Imaging study using FCH-PET-CT in men with prostate cancer and DNA repair gene mutations
Official title: An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation (GENPET)
Run by Institute of Cancer Research, United Kingdom · NCT05097274 · Data updated 2026-11-12
This study is testing if a new type of imaging called FCH-PET-CT can better find cancer spread in men with prostate cancer who have certain gene mutations compared to regular imaging methods.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 50 (estimated) |
| Sponsor | Institute of Cancer Research, United Kingdom Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (London, Sutton, Surrey) |
| Status | Recruiting |
| Started | October 15, 2015 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2032 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT05097274 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include men over 18 with prostate cancer and confirmed pathogenic mutations in specific DNA repair genes.
✕Probably not a fit
Patients with known metastatic prostate cancer or those who have received recent oncological treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the effectiveness of FCH-PET-CT imaging compared to traditional imaging methods like bone scans and MRI/CT in detecting metastasis in men diagnosed with prostate cancer who have specific germline DNA repair gene mutations. The study focuses on patients with mutations in genes such as BRCA1, BRCA2, and ATM, among others. Participants will undergo imaging procedures as part of their clinical management to assess the incidence of metastasis outside the pelvis. The goal is to determine if FCH-PET-CT provides superior detection capabilities for these patients.
Why it matters
Potential benefit: If successful, this study could lead to improved detection of metastasis in prostate cancer patients with specific genetic mutations, potentially guiding more effective treatment strategies.
How similar studies have gone: Other studies have shown promising results with advanced imaging techniques in similar patient populations, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed pathogenic germline mutation in any of the following genes BRCA1, BRCA2, MSH2, MSH6, MLH1, PMS2, CHEK2, PALB2 or ATM. * Over the age of 18 * Diagnosed with prostate cancer and at a time when staging imaging is clinically indicated; either: * At a new diagnosis * Biochemically progressing patients who were treated radically with surgery or radiotherapy (more than 6 months ago) and are currently not receiving hormonal treatment or chemotherapy * Patients on active surveillance with a PSA doubling time of 6 months or less Exclusion Criteria: * Diagnosis of other malignancy (excluding basal cell cancer/squamous cell cancer of the skin) within five years of diagnosis * Known metastatic prostate cancer, both local and distant * Patients who have received any oncological treatment within the last six months * Patients on any investigational drug treatment * Patients on steroids * Known history of inflammatory/infective diseases (e.g. sarcoidosis, tuberculosis, inflammatory bowel disease) * Contraindications to having an MRI using the standard MRI checklist (e.g. pacemakers, aneurysm clips, claustrophobia)
Where it's running
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Cancer Genetics Unit, Royal Marsden Hospital
London, Sutton, Surrey, United Kingdom Recruiting
Study contacts
- Principal investigator: Rosalind A Eeles, FRCP FRCR — Institute of Cancer Research and Royal Marsden Hospital
- Study coordinator: Rosalind A Eeles, FRCP FRCR
- Email: rosalind.eeles@icr.ac.uk
- Phone: +44 208 722 4483
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.