NCT00078910已完成2 期
A Prospective Phase II Study of Preoperative, Controlled Exisulind Therapy Initiated Prior to Radical Prostatectomy: Effect on Apoptosis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 3
- 主要终点
- Apoptosis 4 weeks after completion of study as assessed by marker analysis (bcl-2, Bax, Par-4, M30, TUNEL assay, PTEN)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as exisulind, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well neoadjuvant exisulind works in treating patients who are undergoing radical prostatectomy for stage II or stage III prostate cancer.
详细描述
OBJECTIVES:
Primary
- Compare the effect of neoadjuvant exisulind vs no neoadjuvant treatment on apoptosis in patients with stage II or III prostate cancer undergoing radical prostatectomy.
Secondary
- Determine the effect of this drug (preoperatively) on surrogate endpoint biomarkers (i.e., prostate-specific antigen, high-grade prostatic intraepithelial neoplasia, MIB-1, and DNA ploidy) in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •Clinical stage T1c-3b, N0-X, M0
- •Gleason score ≥ 6
- •Planning to undergo pelvic lymphadenectomy and radical prostatectomy at Mayo Clinic Rochester
- •Interval from biopsy to prostatectomy is at least 4, but no more than 14, weeks
- •Selected patients of Dr. R. P. Myers who are undergoing prostatectomy during the enrollment period will be assigned to the control group* NOTE: *Additional historical controls may be selected from Dr. Myers' patients who underwent prostatectomy within the past 4 years
- •PATIENT CHARACTERISTICS:
- •40 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •ALT normal (10-45 U/L)
- •AST normal (12-31 U/L)
- •Alkaline phosphatase normal (119-309 U/L)
- •Bilirubin normal (0.1-1.0 mg/dL)
- •No history of hepatitis, cirrhosis, or other hepatic dysfunction
- •Creatinine < 1.5 mg/dL
- •Fertile patients must use effective contraception
- •No hypersensitivity to sulindac (treatment group)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent immunotherapy
- •Chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy
- •No prior ablation (treatment group)
- •No prior hormone replacement or antiandrogen therapy (e.g., testosterone, diethylstilbestrol, leuprolide, goserelin, flutamide, bicalutamide, finasteride, nilutamide, or megestrol)
- •No concurrent antiandrogen therapy, luteinizing hormone-releasing hormone agonists, finasteride, or diethylstilbestrol
- •Radiotherapy
- •No prior pelvic radiotherapy
- •No concurrent radiotherapy
- •See Disease Characteristics
- •No prior treatment for prostate cancer before prostatectomy (control group)
- •No concurrent cyclooxygenase-2 inhibitors
- •No concurrent sulindac
- •No concurrent nonsteroidal anti-inflammatory drugs except low-dose (no more than 325 mg/day) aspirin for cardiovascular prophylaxis
排除标准
- 未提供
结局指标
主要结局
Apoptosis 4 weeks after completion of study as assessed by marker analysis (bcl-2, Bax, Par-4, M30, TUNEL assay, PTEN)
次要结局
- Modulation of other surrogate endpoint biomarkers (prostate-specific antigen high-grade prostatic intraepithelial neoplasia, MIB-1, and DNA ploidy)
研究者
研究点 (3)
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