Prostate cancer Cancer
Conditions
Interventions
Current methodology as of 08/07/2026:
This is a prospective cohort study in which we will ask men at high risk of prostate cancer or with a diagnosis of prostate cancer to donate blood, urine and tiss
Sponsors
Imperial College London
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Age 18 years or above (no upper limit) 2. Patients with a prostate (either cis-male gender or trans-female gender) 3. Undergoing diagnostic systematic biopsy +/- targeted biopsy for presumed high-risk prostate cancer on diagnostic imaging (MRI or ultrasound) 4. Patients with an existing histological diagnosis of locally advanced and/or metastatic prostate cancer at any point in their treatment pathway
Exclusion criteria
Exclusion criteria: 1. Patients unable to understand the Patient Information Sheet and unable to provide Informed Consent 2. For group 3, we will exclude men who have a diagnosis of immunosuppression or are on drugs that cause immunosuppression. We will also exclude men who have a higher than normal risk of bleeding such as those with bleeding disorders or drugs that thin the blood.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Characterisation of how the primary tumour impacts the metastatic niche using circulating factors, and how the metastatic niche impacts cancer outcomes through its interactions with metastatic cancer cells. This characterisation is via identification and measurement of cfDNA and miRNA in patient blood samples. Levels of both cfDNA and miRNA will be assessed in blood samples from before treatment and post-treatment (1 year), and will be related to treatment responses. 2. Characterisation of the (epi)genomic and transcriptomic profiles of primary and metastatic tumours and determine whether treating the primary tumour with radiotherapy, surgery or ablation reduces or alters ongoing seeding of metastases and manifests as a reduction in circulating tumour-derived material. This characterisation will occur using the frozen tumour sample material. The transcriptomic profile is created from gene expression data created via RNA-seq. The epigenomic profile is created from ATAC-seq. Both transcriptional and epigenomic profiles will be assessed in relation to clinical parameters and treatment outcomes. This will be assessed at the time of enrolment with the initial tissue sample. 3. An evaluation of the immune response, and its impact on local disease and metastases, that occurs following treatment of the primary tumour with radiotherapy, surgery or ablation. Immune characterisation will be based on immune signatures identified in RNA-seq data of frozen tissue, and measurement of protein identifiers of immune cells in formalin-fixed patient material via immunohistochemistry. Levels of identified immune cells will be measured for association with disease stage and response to treatment. This will be assessed in frozen tumour samples and formalin fixed tissue provided at the time of enrolment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Identification and adaptation of appropriate organoid models in which to functionally test and validate the above findings concerning the treatment of primary and metastatic tumours with systemic agents and radiotherapy | — |
Countries
England, United Kingdom
Outcome results
None listed