DRKS00008554进行中（未招募）不适用
Evaluation of Circulating Tumors Cells (CTCs) as Potential Surrogate Marker for Further Definition und Subclassification of non metastatic High-Risk Castration Resistant Prostate Cancer Patients - NIS Pro-CTC
OnkoDataMed GmbH0 个研究点目标入组 5 人开始时间: 2015年6月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- Male
入选标准
- •1.Men with histologically confirmed prostate cancer
- •2.Age = 18 years
- •3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •4.Chemical or surgical castration defined as:
- •bilateral orchiectomy (also referred to as orchidectomy) at least 6 months before CTC measurement, OR
- •continuous androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) agonist or antagonist for at least 6 months before CTC measurement
- •5.Total serum testosterone level of < 50 ng/dL (1.72 nmol/L)
- •6.Castration resistant prostate cancer demonstrated during continuous ADT/post-orchiectomy defined as:
- •3 consecutive PSA values with PSA1 < PSA2 < PSA3
- •each PSA value must be separated by at least 2 weeks
- •PSA2 and PSA3 = 1.0 ng/mL
- •7.High risk for development of bone metastasis and detection of CTCs defined as:
- •Gleason score 3+4 or higher and
- •PSA value = 8.0 ng/mL, obtained no more than 3 months before inclusion and
- •PSA doubling time = 10 months
- •8.Before any study-specific procedure, the appropriate written informed consent must be obtained
- •9.Adequate organ function, as defined by the following criteria:
- •Serum aspartate aminotransferase (AST) = 2.5 x upper limit of normal (ULN)
- •Serum alanine aminotransferase (ALT) = 2.5 x ULN
- •Serum total bilirubin = 1.5 x ULN
- •Serum calcium or albumin-adjusted serum calcium = 2.0 mmol/L (8.0 mg/dL) and = 2.9 mmol/L (11.5 mg/dL)
- •10.Routine blood draw which permits the number of circulating tumor cells (CTC) to be measured by the CellSearch® System of Veridex
- •11.Before any study-specific procedure, the appropriate written informed consent must be obtained
排除标准
- •1.Prior or current evidence of radiographically detectable bone metastasis as evidenced by bone scan not elder than 6 weeks relative to the time of CTC measurement
- •2.Known prior or current evidence of any metastatic involvement of distant organs (lymph node metastases in any region is acceptable)
- •3.Prior or current i.v. bisphosphonate administration
- •4.To exclude any influence of prior bone therapy on occult tumor cells: Prior or current use of oral bisphosphonates as follows:
- •greater than or equal to 3 years continuously
- •greater than 3 months but less than 3 years (eligible if subject has a 1 year washout before study entry)
- •5.To exclude any influence of prior bone therapy on occult tumor cells: Prior administration of denosumab
- •greater than or equal to 3 years continuously
- •greater than 3 months but less than 3 years (eligible if subject has a 1 year washout)
- •6.Three months or less since receiving a non-bone related investigational product or device in a clinical trial.
- •7.12 months or less since receiving a bone related investigational product or device in a clinical trial.
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