Multicenter Validation of the Stockholm3 Test on Men on Active Surveillance: the CHAS3-Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of the Stockholm3 test for detection of histological upgrading to ISUP Grade Group ≥2 at follow-up prostate biopsy
研究概览
简要总结
The CHAS3 trial studies whether the Stockholm3 blood test can reliably detect if prostate cancer becomes more aggressive in men who are being carefully monitored instead of treated right away (active surveillance). The goal is to see if this test can help doctors safely follow patients with fewer invasive procedures, such as repeated biopsies.
详细描述
The CHAS3 trial is a study carried out at several hospitals that follows men with prostate cancer who are being closely monitored through active surveillance. The study looks at how well the Stockholm3 blood test can predict whether the cancer has become more serious when the men later have their scheduled follow-up biopsy.
Men who are already on active surveillance and planned for a routine biopsy may be invited to join. Participants must be alive and must not have started any treatments such as surgery, radiation, hormone therapy, or chemotherapy. To avoid extra procedures, any study samples will be taken at the same time as the patient's regular follow-up visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult Men ≥ 18 y. o.
- •Men with low-risk prostate cancer (D'Amico risk classification) currently undergoing Active Surveillance (AS)
- •First inclusion in Active Surveillance (AS) after 1st January
- •Scheduled for follow-up with systematic and/or Magnetic Resonance Imaging (MRI)-targeted (fusion) prostate biopsies - Prostate Magnetic Resonance Imaging (MRI) performed within the past three months available
排除标准
- •- Prior prostate cancer treatment (surgery, radiation, chemotherapy, hormonal therapy).
- •Patient with intermediate- or high-risk prostate cancer
- •Urinary catheterization within the past 6-8 weeks
- •Contraindications to Magnetic Resonance Imaging (MRI) or biopsy
研究组 & 干预措施
Stockolm3 Blood test in prostate cancer patient under active surviellance
Diagnostic procedure
干预措施: Stockholm3 (Diagnostic Test)
结局指标
主要结局
Diagnostic accuracy of the Stockholm3 test for detection of histological upgrading to ISUP Grade Group ≥2 at follow-up prostate biopsy
时间窗: At time of follow-up biopsy (baseline visit; Day 0 of study procedures)
The Stockholm3 risk score (cutoff ≥11) will be evaluated for its ability to predict histological upgrading to ISUP Grade Group ≥2 at scheduled follow-up prostate biopsy in men undergoing active surveillance for prostate cancer. Diagnostic performance will be quantified using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic curve (AUC).
Prediction of the International Professional organisation for UroPathology (ISUP) Grade ≥ 2 at rebiopsies (using a ≥11 cutoff)
时间窗: From enrollment to the end of treatment at 30 days
Diagnostic prediction of ISUP ≥2 after a re-biopsie on prostate cancer patients
次要结局
- Sensitivity and specificity of the Stockholm3 test at predefined risk thresholds (≥11, ≥13, ≥15) for detection of ISUP Grade Group ≥2 prostate cancer(At time of follow-up biopsy (baseline visit))
- Comparative diagnostic accuracy of Stockholm3 test versus PSA density, PSA doubling time, and MRI progression for detection of ISUP Grade Group ≥2 upgrading(At time of follow-up biopsy)
- Change in patient-reported quality-of-life scores measured using the EPIC-26 questionnaire following prostate biopsy(Baseline and 30 days after prostate biopsy)
- Stockholm3, Prostate-specific antigen (PSA) density and Magnetic Resonance Imaging (MRI) progression(From enrollment to the end of treatment at 30 days)