Status:
ACTIVE_NOT_RECRUITING
Exploiting Risk-Based Risk Stratification in Early Prostate Cancer to Discriminate Progressors From Non-Progressors
Lead Sponsor:
University College, London
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
This study seeks to analyse MRI images and biological samples from 60 men diagnosed as having intermediate risk prostate cancer at baseline and one year afterwards to compare the molecular, genetic an...
Detailed Description
RECONCILE is a single centre, prospective, longitudinal observational cohort study. 60 consenting men with intermediate risk, gleason 3+4, prostate cancer under active surveillance will be recruited t...
Eligibility Criteria
Inclusion
- Male aged 18 years or above.
- Diagnosed with prostate cancer within 4 months of entry.
- Likert or PIRADS score greater than or equal to 4.
- PSA less than or equal to 15 ng.ml-1 in the last 6 months.
- mpMRI concordant with histology.
- Overall Gleason score 7 (3+4).
- Maximum cancer core length less than or equal to 10mm.
- Patients on active surveillance
Exclusion
- Any contraindication to MRI scans (e.g. metal implants, unmanageable claustrophobia)
- Presence of a pacemaker
- Presence of a hip replacement
- Any hormonal treatment or inhibitors of 5 alpha-reductase in the previous 6 months
- Any previous TURP or other prostate surgery.
- Previous treatment for prostate cancer.
- Patients who have previously had sepsis due to a prostate biopsy
- Patients receiving concomitant treatment for their cancer
- Inability to provide full informed consent (e.g. due to dementia)
Key Trial Info
Start Date :
July 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04340245
Start Date
July 1 2020
End Date
December 1 2028
Last Update
February 26 2024
Active Locations (1)
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1
University College Hospital
London, United Kingdom