Investigation of novel molecular imaging techniques for precision surgery and genomic characterisation of high-risk prostate cancer using EMI-137

niversity of Oxford0 sites2 target enrollmentJanuary 11, 2021

Overview

No summary available.

Registry

who.int

Start Date

January 11, 2021

End Date

December 17, 2020

Last Updated

5 years ago

Study Type

Interventional

Sex

Male

Sponsor

•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

•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