NCT00673127已完成2 期
A Phase II Trial of Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer
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
- 57
- 试验地点
- 7
- 主要终点
- PSA Response
研究概览
简要总结
The combination of ketaconazole and hydrocortisone is commonly used for the treatment of prostate cancer. The purpose of this study is to determine if the addition of a drug called dutasteride to this approved combination will make the combination more effective in treating prostate cancer.
详细描述
- Participants will be seen by the study physician every four weeks and have a short physical examination, blood tests and be asked to provide information about their condition. Every three months they will undergo a bone scan. If the CT scan that was obtained before the participant started the study shows evidence of cancer, they will be asked to repeat this test every three months.
- Ketaconazole will be taken orally three times a day on an empty stomach. Hydrocortisone will be taken orally in the morning and at night. Dutasteride will be taken orally once a day.
- Participants may remain on study drug until there is evidence of disease progression.
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
- •Histologically documented evidence of prostate cancer (needle biopsy or prostatectomy). In the abscence of histologically documented evidence of prostate cancer, the diagnosis must be based on elevated serum PSA and metastatic lesions on bone scan.
- •Progressive HRPC defined as a PSA increase over baseline of >25% or 5ng/ml or new lesions on bone/CT scan after conventional androgen deprivation and antiandrogen withdrawal. Evidence of metastatic disease based on positive CT or bone scan is not required.
- •PSA of greater than or equal to 2ng/ml and serum total testosterone less than or equal to 50ng/ml
- •Prior chemotherapy is permitted if discontinued > 4 weeks prior to starting therapy
- •Prior therapy with estrogens is permitted but must have been discontinued > 4 weeks prior to registration
- •ECOG Performance Status 0-2
- •Adequate renal function, hepatic function, and bone marrow function as outlined in protocol
- •ECG showing a normal QT interval
排除标准
- •Prior therapy with ketoconazole or corticosteroids for HRPC
- •Major surgery or radiation therapy within 4 weeks
- •Strontium-89 or samarium-153 therapy within 4 weeks
- •Thromboembolism in past 6 months
- •Patients who are taking drugs that may further prolong QT intervals and present a known risk for Torsades de Pointes.
- •Concomitant use of drugs known to be narrow therapeutic index CTP3A4
- •Drugs that are sensitive CYP3A4 substrates
- •Alcohol or drug dependence currently or in the last 6 months
研究组 & 干预措施
KHAD
Experimental
Ketoconazole, Hydrocortisone and Dutasteride Ketoconazole: 200mg orally three times a day on an empty stomach. Hydrocortisone: 30mg in the morning and 10mg in the evening. Dutasteride: 0.5 mg once a day
干预措施: Ketoconazole, Hydrocortisone and Dutasteride (Drug)
结局指标
主要结局
PSA Response
时间窗: From treatment initiation until treatment cessation. Maximum 32 months. Median treament duration 8 months.
PSA decline of 50% from baseline confirmed by a PSA at least 4 weeks later.
次要结局
- Time to Progression(Duration of time from treatment initiation until documented progression. Maximum 32 months)
研究者
Steven Balk, MD
Principle Investigator
Dana-Farber Cancer Institute
研究点 (7)
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