Lb-s&t-06 Novel Dual-binding Selective Degraders of Full Length and Splice Variant Androgen Receptors for the Treatment of Castration-resistant Prostate Cancer
Year: 2016
Type: article
Study design: Clinical Trial
Abstract: and lack of sustainability, and more invasive surgical interventions, which also have side effects and complications.PRX302 (topsalysin) is a genetically modified pore-forming protein (aerolysin) activated intraprostatically only by enzymatically active PSA, and thus a specific, highlytargeted, localized approach to lysing cells in the prostate transition zone.METHODS: 479 patients from 75 sites in 6 countries with International Prostate Symptom Score (IPSS) >¼15, peak urine flow (Qmax) 5-15 mL/s, and prostate volume (PV) 30-100 mL were randomized 1:1 to a single transrectal intraprostatic injection of PRX302 vs. placebo (vehicle) and then monitored for 52 weeks.BPH medications were washed out and prohibited on study.Injection was 20% of PV and 0.6 ug PRX302/g PV.RESULTS: 92% of patients completed all 52 weeks.A single administration of PRX302 provided 7.6 points mean improvement in LUTS that was statistically significantly superior to vehicle-only injection, sustained through the Week 52 end of monitoring.This IPSS primary endpoint efficacy was supported by secondary endpoints, including positive findings for Qmax and two patient-rated diseasespecific quality of life instruments.Relative to vehicle, PRX302apparent toxicity was in general mild, transient, limited to irritative urinary symptoms (dysuria 20%, pollakiuria 10%, urinary retention 4%), local discomfort/pain (perineal pain 9%), and general constitutional symptoms (fever 8%, chills 2%), occurring primarily on the day of injection, with no adverse effect on sexual function.CONCLUSIONS: A single intraprostatic administration of PRX302 as a short, office-based procedure was well tolerated and produced clinically meaningful and sustained improvement in BPH LUTS over the 52 weeks of follow-up.Additional studies are planned.
Source: The Journal of Urology
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2328061997