NCT02922218Unknown不适用
Prospective Multi-Centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Enzalutamide.
Centro Nacional de Investigaciones Oncologicas CARLOS III26 个研究点 分布在 1 个国家目标入组 187 人开始时间: 2016年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 187
- 试验地点
- 26
- 主要终点
- To assess the prognostic value for overall survival of androgen receptor splicing variant 7 (AR-V7) and/or AR amplification in mCRPC patients
研究概览
简要总结
PROSENZA is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with enzalutamide
详细描述
This study is a prospective biomarker study of patients with mCRPC undergoing treatment with enzalutamide 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 adenocarcinoma 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 enzalutamide 160 mg every 24 hours.
- •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
结局指标
主要结局
To assess the prognostic value for overall survival of androgen receptor splicing variant 7 (AR-V7) and/or AR amplification in mCRPC patients
时间窗: Initially 48 months, currently 60 months
次要结局
- To analyze the correlation between biochemical and/or radiological response with AR-V7 expression and/or AR amplification in mCRPC patients treated with Enzalutamide.(Initially 48 months, currently 60 months)
- To assess AR-V7 expression and/or AR amplification changes before and after enzalutamide treatment(Initially 48 months, currently 60 months)
- To validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients in these patients(Initially 48 months, currently 60 months)
- To explore the correlation between AR-V7 expression and AR amplification with other biomarkers as testosterone serum levels, PTEN loss or TMPRSS-ERG fusions in mCRPC patients treated with Enzalutamide(Initially 48 months, currently 60 months)
研究者
研究点 (26)
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