A Pilot Trial of Calcitriol in Localized Prostate Cancer: Investigation of Biologic Effects and Potential Intermediate Endpoints
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Effect of Preoperative High-dose Calcitriol and Dexamethasone on Prostatic Tumor Vessel Density Measured at 1, 2, 3, and 12 Months Post Prostatectomy
研究概览
简要总结
RATIONALE: Calcitriol and dexamethasone may slow the growth of prostate cancer cells.
PURPOSE: This randomized phase II trial is studying how well giving calcitriol together with dexamethasone before radical prostatectomy works in treating patients with localized stage II or stage III adenocarcinoma (cancer) of the prostate.
详细描述
OBJECTIVES:
- Determine the effect of calcitriol and dexamethasone before radical prostatectomy on tumor vessel density in patients with localized adenocarcinoma of the prostate.
- Determine the effect of this regimen on the extent of prostatic intraepithelial neoplasia in these patients.
- Determine the effect of this regimen on the expression of apoptosis markers, p21, p27, prostate-specific antigen (PSA), prostate-specific membrane antigen, and VDR expression in tumor-associated vascular endothelial cells and endothelium derived from normal-appearing prostate and tumor in these patients.
- Determine the acute effects of this regimen on serum PSA in these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a two-stage, randomized, pilot study.
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Stage 1: Patients are randomized to 1 of 2 treatment arms.
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Arm I: Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery. Within 48 hours of the last dose, patients undergo radical prostatectomy.
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Arm II: Patients receive no study drugs, but undergo radical prostatectomy.
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Stage 2: If sufficient activity is seen with the dexamethasone and calcitriol regimen in stage 1, the study is expanded and additional patients are randomized to 1 of 4 treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Stage 1 Arm 3
Patients receive oral dexamethasone once daily on days 1-4.
干预措施: dexamethasone (Drug)
Stage 1, Arm 4
Patients receive oral calcitriol once daily on days 2-4.
干预措施: calcitriol (Dietary Supplement)
Stage 1, Arm I
Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.
干预措施: dexamethasone (Drug)
Stage 1, Arm II
No study drugs before surgery.
干预措施: clinical observation (Other)
Stage 1, Arm I
Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.
干预措施: calcitriol (Dietary Supplement)
结局指标
主要结局
Effect of Preoperative High-dose Calcitriol and Dexamethasone on Prostatic Tumor Vessel Density Measured at 1, 2, 3, and 12 Months Post Prostatectomy
时间窗: Up to 30 days of the last administration of study procedure
次要结局
- Determine the Effect of This Regimen on the Expression of Apoptosis Markers(Up to 30 days of the last administration of study procedure)
- Number of Participants With Adverse Events, Graded According to NCI CTCAE v2.0(Up to 30 days of the last administration of study procedure)
- Determine the Acute Effects of This Regimen on Serum PSA in These Patients.(Up to 30 days of the last administration of study procedure)
- Effect of Preoperative High-dose Calcitriol and Dexamethasone on Extent of Prostatic Intraepithelial Neoplasia (PIN) at 1, 2, 3, and 12 Months Post Prostatectomy(Up to 30 days of the last administration of study procedure)