NCT02742259撤回不适用
Prospective, Multi-Center Validation of the Prostate Cancer Assay
Celsee Diagnostics0 个研究点开始时间: 2016年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Confirmation of the clinical utility of the cutoff level for the Prostate Cancer Assay for prognosis of progression free survival (PFS) in comparison to the predicate device, CellSearch CTC Assay
研究概览
简要总结
The Prostate Cancer Assay performance of Celsee Diagnostics circulating tumor cell (CTC) analysis system will be validated in patients diagnosed with metastatic prostate cancer. It will demonstrate substantial performance equivalency to a CTC Assay predicate device.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •• Male aged 18 years and above
- •Be willing to sign an informed consent document indicating that the subject understands the purpose of and procedures required for the study and are willing to participate in the study
- •Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
- •Eastern cooperative group (ECOG) performance status ≤2
- •Documented histologically confirmed adenocarcinoma of the prostate
- •Metastatic prostate cancer to the bone as documented by positive bone scan imaging
- •CRPC patient being considered for systemic therapy or in between lines of therapies (>= 14 days from prior treatment) for metastatic disease. Patient must have evidence of castrate resistant prostate cancer as evidenced by a confirmed rising PSA (per Prostate Cancer Working Group 2 [PCWG2] criteria) and a castrate serum testosterone level (i.e. ≤ 50 mg/dl).
排除标准
- •• Subjects actively receiving systemic therapy regimens, or between lines of therapies (< 14 days from prior treatment)
- •Have any condition that, in the opinion of the investigator, would compromise the wellbeing of the subject or the study or prevent the subject from meeting or performing study requirements
- •Active infection or other medical condition that would make corticosteroids (i.e. prednisone) use contraindicated
- •Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg) Patients with a history of hypertension are allowed provided blood pressure is controlled by antihypertensive treatment
- •Severe hepatic impairment (Child-Pugh Class C)
- •History of pituitary or adrenal dysfunction (note: the use of daily steroids does not exclude someone from participating in this study)
- •Have poorly controlled diabetes (HgB A1C ≥ 8%)
- •Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
- •Abnormal bone marrow function (absolute neutrophil count [ANC] < 1500/mm3, platelet count <100,000/mm3, hemoglobin <9 g/dL)
- •Abnormal liver function (bilirubin > upper limit of normal [ULN]; AST and/or ALT > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN)
- •Abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)
- •Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, unstable atrial fibrillation, or New York Heart Association (NYHA) Class III-IV heart disease
- •History of ventricular tachyarrhythmia within the past 5 years
结局指标
主要结局
Confirmation of the clinical utility of the cutoff level for the Prostate Cancer Assay for prognosis of progression free survival (PFS) in comparison to the predicate device, CellSearch CTC Assay
时间窗: 9 months
"CTC negative" means a level of CTCs below the cutoff indicating lower risk for progression (i.e. PFS, and "CTC positive" means a level of CTCs at or above the cutoff indicating higher risk for progression (i.e. shorter PFS).
次要结局
未报告次要终点
研究者
相似试验
招募中
不适用
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical TrialsProstate AdenocarcinomaProstate Cancer MetastaticCastration-resistant Prostate CancerProstate CancerNCT06141993Duke University120
撤回
不适用
Detection of Prostate Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMCProstate AdenocarcinomaProstate Cancer MetastaticProstate CancerNCT03494803HKGepitherapeutics
Unknown
不适用
Establishment and Clinical Assessment of a Prostate Cancer (PCa) Risk Model Based on the Updated Circulating Tumor Cell (CTC) Detection TechniqueProstatic AdenomaProstatic NeoplasmsNCT02940977Xinhua Hospital, Shanghai Jiao Tong University School of Medicine120
已完成
不适用
Validation of the Stockholm3 Test for Detection of Prostate Cancer in the Swiss PopulationLocalized CarcinomaProstate CancerNCT05294627University Hospital, Basel, Switzerland380
进行中（未招募）
2 期
Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate CancerProstate CancerNCT03976843National Cancer Institute (NCI)175