An observational study in Prostate Cancer, sponsored by University College, London. Active, not recruiting at 1 site in United Kingdom. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-26.
Sponsored by University College, London · Observational
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 60 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Men over the age of 18 with prostate cancer (Gleason 3+4) who are on active surveillance.
Exclusion Criteria:
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.
Proportion
Proportion of concordant pairs molecular progressor- radiological progressor.
Time frame: 12 months
Progression time
Time to radiological progression
Time frame: 12 months
Lesion imaging characteristics
Quantitative and qualitative imaging characteristics of MRI lesions
Time frame: 12 months
Prostate imaging changes - quantitative
Quantitative imaging features (MRI and derivative) of MRI lesions(s), a radiological progression ring (if present) and the rest of the prostate at different time points
Time frame: 12 months
Prostate imaging changes - qualitative
Qualitative imaging features (MRI and derivative) of MRI lesion(s), a radiological progression ring (if present) and the rest of the prostate at different time points.
Time frame: 12 months
Imaging characteristics comparison
Quantitative imaging characteristics of MRI lesion(s), a radiological progression ring (if present) and the rest of the prostate at different time points and stratify by radiological progressors vs non progressors.
Time frame: 12 months
Histology
Qualitative and quantitative histologic composition of cancer and surrounding tissues
Time frame: 12 months
Heterogeneity
Histologic heterogeneity of cancer, both qualitatively and quantitatively
Time frame: 12 months
Molecular index
Molecular Index of cancer, peritumoral and normal tissue.
Time frame: 12 months
Urine and semen biomarkers
Next generation sequencing will be used to perform urinary and seminal genome, exosome, methylome and transcriptome analysis in order to identify novel molecular signatures associated with prostate cancer imaging endotypes. No commercial biomarkers will be assessed within this study. Biomarker definition (NIH NCI dictionary) A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. Also called molecular marker and signature molecule.
Time frame: 12 months
Inflammatory infiltrate
Qualitative and quantitative analysis of inflammatory infiltrate in cancer, peritumoral and normal tissue.
Time frame: 12 months
Blood biomarkers
Deep sequencing of circulating plasma DNA will be be used to explore novel prostate cancer biomarkers. Analysis of circulating inflammatory and immune markers including T-cell analysis will be used to correlate immunological biomarkers with prostate cancer endotypes.
Time frame: 12 months
Immune pathways
Qualitative and quantitative analysis of immune related pathways
Time frame: 12 months
Transition to active treatment
Proportion of patients who transition to active treatment, by time and type of treatment.
Time frame: 12 months
Treatment eligibility
Proportion of patients eligible to a type of treatment at baseline and follow-up.
Time frame: 12 months
Rate of metastasis
Rate of metastasis for prostate cancer at different time point.
Time frame: 12 months
Concordance, histology and imaging
Concordance rate between progression at histology and imaging.
Time frame: 12 months
Concordance, radiology
Concordance rate between radiologist for PRECISE scoring.
Time frame: 12 months
Patient reported outcomes - EPIC 26
Patient reported outcomes at different time points using the RPIC 26 questionnaire
Time frame: 12 months
Patient reported outcomes - EORTC-QLQ-C30
Patient reported outcomes at different time points using the EORTC-QLQ-C30 questionnaire
Time frame: 12 months
Patient reported outcomes - MAX-PC
Patient reported outcomes at different time points using the MAX-PC questionnaire
Time frame: 12 months
Plan to share: No — No individual participant data will be shared. Patients will be identified by a pseudo-anonymised patient number
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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University College, London