NCT00316927已完成3 期
A Randomized Phase III Trial of Dexamethasone and Aspirin (DA) Versus Dexamethasone, Diethylstilbestrol and Aspirin (DAS) in Locally Advanced or Metastatic Cancer of the Prostate - Immediate Versus Deferred Diethylstilbestrol
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 30
- 主要终点
- Prostate-specific antigen (PSA) response
研究概览
简要总结
RATIONALE: Giving dexamethasone together with aspirin and diethylstilbestrol may be effective in lowering prostate-specific antigen levels and may slow or stop the growth of prostate cancer. It is not yet known which schedule of dexamethasone, aspirin, and diethylstilbestrol is more effective in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying dexamethasone and aspirin when given together with two different schedules of diethylstilbestrol to compare how well they work in treating patients with locally advanced or metastatic prostate cancer.
详细描述
OBJECTIVES:
Primary
- Compare the prostate-specific antigen (PSA) response in patients with locally advanced or metastatic prostate cancer treated with dexamethasone and aspirin with delayed vs immediate diethylstilbestrol.
Secondary
- Compare the overall response rate in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the progression-free and overall survival of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of adenocarcinoma of the prostate
- •Elevated prostate-specific antigen (PSA)
- •Failed previous treatments, including gonadatropan regulatory hormone analogue therapy, radiotherapy, surgery, or any combination of these
- •Biochemically castrate (testosterone < 1 nmol/L) at baseline
- •PATIENT CHARACTERISTICS:
- •Life expectancy ≥ 3 months
- •ECOG performance status 0-3
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count (neutrophils and bands) ≥ 2,000/mm^3
- •Platelet count ≥ 50,000/mm^3
- •Bilirubin ≤ 2 times upper limit of normal (ULN)
- •AST or ALT ≤ 3 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Able to swallow tablets
- •No other malignancy within the past 3 years except basal cell skin cancer
- •No previous thromboembolic disease, including stroke, venous or arterial thrombosis, and myocardial infarction with ongoing angina pectoris
- •Prior uncomplicated myocardial infarction allowed
- •No diabetes mellitus if treatment titration is thought to be difficult or inappropriate
- •No active gastric or duodenal ulcer
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Prior concurrent bisphosphonates allowed
- •No concurrent investigational agents or participation in another investigational drug study
- •No other concurrent antineoplastic therapy, including new estrogen therapy, radiation therapy, or PC-SPES
- •No other concurrent corticosteroids (e.g., dexamethasone for nausea or vomiting) except those prescribed in the study regimen
排除标准
- 未提供
结局指标
主要结局
Prostate-specific antigen (PSA) response
次要结局
- Overall response
- Quality of life
- Progression-free and overall survival
研究者
研究点 (30)
Loading locations...
相似试验
已完成
3 期
Phase III Randomized, Double-Blind Study of Dexamethasone Vs Dexamethasone/Methylprednisolone Vs Placebo for Bronchopulmonary DysplasiaBronchopulmonary DysplasiaNCT00004785National Center for Research Resources (NCRR)54
尚未招募
不适用
The effectiveness of dexamethasone as an adjunct to surgery on satisfactory resolution of chronic subdural haematomas: A randomised control trialNervous System DiseasesSurgeryChronic subdural haematomasPACTR201406000799322Research Support Unit, Aga Khan University Nairobi50
尚未招募
2 期
A clinical trial to compare two different drug schedules used for prevention of post-operative nausea and vomiting in patients undergoing total abdominal hysterectomyCTRI/2023/08/056041Prashant Dhatwalia
尚未招募
1 期
Dexamethasone and Azeliragon for Management of Post-Resection Cerebral Edema in Patients With GlioblastomaMalignant GliomaGlioblastomaNCT05773664City of Hope Medical Center21
Unknown
不适用
Oral Aprepitant and Lower Dose Dexamethasone Versus Aprepitant Alone for Preventing Postoperative Nausea and Vomiting (PONV) After Elective Laparoscopic SurgeriesNauseaVomitingNCT00835965Main Line Health50