KCT0005611已完成未知
efficacy and tolerability of 3- and 6- month leuprorelin acetate depot formulations (Eligard) for patients with prostate cancer
Chung-Ang Univerisity Hospital0 个研究点目标入组 26 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 26
研究概览
简要总结
We demonstrated the non-inferiority and confirmed the safety of Eligard® 6-month regimen following a 3-month regimen compared to Eligard® 3-month regimen following a 6-month regimen in prostate cancer patients
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 0No Limit 至 0No Limit（—）
- 性别
- Male
入选标准
- •1) Men over 19 years of age
- •2) ECOG performance status is within 0-2 and the purpose of the study
- •Who understand and agree in writing to participate in the research
- •3) Patients confirmed as adenocarcinoma as a result of prostate biopsy
- •4) In the case of patients who cannot or are at high risk for prostate biopsy,
- •If it is possible to diagnose lip adenocarcinoma (more than 100 ng/ml of PSA, or/and in imaging
- •Clear prostate cancer lesions or/and obvious metastatic lesions on imaging tests, etc.)
- •5) Among prostate cancer patients, they were diagnosed with stage metastatic (stage D1, D2) and were treated with hormones.
- •6) Primary ADT for high-risk local or locally advanced prostate cancer (stage A, B)
- •7) Adjuvant therapy after radiotherapy or radical prostatectomy in prostate cancer patients.Patients planning hormone therapy
排除标准
- •1) Severe heart disease (unstable angina, congestive herat failure), severe renal impairment Ruler (GFR <30 ml/min/1.73m2
- •), patients with severe liver failure (Child-Pugh class B, C)
- •2) Patients with hypersensitivity or allergic symptoms to Leuprorelin acetate
- •3) Severe cognitive dysfunction and psychiatric problems are inappropriate for surveys and verbal communication. character
- •4) Those who are inappropriate to participate in clinical trials under the judgment of the investigator
研究者
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