EUCTR2016-004452-29-IT进行中（未招募）1 期
Randomized, multicentre phase II trial of the sequencing of Radium-223 and Docetaxel plus prednisone in symptomatic bone-only metastatic castration-resistant prostate cancer (mCRPC) - RAPSO
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS0 个研究点目标入组 70 人开始时间: 2018年9月20日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Patients must have histologically or cytologically confirmed adenocarcinoma of prostate
- •2. Two or more bone metastases confirmed by bone scintigraphy within 4 weeks prior to study entry
- •3. Known castration-resistant disease, defined according to PCWG3 criteria as: castrate serum testosterone level: =50 ng/dL (=1.73 nmol/L)
- •4. Subjects who have failed initial hormonal therapy, either by orchiectomy or by using a GnRH agonist in combination with an anti-androgen, must first progress through antiandrogen withdrawal prior to being eligible. The minimum timeframe to document failure of anti-androgen withdrawal will be four weeks
- •5. Progressive disease based on PSA and/or radiographic criteria
- •6. ECOG performance status =2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •1. Patients who have had previous chemotherapy.
- •2. Patients who have had radiotherapy within 4 weeks prior to entering the study.
研究者
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