NCT02925702Unknown不适用
Prospective Multi-centre Study of Prognostic Factors in Metastatic Castration-Resitant Prostate Cancer Patients Treated With Radium-223.
Centro Nacional de Investigaciones Oncologicas CARLOS III63 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2016年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 161
- 试验地点
- 63
- 主要终点
- To validate the prognostic value for overall survival of serum bone metabolism markers descibed by Primo N Lara et al (JNCI 2014) in mCRPC patients treated with Radium-223
研究概览
简要总结
PRORADIUM is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with radium-223.
详细描述
This study is a prospective biomarker study of patients with mCRPC undergoing treatment with radium-223 as standard of care treatment. The participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male age ≥ 18 years
- •Histologically confirmed adenocarcinome of the prostate
- •ECOG Performance Status ≤ 2
- •Castration resistance must be documented with surgical or medical castration with serum testosterone < 50 ng/mL (< 2.0 nM).
- •Men diagnosed with at least one metastatic lesion on CT or bone scan.
- •Documented biochemical and/or radiographic progression to previous treatment according to PCWG2 criteria.
- •Patients who are candidates for standard of care treatment with Radium-223 55mBq/Kg very 4 weeks intravenously
- •Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy.
- •Acceptable hematological, hepatic and renal functions.
排除标准
- •Previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ carcinomas.
- •Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data
研究组 & 干预措施
Radium-223
Radium-223 55 mBq/Kg every 4 weeks IV
干预措施: Radium 223 55mBq/Kg every 4 weeks intravenously (Drug)
结局指标
主要结局
To validate the prognostic value for overall survival of serum bone metabolism markers descibed by Primo N Lara et al (JNCI 2014) in mCRPC patients treated with Radium-223
时间窗: Initially 48 months, currently 60 months
次要结局
- To assess the prognostic value for overall survival of androgen receptor splicing variant 7 (AR-V7) and/or AR amplification in mCRPC patients treated with Radium-223(Initially 48 months, currently 60 months)
- To analyze the prognostic value for biochemical and/or radiological progression-free survival of serum bone metabolism markers described by Primo N Lara et al in mCRPC patients treated with Radium-223(Initially 48 months, currently 60 months)
- To analyze the prognostic value of "Bone Scan Index" in mCRPC patients treated with Radium-223(Initially 48 months, currently 60 months)
- To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients(Initially 48 months, currently 60 months)
- Exploratory aims include: Validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients and analyze the prognostic value of the gene-expression signature described by Olmos et al on progression-free survival.(Initially 48 months, currently 60 months)
- To assess the prognostic value of alkaline phosphatase before- and after 3 cycles of treatment in these patients(Initially 48 months, currently 60 months)
- To validate the prognostic value of the gene-expression signature from peripheral blood described by Olmos et al (Lancet Oncol 2012) on overall survival of mCRPC patients(Initially 48 months, currently 60 months)
研究者
研究点 (63)
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