Prostatic Urethral Lift (PUL) Pre-/Post-Radiation Treatment for Prostate Cancer: Prospective Analysis of Outcomes in Patients With Obstructive Urinary Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Mean change in International Prostate Symptom Score (IPSS) - Arms: PUL placement post-EBRT and PUL placement post-BT
研究概览
简要总结
The purpose of this study is to test the use of the Prostatic Urethral Lift (PUL), Urolift®, in prostate cancer (Pca) participants seeking or undergoing radiotherapy for relief of urinary obstructive symptoms.
详细描述
Prostatic Urethral Lift (PUL)/ UroLift® is an FDA-approved device for the treatment of obstructive symptoms due to benign prostatic hyperplasia (BPH) (also called prostate gland enlargement). This study seeks to evaluate UroLift's efficacy in a unique cohort of participants with obstructive symptoms who are candidates for radiotherapy or those who developed obstructive symptoms after radiotherapy. The primary objective of this study is to achieve urinary obstructive symptom relief in prostate cancer participants undergoing radiotherapy treatment with placement of PUL. This will be quantified using primary effectiveness endpoints:
- For PUL placement post-EBRT and post-BT: ≥ 30% or ≥ 4 point International Prostate Symptom Score (IPSS) reduction 3 months after PUL.
- For PUL placement pre-BT: ≥ 30% or ≥ 4 point IPSS reduction 3 months after Brachytherapy (BT) from pre-PUL baseline.
The team will also assess participant outcomes with regard to International Prostate Symptom Score (IPSS), peak urine flow (Qmax),post-void residual (PVR), quality of life (QOL) scores, Benign Prostatic Hyperplasia Impact Index (BPHII) scores, Men's Sexual Health Questionnaire (MSHQ) scores, and urinary incontinence at 6 and 12 months of PUL placement post-External Beam Radiotherapy (EBRT), post-BT, and pre-BT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 51 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •International Prostate Symptom Score ≥
- •Peak flow rate ≤ 12 ml/sec with at least 125 ml voided urine.
- •Prostate volume ≤ 80 cc as measured either by trans-rectal ultrasound (US) or Magnetic Resonance Imaging (MRI).
排除标准
- •Obstructive median lobe of the prostate.
- •Active urinary tract infection.
- •Neurogenic non-obstructive voiding dysfunction.
- •Obstructive symptoms secondary to prostate cancer (via cystoscopy).
- •Patients with prior Transurethral resection of the prostate (TURP).
- •Patients with prior history of urethral stricture.
研究组 & 干预措施
Prostatic Urethral Lift (PUL) post-EBRT
Prostatic Urethral Lift (PUL) following External Beam Radiotherapy (EBRT)
干预措施: Prostatic Urethral Lift (PUL) (Device)
Prostatic Urethral Lift (PUL) pre-BT
Prostatic Urethral Lift (PUL) preceding Brachytherapy (BT)
干预措施: Prostatic Urethral Lift (PUL) (Device)
Prostatic Urethral Lift (PUL) post-BT
Prostatic Urethral Lift (PUL) following Brachytherapy (BT)
干预措施: Prostatic Urethral Lift (PUL) (Device)
结局指标
主要结局
Mean change in International Prostate Symptom Score (IPSS) - Arms: PUL placement post-EBRT and PUL placement post-BT
时间窗: 3 months post-PUL placement
IPSS is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia. A mean change in International Prostate Symptom Score (IPSS) will be considered effective if the following condition is met: ≥ 30% or ≥ 4 point IPSS reduction 3 months after PUL.
Mean change in International Prostate Symptom Score (IPSS) - Arm: PUL placement pre-BT.
时间窗: 3 months post-BT
IPSS is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia. A mean change in International Prostate Symptom Score (IPSS) will be considered effective if the following condition is met: * 30% or ≥ 4 point IPSS reduction 3 months after BT from pre-PUL baseline.
次要结局
- Quality of life scores from last question on IPSS questionnaire(6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms))
- Mean change in International Prostate Symptom Score (IPSS)(6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms))
- Mean change in peak urinary flow rate (Qmax)(6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms))
- Mean change in Benign Prostatic Hyperplasia Impact Index (BPHII) scores(6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms))
- Mean change in the MSHQ total score(6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms))
- Urinary incontinence measured by number of pads used(6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms))
- Urinary incontinence measured by quality of stress or urge(6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms))
- Urinary incontinence measured by cough stress test(6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms))
- Urinary incontinence measured by time to resolve(6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms))
- Mean change in post-void residual (PVR)(3, 6, and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)