Status:
NOT_YET_RECRUITING
PRostate Cancer Enhanced Diagnosis by Calibration Technology
Lead Sponsor:
Gold Standard Phantoms
Collaborating Sponsors:
Bioxydyn Ltd, Manchester
National Cancer Imaging Translational Accelerator
Conditions:
Prostate Cancers
Eligibility:
MALE
18+ years
Brief Summary
The CARE® Phantom system is a medical device system that is being developed has been designed to enable the quantitative measurement of the apparent diffusion coefficient (ADC) in the prostate of pati...
Eligibility Criteria
Inclusion
- Men aged 18 years and older undergoing investigations for PCa.
- Standard of Care MRI conducted.
- One or more lesions with a Likert score of 3 or above identified on clinical reports.
- Planned targeted biopsy within 6 months from the date of clinical care MRI.
- Willing and able to provide written informed consent.
Exclusion
- Prostate specific antigen (PSA) level \> 20ng/ml within 6 months
- Previous diagnosis of prostate cancer
- Ongoing hormone treatment within 3 months prior to MRI, excluding antiandrogens or 5-alpha reductase inhibitors
- Contraindication to MRI scan
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06607783
Start Date
September 1 2025
End Date
December 1 2026
Last Update
August 28 2025
Active Locations (1)
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1
University College Hospital
London, London, United Kingdom, WC1E 6AG