Prostate cancer Cancer Malignant neoplasms of male genital organs
Conditions
Interventions
In Stage 1, the study team will test the hypothesis that EMI-137 can bind to and highlight only prostate cancer cells during surgery, without highlighting any healthy tissue. Stage 1 is a non-randomis
Sponsors
University of Oxford
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Optimal dose and timing of administration of EMI-137 before radical prostatectomy surgery measured using fluorescence image-guided RARP at 2 or 4 h after EMI-137 injection | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
United Kingdom
Contacts
Public ContactOxford University
Outcome results
None listed