NCT00911027终止3 期
A Phase III Study to Compare SonoVue Guided Prostate Biopsy With Systematic Biopsy in the Detection of Prostate Malignant Lesions in Patients With Suspected Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 282
- 试验地点
- 17
- 主要终点
- Determination of potentiality of SonoVue to guide prostate biopsy increasing detection rate of malignant lesions of 6% points (absolute terms) compared to detection rate of conventional systematic biopsy on patients candidates to a bioptic procedure.
研究概览
简要总结
This is a phase III European multicenter, open label, prospective study to assess the diagnostic accuracy of the use of SonoVue contrast agent to guide prostate biopsies in comparison with the current practice of ultrasound guided systematic biopsy. The trial will involve 15-20 European Centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patient, age ≥ 40 years old
- •Optimization part only: Diagnosis of prostate cancer
- •Main part: Suspected prostate cancer scheduled for first biopsy and tPSA ≤ 10 ng/mL OR already submitted to one systematic bioptic procedure with negative results currently under follow up procedure due to a persistent indication.
- •Written Informed Consent and willing to comply with protocol requirements
排除标准
- •Documented acute prostatitis or urinary tract infections
- •Known allergy to sulphur hexafluoride micro bubbles
- •Any clinically unstable cardiac condition within 7 days prior to SonoVue® administration such as:
- •evolving or ongoing myocardial infarction
- •typical angina at rest within the previous 7 days
- •significant worsening of cardiac symptoms within the previous 7 days
- •recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of ECG, laboratory or clinical findings)
- •acute cardiac failure, class III/IV cardiac failure
- •severe cardiac rhythm disorders
- •right-to-left shunts
- •Severe pulmonary hypertension or uncontrolled systemic hypertension or respiratory distress syndrome
- •Bioptic procedure within 30 days before admission into this study (this exclusion criterion is only for the main part of the study)
- •Determined by the Investigator that the patient is clinically unsuitable for the study
- •Participation in a concurrent clinical trial or in another trial within the past 30 days
- •Repeated participation in this trial (the patient should not be enrolled twice in the present study)
研究组 & 干预措施
SonoVue guided biopsy
Experimental
干预措施: Contrast-enhanced ultrasound guided biopsy (Drug)
Systematic biopsy
Other
干预措施: ultrasound guided systematic biopsy (Procedure)
结局指标
主要结局
Determination of potentiality of SonoVue to guide prostate biopsy increasing detection rate of malignant lesions of 6% points (absolute terms) compared to detection rate of conventional systematic biopsy on patients candidates to a bioptic procedure.
时间窗: Day 1
次要结局
- Evaluation of the rate of patients negative to the systematic biopsy among the population that will not receive the targeted biopsy(Day 1)
- Assessment of potentiality of SonoVue guided biopsy to increase % of positive bioptic cores compared to % of positive cores obtained with systematic biopsy, intra-patient in the population of the patients that received both bioptic procedures.(Day 1)
- Evaluation of the Gleason Score of bioptic samples and its relationship with the contrast enhanced signal assessment scores.(Day 1)
研究者
研究点 (17)
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