NCT00586898已完成2 期
Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Response
研究概览
简要总结
Objective: To determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer.
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
- •Patients residing in the following clinical states wit! be considered: A. Rising PSA: Patients with a history of localized disease who have undergone definitive radiation or surgery. These patients must demonstrate progression of disease biochemically as outlined below. Patients in this group may not have radiographically evident disease.
- •B. Non-castrate metastatic: Patients must present with radiographic evidence of metastatic disease at the time of diagnosis or after treatment for localized disease. These patients must show newly detected disease or progressing disease in bone or in soft tissue. Biochemical progression is defined as: minimum no. of determinations: 3 Interval: >2 weeks Minimal Baseline PSA value (ng/ml): 2 Minimal % increase in range of values: 50%
- •Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC.
- •Patient must have level of serum testosterone above the lower limit of normal.
- •Karnofskcy performance status (KPS) >_70%.
- •Patients must have adequate organ function as defined by the following laboratory criteria:
- •WBC >_3500/mm3, platelet count >_100,000/mm
- •Bilirubin <2.0 mg/dl or SGOT <3.0 X the upper limit of normal.
- •Creatinine <_1.6 mg/dl or creatinine clearance >_60 cc/min.
- •Prior hormonal therapy is allowed as:
- •Neoadjuvant treatment prior to radiation therapy or radical prostatectomy, provided that the total duration of exposure does not exceed 10 months.
- •One cycle of intermittent therapy up to a maximum exposure of 10 months.
- •Patients must be at least 18 years of age.
- •Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment
排除标准
- •Clinically significant cardiac disease (New York Heart Association Class III/IV),or severe debilitating puhnonary disease.
- •Uncontrolled serious active infection.
- •Anticipated survival of less than 3 months.
- •Active CNS or epiduraltumor
- •Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests.
研究组 & 干预措施
1
Experimental
干预措施: Estrogen transdermal patch (Drug)
1
Experimental
干预措施: GnRH (Drug)
1
Experimental
干预措施: Ketoconazole (Drug)
1
Experimental
干预措施: Bicalutamide (Drug)
1
Experimental
干预措施: Testosterone transdermal gel (Drug)
结局指标
主要结局
Response
时间窗: 6 months
Complete Response: Normalization of the PSA (\< or = to 4.0 for patients with castrate metastatic disease, or \< 0.5 for patients with a rising PSA) that is maintained on 3 successive evaluations a minimum of 2 weeks apart. Partial Response: Decrease in PSA value by \> or = to 50% from baseline value (without normalization) for 3 successive evaluations a minimum of 2 weeks apart. Stabilization: Patients who do not meet the criteria for PR or PROG for at least 90 days will be considered stable.
次要结局
未报告次要终点
研究者
研究点 (1)
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