A Randomized, Double Blind, Placebo-Controlled Trial of Celecoxib Versus Placebo in Men With Prostate Cancer With Rising PSA Following Prostatectomy or Radiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 18
- 主要终点
- To evaluate the biologic activity of celecoxib by comparing the proportion of men with a post-treatment PSA doubling time (PSADT) greater than or equal to 200% pre-treatment PSADT in the celecoxib-treated group compared to the placebo-treated group
研究概览
简要总结
The purpose of this study is to learn the effects (both good and bad) that celecoxib has on prostate cancer and patients with prostate cancer. This study is looking at what effects celecoxib has on prostate specific antigen (PSA) level. PSA is a marker specific to prostate cancer. An increase or decrease in this level in the blood can indicate if a patient's prostate cancer is getting worse or better.
详细描述
This study is designed as a randomized, double blind, placebo-controlled study. These are all scientific research methods used to protect the study from personal bias or prejudice.
Patients who participate in this study will be randomly assigned initially to take either celecoxib (the study drug) or placebo (an inactive substance that looks like the study drug). Placebos are used to help determine if the results of a study (good or bad) result from chance or from treatment with the study drug. Patients will have a fifty-fifty chance of initial treatment with the study drug. Neither the patient nor the patient's doctor will know whether he/she is initially receiving the study drug or placebo. Participants who are assigned to initially take placebo may have the opportunity to be treated with celecoxib later in the study.
If patients are found to be eligible for this study and they agree to participate, they will be randomized to either receive celecoxib or placebo to be taken by mouth (as a pill) twice a day, every day for as long as they are in the study. Patients will be given a pill diary to keep track of their medications. While in this study, they will be asked not to take any non-steroidal anti-inflammatory drugs, which includes over-the-counter ibuprofen and many other available drugs. In addition, they will be asked not to take any other selective COX-2 inhibitors (the class of drug that celecoxib is).
While in this study, patients will have evaluations (physical exam and blood) to determine their response to their assigned regimen and to monitor side effects.
Once a month the following will be performed:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
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
- •Diagnosis of prostate cancer
- •Progression following prostatectomy or radiation to the prostate, defined as 3 PSA rises, with each PSA determination at least 4 weeks apart
- •PSA greater than or equal to 1.0 for men who had a prostatectomy
- •PSA greater than or equal to 3.0 for men who were treated with primary radiation therapy (external beam and/or brachytherapy)
- •PSA doubling time between 6 and 24 months
- •Participants must be either fully active and asymptomatic or symptomatic but fully ambulatory
- •Adequate bone marrow function, kidney function and liver function as evidenced by laboratory results
排除标准
- •Evidence of metastatic disease
- •Prior hormonal therapy for recurrent prostate cancer
- •Prior chemotherapy for recurrent or metastatic prostate cancer
- •Radiation therapy within 6 months
- •Patients allergic to non-steroidal anti-inflammatory drugs (NSAIDs), salicylates or sulfonamide-type medications who experience asthma or urticaria (hives) after taking aspirin or other NSAIDs
- •Patients taking a dose of aspirin greater than or equal to 325 mg a day within 4 weeks of study entry
- •Patients taking selective COX-2 inhibitors or any NSAIDs other than aspirin within 8 weeks of study entry
- •Patients taking fluconazole, lithium or warfarin
- •History of gastrointestinal or abdominal ulceration or any history of significant gastrointestinal bleeding in the past 12 months
- •Any history of myocardial infarction in the past 12 months
- •Any uncontrolled, serious medical or psychiatric illness
结局指标
主要结局
To evaluate the biologic activity of celecoxib by comparing the proportion of men with a post-treatment PSA doubling time (PSADT) greater than or equal to 200% pre-treatment PSADT in the celecoxib-treated group compared to the placebo-treated group
次要结局
- To compare changes in PSADT between the first and second six-month treatment periods for those in the placebo-treated group
- to correlate COX-2 expression in the patients' original prostate samples with biologic activity of celecoxib (when feasible)
- to correlate changes in plasma vascular endothelial growth factor (VEGF) levels in patients with biologic activity of celecoxib