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.
Vermeulen et al. (Thu,) studied this question.