 to receive the Urocross Expander Implant inserted via delivery catheter or to the sham arm, consisting of cystoscopy only. Patients will be blinded up until 3 months post-procedure, marking the time of assessment of the primary efficacy end point.

The primary safety end point is the rate of extended urinary catheterization (more than 7 days) following the procedure. The primary efficacy end point is the change in total IPSS from baseline to 3 months following the procedure. The study will also assess the percent change in total IPSS from baseline to 3 months post-procedure as a secondary efficacy end point.

Final completion of the study is anticipated for September 2028.

“We are excited to reach this important milestone in the Expander-2 pivotal trial,” said Paul Edwards, president and CEO of Prodeon Medical, in the news release.¹ “Completing enrollment is a key step in our mission to advance innovative treatments for BPH that improve patient outcomes and quality of life. We are thankful to our patients, investigators, and research teams for their participation and dedication to our study.”

Data on the Urocross Expander Implant

The Expander-2 trial builds on promising findings from the first-in-human Expander-1 trial (NCT03758222), which were published in Prostate Cancer and Prostatic Diseases in May 2022.³

Overall, data from the trial showed that the PRostatic Urethral Expansion (PURE) procedure with the Urocross Expander System (formerly XFLO Expander System) was safe and feasible in patients with BPH-related LUTS. At the time of data report, 39 men had implants successfully deployed, and 22 had implants successfully retrieved with no complications.

Adverse events (AEs) related to the device or procedure were generally mild to moderate in severity. In total, 3 serious AEs were observed, 2 of which were related to the device and/or procedure. No instances of implant encrustation were reported.

Interim efficacy data also showed improvements in IPSS, quality of life, PVR, Qmax, and sexual function.

The authors concluded, “To date, the Expander System provides a signal of efficacy similar to that observed in other early-stage [minimally invasive surgical therapy] trials. This, in addition to a favorable safety profile, justifies further evaluation of a PURE approach for treating BPH/LUTS. These results also suggest that the negative features of earlier generations of prostatic stents such as biocompatibility, migrations, and encrustation have been overcome.”

References

1. Prodeon Medical announces enrollment completion for Expander-2 pivotal trial. News release. Prodeon Medical. Published online and accessed January 13, 2025. https://www.globenewswire.com/news-release/2025/01/13/3008413/0/en/Prodeon-Medical-Announces-Enrollment-Completion-for-Expander-2-Pivotal-Trial.html

2. Expander-2 trial: Randomized study to evaluate safety & efficacy of the Urocross(TM) Expander System & Retrieval Sheath. ClinicalTrials.gov. Last updated July 3, 2024. Accessed January 13, 2025. https://clinicaltrials.gov/study/NCT05400980

3. Woo HH, Huang CP, Huang WJ, et al. The EXPANDER-1 trial: introduction of the novel Urocross Expander System for treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Prostate Cancer Prostatic Dis. 2022;25(3):576-582. doi:10.1038/s41391-022-00548-z