A Phase II Randomized, Sham-Controlled, Double-Blind, Dose-Finding Study to Assess the Efficacy and Safety of Transurethral Photodynamic Therapy With Lemuteporfin in Subjects With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- QLT Inc.
- 入组人数
- 180
- 试验地点
- 18
- 主要终点
- The change from baseline in American Urological Association Symptom Index (AUA SI) score at the Month 3 visit
研究概览
简要总结
The purpose of this study is to determine if transurethral photodynamic therapy with lemuteporfin has a therapeutic effect on lower urinary tract symptoms due to an enlarged prostate.
Photodynamic therapy (known as "PDT") is a treatment that uses light to make a drug work. This means the drug is "light-activated". Light-activated drugs do not work until a certain color of light shines on the drug. When the drug and the light combine, they react together to destroy tissue.
This study is investigating PDT with lemuteporfin as a possible treatment for an enlarged prostate. PDT with lemuteporfin may destroy overgrown prostate tissue and help urinary symptoms go back to normal.
详细描述
This is a multi-center, randomized, sham-controlled, double-blind, dose-finding study in parallel groups of subjects with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). All subjects will receive a fixed dose of lemuteporfin injected transurethrally into the prostate followed by transurethral application of either one of three active light doses or a sham light dose. Subjects will be followed for safety and efficacy for a minimum of three months to a maximum of 12 months. The primary study endpoint will be the change from baseline in AUA SI score at three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men 21 years of age and older.
- •Subjects with LUTS due to BPH with AUA SI scores of 13 and over and Qmax between 5 and 15 mL/sec.
- •Subjects with urethral treatment length of at least 25 mm.
排除标准
- •Subjects who have had previous minimally invasive or surgical treatment for BPH.
- •Subjects who have unsuitable prostate dimensions.
结局指标
主要结局
The change from baseline in American Urological Association Symptom Index (AUA SI) score at the Month 3 visit
次要结局
- Responder rate
- Change from baseline in Qmax
- Change from baseline in post-void residual (PVR)
- Shifts from baseline in subject responses to the BPH Quality of Life Impact Assessment
- Safety outcomes: adverse events, clinical laboratory tests, vital signs, dysuria, and Male Sexual Health Questionnaire (MSHQ)