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Clinical Trials/ISRCTN10046036
ISRCTN10046036
Suspended
Phase 1

Investigation of novel molecular imaging techniques for precision surgery and genomic characterisation of high-risk prostate cancer using IR800 IAB2M

niversity of Oxford0 sites23 target enrollmentMarch 9, 2018
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ConditionsProstate CancerCancer

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
niversity of Oxford
Enrollment
23
Status
Suspended
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38853153/ (added 16/07/2024)

Registry
who.int
Start Date
March 9, 2018
End Date
October 31, 2026
Last Updated
last year
Study Type
Interventional
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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