Trial reportThe Journal of urology2013
Prospective, randomized, double-blind, vehicle controlled, multicenter phase IIb clinical trial of the pore forming protein PRX302 for targeted treatment of symptomatic benign prostatic hyperplasia.
Trial report in The Journal of urology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed.
- Evaluating the Impact of Benign Prostatic Hyperplasia Surgical Treatments on Sexual Health.Biomedicines · 2024Review
- Remodelling of the tumour microenvironment by the kallikrein-related peptidases.Nature reviews. Cancer · 2022Review
- [Minimally invasive treatment options for the management of benign prostatic hyperplasia].Der Urologe. Ausg. A · 2021Article
- New Ultra-minimally Invasive Surgical Treatment for Benign Prostatic Hyperplasia: A Systematic Review and Analysis of Comparative Outcomes.European urology open science · 2021Review
- iTIND for BPH: Technique and procedural outcomes: A narrative review of current literature.Turkish journal of urology · 2021Article
- Review
- A state-of-art review on the preservation of sexual function among various minimally invasive surgical treatments for benign prostatic hyperplasia: Impact on erectile and ejaculatory domains.Investigative and clinical urology · 2021Review
- Microparticle Encapsulation of a Prostate-targeted Biologic for the Treatment of Liver Metastases in a Preclinical Model of Castration-resistant Prostate Cancer.Molecular cancer therapeutics · 2020Article
- Transperineal laser ablation for percutaneous treatment of benign prostatic hyperplasia: a feasibility study. Results at 6 and 12 months from a retrospective multi-centric study.Prostate cancer and prostatic diseases · 2020Article
- Minimizing Sexual Dysfunction in BPH Surgery.Current sexual health reports · 2019Article
- Comparing Outcomes of Medical Management and Minimally Invasive Surgical Techniques for Lower Urinary Tract Symptoms due to BPH.Current urology reports · 2019Review
- [Novel minimally invasive treatment options for male lower urinary tract symptom].Der Urologe. Ausg. A · 2019Review
- Mesenchymal stem cells and the embryonic reawakening theory of BPH.Nature reviews. Urology · 2018Review
- PSA-selective activation of cytotoxic human serine proteases within the tumor microenvironment as a therapeutic strategy to target prostate cancer.Oncotarget · 2018Article
- Expected Next-Generation Drugs Under Development in Relation to Voiding Symptoms.International neurourology journal · 2017Review
- Minimally invasive surgical therapies for benign prostatic hypertrophy: The rise in minimally invasive surgical therapies.Prostate international · 2017Review
- Apoptotic Pathways Linked to Endocrine System as Potential Therapeutic Targets for Benign Prostatic Hyperplasia.International journal of molecular sciences · 2016Review
- The Effect of LUTS/BPH and Treatments on Ejaculatory Function.Current urology reports · 2016Review
- A prodrug-doped cellular Trojan Horse for the potential treatment of prostate cancer.Biomaterials · 2016Article
- Placebo Medication and Sham Surgery Responses in Benign Prostatic Hyperplasia Treatments: Implications for Clinical Trials.Current urology reports · 2015Review
Corrections and comments
- Commented on by
Authors and funding
6 authors.
Funding
Abstract
purposeWe conducted a safety and efficacy evaluation of intraprostatic injection of PRX302, a modified pore forming protein (proaerolysin) activated by prostate specific antigen, as a highly targeted, localized approach to treat lower urinary tract symptoms due to benign prostatic hyperplasia. MATERIALS AND
methodsA total of 92 patients with I-PSS (International Prostate Symptom Score) 15 or greater, peak urine flow 12 ml or less per second and prostate volume 30 to 100 ml were randomized 2:1 to a single ultrasound guided intraprostatic injection of PRX302 vs vehicle (placebo) in this phase IIb double-blind study. Injection was 20% of prostate volume and 0.6 μg PRX302 per gm prostate. Peak urine flow was determined by a blinded reviewer. Benign prostatic hyperplasia medications were prohibited. The primary data set of efficacy evaluable patients (73) was analyzed using last observation carried forward.
resultsPRX302 treatment resulted in an approximate 9-point reduction in I-PSS and 3 ml per second increase in peak urine flow that were statistically significant changes from baseline compared to vehicle. Efficacy was sustained for 12 months. Early withdrawal for other benign prostatic hyperplasia treatment was more common for patients in the vehicle group. Relative to vehicle, PRX302 apparent toxicity was mild, transient, and limited to local discomfort/pain and irritative urinary symptoms occurring in the first few days, with no effect on erectile function.
conclusionsA single administration of PRX302 as a short, outpatient based procedure was well tolerated in patients with lower urinary tract symptoms due to benign prostatic hyperplasia. PRX302 produced clinically meaningful and statistically significant improvement in patient subjective (I-PSS) and quantitative objective (peak urine flow) measures sustained for 12 months. The side effect profile is favorable with most effects attributed to the injection itself and not related to drug toxicity.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.