NCT04146077招募中不适用
Active Surveillance Methodology for Low Risk Prostate Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- cancer progression
研究概览
简要总结
An active surveillance protocol for patients diagnosed low-risk prostate cancer will be held. We plan to use PSA (prostate-specific antigen) testing, DRE (digital rectal examination), TRUS (transrectal ultrasound), MRI (magnetic resonance imaging) and follow-up biopsies to monitor patients and detect cancer progression in time.
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •prostate adenocarcinoma verified by at least 12 core biopsy
- •patient must understand the sense of research, agree to participate and sign a form of agreement
- •low oncological risk according to EAU (European Association of Urology) Guidelines: stage T1-T2a, PSA<10 ng/ml, ISUP (International Society of Urological Pathologists score)=1 (Gleason score 3+3=6)
- •not more than 33% cores with adenocarcinoma
排除标准
- •previous treatment of prostate cancer
- •other prostatic malignant neoplasms
- •other oncological diseases
- •treatment with 5-alfa-reductase inhibitors
- •patient's refuse to continue study
- •patient's desire to begin treatment
结局指标
主要结局
cancer progression
时间窗: 5 years
Number of patients who had one of the following signs of cancer progression: new lesion on DRE proved by biopsy, or histological upgrade on follow-up biopsy, or involvement of more than 33% cores on follow-up biopsy
次要结局
- surgical treatment due to infravesical obstruction by BPH(5 years)
研究者
Dmitry Enikeev, MD, PhD
Deputy director for Research, Institute for Urology and Reproductive Health
I.M. Sechenov First Moscow State Medical University
研究点 (1)
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