o A Prospective, Randomized, Open-Label, Phase II Study Evaluating the Efficacy of Tadalafil for the Prevention of Docetaxel-Induced Peripheral Neuropathy in Patients With Metastatic Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Incidence of Peripheral Neuropathy
研究概览
简要总结
Docetaxel is a standard chemotherapy for metastatic prostate cancer but is associated with dose-limiting peripheral neuropathy. Currently, no pharmacologic agents are established for prevention. Tadalafil, a PDE5 inhibitor, may improve microvascular perfusion and offer neuroprotection. This randomized phase II trial evaluates whether concurrent use of tadalafil (5 mg every 2 days) reduces the incidence and severity of docetaxel-induced peripheral neuropathy compared to standard care in patients with metastatic prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed prostate adenocarcinoma.
- •Metastatic hormone-sensitive (mHSPC) or castration-resistant prostate cancer (mCRPC).
- •Scheduled to receive docetaxel chemotherapy (50 mg/m^2 biweekly).
- •ECOG performance status 0-
- •Adequate bone marrow, hepatic, and renal function.
排除标准
- •Pre-existing peripheral neuropathy (CTCAE grade >= 1).
- •Prior treatment with taxane-based chemotherapy.
- •Concurrent use of nitrates or nitric oxide donors.
- •Severe cardiovascular disease (e.g., unstable angina, recent myocardial infarction within 6 months).
- •Known hypersensitivity to tadalafil or PDE5 inhibitors.
研究组 & 干预措施
Tadalafil Group (Experimental)
Patients receive Docetaxel chemotherapy plus Tadalafil.
干预措施: Tadalafil 5 mg (Drug)
Control Group (No Intervention)
Patients receive Docetaxel chemotherapy with standard supportive care alone.
结局指标
主要结局
Incidence of Peripheral Neuropathy
时间窗: From baseline up to the completion of 6 cycles of chemotherapy (approximately 12 weeks).
Defined as the proportion of patients developing sensory neuropathy Grade \> 1 according to NCI-CTCAE version 5.0 criteria.
次要结局
- Incidence of Moderate to Severe Neuropathy(Up to 12 weeks.)
- Patient-Reported Neuropathy Symptoms (EORTC QLQ-CIPN20)(Assessed at baseline and before each chemotherapy cycle (every 2 weeks) up to 12 weeks.)
- Oncological Efficacy (PSA Response)(Up to 12 weeks.)
研究者
MING-HSIN, YANG
DR.
Tri-Service General Hospital