A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression.
研究概览
简要总结
To determine whether, in this patient population, treatment with calcitriol and Naproxen is more effective in delaying the growth of prostate cancer than treatment with calcitriol alone as seen in historical controls.
详细描述
In summary, in vitro and in vivo studies, as well as early phase clinical trial, have shown a promising role for both calcitriol and NSAIDs in the treatment of prostate cancer. Moreover, calcitriol and NSAIDs both exert their antiproliferative effect by decreasing prostaglandin levels, but they do so by different mechanisms. Thus, there is reason to believe that their combined effects on prostaglandins may be synergistic. Preliminary in vitro assays in which calcitriol is given in combination with one of two different NSAIDs (Naprosyn or sulindac) to LNCaP cell lines have indicated such synergy. This observation provides the rational for using them in combination for the treatment of prostate cancer. In addition, it is hoped that any synergy noted would allow for the use of lower doses of NSAIDs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Must give written informed consent
- •Histologically confirmed adenocarcinoma of the prostate
- •Biochemical relapse after primary radiation therapy or surgery
- •Normal testosterone levels
- •3 rising PSA after nadir, with interval between PSA determinations > 2 weeks
排除标准
- •Local recurrence by CT scan
- •Distant metastases by bone scan
- •Hypercalcemia
- •Nephrolithiasis
- •Renal insufficiency (serum creatinine > 1.8 mg/dl)
- •Pancreatitis
- •History of ulcer or gastrointestinal bleeding
- •More than 6 months of hormone ablation therapy
- •Concurrent therapy for prostate cancer
- •Uncontrolled HTN
- •H/O MI, CVA, TIA
- •Known coronary disease/cerebrovascular disease
- •Platelet counts <50
- •Patients on anticoagulants
- •Patients on lithium
结局指标
主要结局
PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression.
次要结局
- Progressive disease in this study's patients, who would be treated with calcitriol and naprosyn, will be compared to that in historical controls of patients treated with calcitriol alone.
研究者
Sandy Srinivas
Associate Professor of Medicine
Stanford University