ISRCTN97555789已完成未知
Investigation of novel molecular imaging techniques for precision surgery and genomic characterisation of high-risk prostate cancer using EMI-137
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Men with histologically proven high-risk non-metastatic localized or locally advanced prostate cancer (PC):
- •1.1. Risk 1: serum PSA 10-20ng/ml and Gleason =4+3
- •1.2. Risk 2: serum PSA =20 ng/ml
- •1.3. Risk 3: grade group 4 or 5
- •1.4. Risk 4: clinical T3
- •2. Eligible for robot-assisted laparoscopic radical prostatectomy by the local standard of care
- •3. An understanding of the English language sufficient to understand written and verbal information about the trial and its consent process
- •4. Willing and able to give informed consent for participation in the study
- •5. Aged =18 years
排除标准
- •1. Unfit for radical surgery as assessed by Consultant Anaesthetist
- •2. History of any cancer, except non-melanoma skin cancer
- •3. Androgen suppression/hormone treatment within the previous 12 months for PC
- •4. Previous High-Intensity Focussed Ultrasound (HIFU), cryosurgery, thermal or microwave therapy to the prostate.
- •5. Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within 6 months. These patients may be included within the trial if deferred from consenting and screening until =6 months following the TURP.
- •6. Presence of metal implants/stents in the urethra
- •7. Renal impairment with a Glomerular Filtration Rate (GFR) of < 35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced Magnetic Resonance Imaging)
- •8. Unable to provide informed consent to participate in the trial as judged by the attending clinician
研究者
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