Intraprostatic drug elution therapy shows promise for BPH-related LUTS

Paclitaxel eluting bioabsorbable implants demonstrated encouraging efficacy and appeared to be safe and feasible in the management of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), according to 6-month data from a phase 1 first-in-human study (NCT06136819).¹

The phase 1 dose escalation trial plans to enroll 20 patients.

The bioabsorbable implants are a novel office-based, minimally invasive form of intraprostatic drug elution (IPDE) therapy. Findings on this investigational therapy were presented at the American Urological Association (AUA) 2025 Annual Meeting in Las Vegas, Nevada.

"In the US alone, an estimated 40 million men are affected by BPH, with 8 million currently on daily medications—many of whom are unsatisfied with current treatment options," said Shahram Gholami, MD, co-founder of Resurge Therapeutics, in a news release from the company.² "Our early clinical results suggest the novel IPDE therapy has the potential to offer durable symptom relief in a single treatment, without the side effects of either oral drugs or surgical procedures and also without the adherence challenges of daily medications.

At the time of data report, the study had dosed 5 patients with a single administration of initial IPDE via transperineal implantation, with each patient receiving 4 to 6 bioabsorbable implants during the procedure. The mean age of participants was 63 years.

Data showed that post-treatment pain levels were minimal, with a score via visual analogue scale of 0.9 at 1 day following the procedure and 0.0 at 7 days following the procedure. At discharge, pain levels were also 0.0. There were no instances of post-procedure catheterization.

Treatment also demonstrated promising efficacy, with 80% of patients showing an improvement in symptoms. Data showed an 11-point decrease in International Prostate Symptom Score (IPSS) from baseline to 90 days following treatment. Additionally, there was an average improvement of 5 mL/sec in maximum urinary flow rate.

There have been no serious drug- or procedure-related adverse events (AEs) reported to date. Observed AEs were generally mild and resolved within 7 days or less from treatment, according to the authors.

In total, the phase 1 dose escalation trial plans to enroll 20 patients across 4 clinical trial sites in Australia and New Zealand.³

To be eligible for enrollment, patients need to be aged 50 years or older and have an IPSS of at least 13, a peak urine flow rate between 5 mL/sec and 15 mL/sec, a voided volume of at least 100 mL, a post-void residual urine volume of at least 250 mL, a prostate volume between 25 cc and 100 cc, and an inadequate response and/or refusal of medical therapy for LUTS.

The primary outcome measure is the absence of unanticipated AEs or serious AEs, measured from baseline to day 180. Secondary outcome measures include the change in prostate volume, change in IPSS, post-void residual, peak flow rate, average flow rate, and voided volume, all measured through 180 days.

Overall, the phase 1 study is ongoing, with final completion expected in June 2025.

The authors noted, “Further follow-up to 180 days and additional treatments at current and higher doses are ongoing in the first 20 patients.”

Resurge Therapeutics also announced plans to collaborate with the FDA to advance the IPDE therapy through further clinical studies and ultimately to market approval.

REFERENCES

1. Vermeulen LP, Ordones FV, Gilling PJ, et al. A first in human safety and feasibility study of intraprostatic drug eluting bioabsorbable implants for treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol. 2025;213(5S):e987. doi:10.1097/01.JU.0001110064.72214.9d.10

2. Resurge Therapeutics announces compelling six-month clinical results from novel prostate drug delivery therapy. News release. Resurge Therapeutics. May 27, 2025. Accessed May 29, 2025. https://www.prnewswire.com/news-releases/resurge-therapeutics-announces-compelling-six-month-clinical-results-from-novel-prostate-drug-delivery-therapy-302464645.html

3. RT-310 dose escalation BPH study. ClinicalTrials.gov. Last updated November 13, 2024. Accessed May 29, 2025. https://clinicaltrials.gov/study/NCT06136819