Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain score assessment of CAMPROBE biopsy procedure
研究概览
简要总结
To evaluate the use of the CAMbridge PROstate Biopsy devicE (CAMPROBE) as a method of undertaking prostate biopsy as part of their clinical management.
详细描述
To assess patient's experience and complications of the CAMPROBE and compare the results with known published outcomes from standard transrectal biopsies .
To use data from the pilot study to determine the feasibility of a randomised trial comparing CAMPROBE with the current standard method of prostate biopsies.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Fit and well enough to undergo a repeat prostate biopsy
- •Men who have previously had a transrectal ultrasound biopsy of the prostate and due to have a repeat biopsy as part of normal care
- •Men on active surveillance
- •Men on PSA monitoring
排除标准
- •Contraindication for a repeat prostate biopsy
- •Contraindication for a transperineal prostate biopsies
- •Previous perineal or anal surgery
- •MRI suggesting anterior lesion or extra capsular disease
- •MRI suggesting lesion that needs fusion image targeting
- •Unable to lie down and with legs in a stirrup for at least 45 minutes
结局指标
主要结局
Pain score assessment of CAMPROBE biopsy procedure
时间窗: 3 weeks
Measured using a 10 point visual pain score tool and a point based structured questionnaire
Patient reported adverse events related to CAMPROBE biopsy
时间窗: 3 weeks
Point based structured questionnaire assessment of adverse events after biopsy
Patient perception and acceptance of CAMPROBE biopsy
时间窗: 3 weeks
Point based structured questionnaire including willingness to recommend to a friend
次要结局
- Deterioration in urinary function after CAMPROBE biopsy(3 weeks)
- Deterioration in sexual function after CAMPROBE biopsy(3 weeks)
研究者
Vincent Gnanapragasam
Lecturer in Uro-oncology and Consultant Urological Surgeon
Cambridge University Hospitals NHS Foundation Trust