PRospective Prostate biOmarker Study (PROPOSe)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 455
- 试验地点
- 11
- 主要终点
- Diagnosis of PCA
研究概览
简要总结
• Correlation of a glycoprotein panel with prostate biopsy outcome and PCa aggressiveness
详细描述
The main objective of this study is to correlate a glycoprotein panel with prostate biopsy outcome, i.e. distinguishing PCa from benign prostatic conditions as well as high-grade cancer. The quantities of the two protein analytes cathepsin D (CTSD) and thrombospondin 1 (THBS1) are measured in human serum samples. In combination with percent free PSA (%fPSA), the results are correlated with prostate biopsy outcome. The potential future benefit of using this glycoprotein panel is to validate positive tPSA tests in men with negative digital rectal examination (DRE) and enlarged prostates to reduce the need for undergoing a biopsy, thereby reducing unnecessary biopsies and potentially predicting high-grade disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patient between 45 and 80 years old.
- •tPSA between 2 and 10 ng/ml
- •Prostate volume >=35 ml
- •Non-suspicious DRE for prostate cancer
- •Scheduled for prostate biopsy
- •Patient must give written informed consent
排除标准
- •Patient not undergoing biopsy of the prostate
- •Prior prostate biopsy within the last 12 months
- •Transurethral resection of the prostate (TURP) in the last 5 years
- •Patients with known acute or chronic prostatitis/cystitis or other known prostate abnormalities
- •Patient taking 5-alpha-reductase inhibitor
- •Any other prior treatment of the prostate (cryoablation, hifu, ire, radiation therapy, alcohol instillation, etc.)
结局指标
主要结局
Diagnosis of PCA
时间窗: 12 months
Correlation of the glycoprotein panel algorithm with histological diagnosis of PCa
Aggressiveness of PCA
时间窗: 12 months
Correlation of the glycoprotein panel algorithm with diagnosis of significant (Gleason Score ≥7) PCa
次要结局
未报告次要终点