Predicting Prostate Cancer Using a Panel of Plasma and Urine Biomarkers Combined in an Algorithm in Elderly Men Above 70 Years
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 700
- 主要终点
- Test sensitivity
研究概览
简要总结
We aim to analyze whether the "liquid biopsy" model could increase the specificity of detecting men with an aggressive (defined as Gleason score ≥ 7) prostate cancer and thereby reduce the proportion of men who undergo prostate biopsy, while at the same time maintaining the same sensitivity to detect aggressive prostate cancer as the PSA test alone. Using blood and urine biomarkers together with an algorithm, which incorporates the clinical data, we aim to identify patients who have a high risk of having an aggressive prostate cancer. By performing this non-invasive test we expect that we can reduce need for prostate biopsy and reduce the detection of patients with an indolent prostate cancer (defined by Gleason score ≤ 6). Thereby we aim to reduce the side effects of transrectal ultrasound guided biopsy of the prostate and side-effects of living with an indolent cancer.
详细描述
BACKGROUND Prostate biopsy is currently the standard of care for prostate cancer diagnosis, oftentimes reflexed after the detection of an elevated serum prostate-specific antigen (PSA). Unfortunately, prostate biopsy is not without potential complications, which include discomfort, pain, bleeding, and infections ranging from cystitis to septic sepsis and even death. Bleeding has been reported in 6-13% of patients undergoing prostate biopsy, while 0.3-4% experience admission with sepsis. Furthermore, some newly diagnosed prostate cancers are indolent while other may be more aggressive with metastatic potential, with resultant risk of death. A PSA level ≥4.0 ng/ml is frequently used as a threshold warranting a biopsy evaluation. Elevated PSA level may reflect benign prostatic hyperplasia (BPH), inflammation, or malignancy. Some series suggest that only 20-30% of patients with PSA 4 - 10 ng/ml, have prostate cancer, resulting in a high number of patients undergoing an unnecessary biopsy. We recently reported the ability of "Liquid Biopsy" to predict the presence of aggressive prostate cancer using a combination of biomarkers detected in urine and peripheral blood plasma. Concluding that "Liquid Biopsy" can predict the presence of aggressive prostate cancer (GS ≥7).
AIM With this study we want of compare "Liquid Biopsy", defined by our blood and urine panel against prostate biopsy in a large-scale randomized manner including men referred for a biopsy due to the suspicion of prostate cancer over the age of 70 (elderly).
OBJECTIVE The primary objectives of this study are to test the ability of the "liquid biopsy" to
- Detect as many patients with aggressive prostate cancer as the standard method (PSA).
- Reduce the number of prostate biopsy sets taken and thereby reduce the number of patients detected with indolent prostate cancer.
The secondary objectives are to evaluate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Suspicion of prostate cancer due to elevated PSA, and/or palpable tumor in the prostate
- •Indication for digital rectal examination and trans-rectal ultrasound with biopsy
- •Age: 70 years or above
- •PSA: 20 or above
- •Able to provide informed written consent (competent adults only)
排除标准
- •Previously diagnosed with prostate cancer
- •Receiving treatment influencing PSA levels
- •Medical conditions that may interfere with the study such as previously cancer-related therapy
- •Life expectancy of less than 10 years
- •MRI of the prostate within the last 2 years
- •Digital rectal examination of the prostate within 24 hours or ejaculation within 24 hours
研究组 & 干预措施
Liquid Biopsy
Experimental arm where the "liquid biopsy" decides whether to perform an prostate biopsy or not
干预措施: Liquid Biopsy (Diagnostic Test)
Standard Biopsy
Standard arm, where every patient receives a standard prostate biopsy
干预措施: Standard biopsy (Diagnostic Test)
结局指标
主要结局
Test sensitivity
时间窗: 2 years
Number of detected patients with aggressive prostate cancer, defined as Gleason score ≥ 7.
Test specificity
时间窗: 20 years
Number of patients who had prostate biopsies
次要结局
未报告次要终点
研究者
Mads Hvid Poulsen
MD, PhD, Associate professor
Odense University Hospital