ISRCTN10046036暂停1 期
Investigation of novel molecular imaging techniques for precision surgery and genomic characterisation of high-risk prostate cancer using IR800 IAB2M
适应症
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 23
研究概览
简要总结
2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38853153/ (added 16/07/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •Current inclusion criteria as of 23/11/2021:
- •1. Histologically proven intermediate/high-risk untreated PC undergoing radical prostatectomy, where the indication for sparing the neurovascular bundle on either or both sides is equivocal.
- •2. Suitable for surgery by 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. Participant is willing and able to give informed consent for participation in the study.
- •5. Aged 18 years or above
- •Previous inclusion criteria:
- •1. Men with histologically proven high-risk non-metastatic localized or locally advanced (cT3) PC with any of the following risk criteria:
- •Risk 1: Serum PSA 10-20ng/ml and Gleason 4+3 or greater
- •Risk 2: Serum PSA =20 ng/ml
- •Risk 3: Grade group 4 or 5
- •Risk 4: Clinical T3
- •2. Eligible for robot-assisted laparoscopic radical prostatectomy by 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. Participant is willing and able to give informed consent for participation in the study
- •5. Aged 18 years or above
排除标准
- •Current exclusion criteria as of 23/11/2021:
- •1. Unfit for radical surgery
- •2. History of any cancer, except non-melanoma skin cancer
- •3. Presence of metal implants/stents in the urethra
- •4. Men with renal impairment with a Glomerular Filtration Rate (GFR) of <35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced Magnetic Resonance Imaging (MRI))
- •5. Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.
- •6. Unable to provide informed consent to participate in the trial as judged by the attending clinician
- •Previous exclusion criteria:
- •1. Unfit for radical surgery as assessed by Consultant Anaesthetist
- •2. History of any cancer, except non-melanoma skin cancer
- •3. Men who have had androgen suppression/hormone treatment within the previous 12 months for their PC
- •4. Men who have had previous High Intensity Focussed Ultrasound (HIFU), cryosurgery, thermal or microwave therapy to the prostate
- •5. Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within six months. These patients may be included within the trial if deferred from consenting and screening until at least six months following the TURP
- •6. Presence of metal implants/stents in the urethra
- •7. Men with renal impairment with a Glomerular Filtration Rate (GFR) of < 35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced Magnetic Resonance Imaging (MRI))
- •8. Serious nonmalignant disease (eg, hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
- •9. Unable to provide informed consent to participate in the trial as judged by the attending clinician
研究者
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