VALIDATION OF THE FUSION CEMEP SCORE FOR THE OMISSION OF SYSTEMATIC PROSTATE BIOPSY IN PATIENTS UNDERGOING MULTIPARAMETRIC MAGNETIC RESONANCE IMAGING-TARGETED BIOPSY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- DETECTION RATE OF CLINICALLY SIGNIFICANT PROSTATE CANCER
研究概览
简要总结
This study aims to prospectively validate the Fusion CEMEP score to assess the safety and efficacy of omitting systematic prostate biopsy in patients undergoing multiparametric magnetic resonance imaging-targeted biopsy. The main objective is to determine if target-only biopsy guided by the score is sufficient for clinically significant prostate cancer detection while reducing overtreatment and unnecessary cores.
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
- •Adult male patients with clinical suspicion of prostate cancer.
- •Patients scheduled to undergo multiparametric MRI-targeted prostate biopsy.
- •Signed informed consent.
排除标准
- •Prior treatment for prostate cancer.
- •Contraindications to prostate biopsy or multiparametric MRI.
研究组 & 干预措施
FUSION CEMEP SCORE COHORT, PROSPECTIVE COHORT
Patients evaluated with multiparametric MRI-targeted biopsy using the Fusion CEMEP score.
干预措施: FUSION CEMEP SCORE STRATEGY (Other)
结局指标
主要结局
DETECTION RATE OF CLINICALLY SIGNIFICANT PROSTATE CANCER
时间窗: AT THE TIME OF PROSTATE BIOPSY (WITHIN 30 DAYS OF EVALUATION)
Percentage of patients diagnosed with clinically significant prostate cancer (Gleason score \>= 7) using the target-only biopsy guided by the Fusion CEMEP score compared to the full systematic scheme.
次要结局
未报告次要终点
研究者
Marcelo Ruben Oliva
UROLOGIST
Servicio Urologia CEMEP