A Trial Of COX-2 Inhibitors In PSA Recurrence After Definitive Radiation Or Radical Prostatectomy For Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Effect of COX-2 inhibitors on PSA level
研究概览
简要总结
RATIONALE: Celecoxib may stop the growth of cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who have relapsed prostate cancer following radiation therapy or radical prostatectomy.
详细描述
OBJECTIVES:
- Determine the effect of celecoxib on prostate-specific antigen (PSA) levels in patients with prostate cancer in biochemical relapse after prior definitive radiotherapy or radical prostatectomy.
- Compare the PSA doubling times in patients treated with this drug vs historical controls.
- Compare the PSA doubling times in patients treated with this drug vs pretreatment PSA values.
- Determine the time to clinical recurrence in patients treated with this drug.
OUTLINE: Patients receive oral celecoxib twice daily. Treatment continues for 5 years in the absence of disease progression. Patients may continue treatment beyond 5 years at the discretion of the treating physician.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of clinically localized adenocarcinoma of the prostate
- •T1 or T2 disease
- •Received prior primary treatment with definitive radiotherapy (at least 5,500 cGy) OR radical prostatectomy
- •Biochemical relapse within 5 years after prior primary therapy, defined as 1 of the following:
- •Detectable and rising prostate-specific antigen (PSA) after surgery (at least 2 values above the residual cancer detection limit of the assay)
- •PSA at least 2 values above 1 ng/mL OR at least 3 rising values at any level after radiotherapy
- •PSA no greater than 10 ng/mL
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •ALT no greater than 2.5 times upper limit of normal
- •Creatinine normal
- •No allergy to cyclooxygenase-2 inhibitors, aspirin, nonsteroidal anti-inflammatory drugs, or sulfa drugs
- •No untreated peptic ulcer disease
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy
- •Endocrine therapy
- •More than 6 months since prior adjuvant or neoadjuvant hormonal therapy
- •Duration of prior adjuvant or neoadjuvant hormonal therapy must have been no more than 6 months
- •Radiotherapy
- •See Disease Characteristics
- •Prior salvage radiotherapy after prostatectomy allowed
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Effect of COX-2 inhibitors on PSA level
时间窗: 9 months
To study the effect of COX-2 inhibitors on PSA level in patients who have only biochemical relapse after definitive radiation therapy or surgery for prostate cancer. In particular, to study the effect of celecoxib on PSA levels and PSA doubling times as compared to 1) historical controls (known and well-described median PSA doubling times of 9 months), and 2) pre-treatment PSA values and doubling times.
次要结局
- Disease progression rate(5 years)