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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Page 1 of 1 (1 locations)

1

University College Hospital

London, London, United Kingdom, WC1E 6AG