NCT04340245

Exploiting Risk-Based Risk Stratification in Early Prostate Cancer to Discriminate Progressors From Non-Progressors

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: —

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 and transcriptomic differences between cancers that progress and cancers which do not.

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 to the study. They will undergo blinded, concurrent molecular and radiological analysis of their cancer at baseline and at one year. Tests at baseline and one year will include mpMRI, targeted prostate biopsy and further tissue sampling (semen, urine and blood). There will be PSA monitoring at 3 monthly intervals throughout the study as per standard of care active surveillance. Tissue will be analysed for biological and molecular markers significantly associated with radiological progression events. After consenting to taking part in the study a patient will come in for an MRI scan as standard of care. This scan will be used at a subsequent visit to inform a guided trans-perineal biopsy. At this biopsy visit patients will provide research blood samples, a urine sample and have a confirmatory biopsy. After the standard of care diagnostic tissue samples are taken, three research tissue samples will be taken. If the patient has been identified through the ReIMAGINE study and consents to take part in RECONCILE then these baseline visits are not needed, the data from ReIMAGINE will be used as the baseline visit data. The patient will come in as scheduled for their regular PSA visits in line with their active surveillance protocol. If a PSA test shows signs of potential progression the patient will have a standard of care diagnostic MRI, if this confirms progression then the imaging and biopsy visits scheduled for one year will be triggered early. In the absence of any identified progression the patient will return after 12 months and have both the imaging and biopsy visits repeated (again providing blood and urine). After this visit the patient will be considered as having finished the study. Patients who consent to take part in the study who have previously taken part in the PLiS semen donation study will be asked to provide a semen sample before the one year biopsy visit for comparison with the baseline sample that was provided for the PLiS study.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	NA (Observational)	No interventions will be carried out. Comparisons will be made between patients whose cancer has progressed over the course of one year and patients whose cancer hasn't.

Timeline

• Start date: 2020-07-01
• Primary completion: 2024-03-30
• Completion: 2028-12-01
• First posted: 2020-04-09
• Last updated: 2024-02-26

Locations

1 site across 1 country: United Kingdom