Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 503
- 试验地点
- 13
- 主要终点
- Proportion clinically significant prostate cancer missed during follow up
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and effectiveness of a novel diagnostic strategy for prostate cancer, in which men with a moderate risk of prostate cancer are monitored using PSA and MRI instead of immediate biopsy,.
The main questions it aims to answer are:
- Is it safe to delay biopsy, making sure that clinical significant prostate cancers are not often missed?
- Does it reduce unnecessary biopsies and overtreatment?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Life expectancy > 10 years
- •initial PSA < 20 ng/ml
- •No signs of extracapsular disease on digital rectal examination
- •Intermediate-risk category for suspicion of prostate cancer determined by MRI results and PSA density (PSAD): PI-RADS 3 or PI-RADS 4 with PSAD =< 0.15
- •Mentally competent and able to comprehend the potential benefits and burdens of the study
- •Willing to undergo the follow-up protocol for a maximum of four years
- •written and signed informed consent
排除标准
- •Men who have previously undergone a prostate biopsy
- •Men who have a prior PCa diagnosis
- •using any (anti-)hormonal therapy, including 5-alpha-reductase inhibitors
- •Proven germline mutation for PCa (for example: BRCA1; BRCA2)
- •Secondary malignancy, besides basal cell carcinoma of the skin, for which the potential participant is receiving active treatment at the time of inclusion.
- •severe claustrofobia or other conditions that make (repeat) MRI unsuitable (e.g., metal implants, pacemakers)
结局指标
主要结局
Proportion clinically significant prostate cancer missed during follow up
时间窗: 48 months
Detection percentage of International Society of Urological Pathology Grade Group (ISUP GG)≥ 2 prostate cancer (= clinically significant prostate cancer) during 48 months of follow up compared with the percentage of total ISUP GG≥ 2 during the study, including any findings from end of study biopsies. ISUP grade groups range from 1 to 5, and a ISUP GG≥ 2 is defined as clinically significant prostate cancer.
Number of clinically insignificant prostate cancer detected
时间窗: 48 months
Detection of clinically insignificant prostate cancer (International Society of Urological Pathology Grade Group (ISUP GG) 1) during the 48 months of follow up compared to the total ISUP GG 1 including end of study biopsies.
Number of negative biopsies
时间窗: 48 months
Number of participants with negative biopsy results during the study including findings from the end of study biopsies.
次要结局
- Grade shifts(48 months)
- Detection of very high risk prostate cancer(48 months)
- Health-related quality of life (EPIC-26 score)(48 months)
- Estimated average cost per patient during 48-month follow-up(48 months)
- Anxiety symptomes (STAI-6 score)(48 months)
研究者
Harm H.E. Van Melick
MD PhD
St. Antonius Hospital