A first-in-human study of paclitaxel eluting bioabsorbable implants for the treatment of BPH symptoms

Lodewikus P. Vermeulen^1,*, Flavio V. Ordones¹, Peter J. Gilling¹, Homi Zargar², James Symons³, Janelle Brennan⁴, Shahram S. Gholami⁵
1 Department of Urology, Tauranga Hospital, Tauranga, New Zealand
2 Western Urology, Melbourne, Australia
3 Sydney Adventist Hospital, Sydney, Australia
4 Goldfields Urology, Bendigo, Australia
5 Resurge Therapeutics, San Jose, CA, USA
* Corresponding Author: Lodewikus P. Vermeulen. Email: email , email
(This article belongs to the Special Issue: Recent Advances in Urology: Innovations Across the Spectrum of Care)

Canadian Journal of Urology https://doi.org/10.32604/cju.2026.078938

Received 15 February 2026; Accepted 07 May 2026; Published online 18 June 2026

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Abstract

Backgrounds: Paclitaxel-eluting bioabsorbable im-plants are a novel office-based intraprostatic drug elution (IPDE) therapy for men suffering from lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). The objective of this study is to evaluate the safety and feasibility of IPDE in a dose escalation clinical trial. Methods: We report the initial low-dose cohort results from a first-in-human dose escalation study across four sites in Australia and New Zealand (NCT06136819). IPDE therapy of the first five participants was performed, each patient received a one-time dosing of 4–6 bioabsorbable implants in the initial low-dose cohort. Results: IPSS improved by 11 points from baseline, 30 days after treatment, with 80% of patients showing improvement of symptoms and this improvement was sustained for at least 180 days. Post-procedure pain was minimal, adverse events were mild, and no serious drug or procedure-related adverse events have been reported to date. Additional treatments at current and higher doses are ongoing in up to 20 participants. Conclusions: Treatment of BPH symptoms secondary to BPH using paclitaxel-eluting bioabsorbable implants appears safe and feasible. Initial results are promising with patients reporting symptom relief and minimal side effects.