RecruitingRecruiting
The GENPET Study - An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation.
NCT05097274 · Institute of Cancer Research, United Kingdom
In plain English
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Official title
An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation (GENPET)
About this study
The aim of the study is to determine if PET-CT imaging (using contrast recommended in clinical guidelines) is superior to combined bone scan and MRI/CT of the abdomen \& pelvis in detecting the increased incidence of metastasis (nodal/distant outside the pelvis) in men with prostatic carcinoma with mutations in any of the following germline DNA repair genes BRCA1, BRCA2, MSH2, MSH6, MLH1, PMS2, CHEK2, PALB2, ATM.
Eligibility 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)
Study design
Enrollment target: 50 participants
Age groups: adult, older_adult
Timeline
Starts: 2015-10-15
Estimated completion: 2032-12-31
Last updated: 2025-12-16
Interventions
Other: MRI pelvis or CT imaging under clinical management for Pr CaOther: Whole body bone scan imagingOther: PET-CT imaging
Primary outcomes
- • 1. Sensitivity of FCH-PET-CT scan (Within 12 months of the last FCH-PET-CT scan)
Sponsor
Institute of Cancer Research, United Kingdom · other
With: Cancer Research UK, National Institute for Health Research, United Kingdom
Contacts & investigators
ContactRosalind A Eeles, FRCP FRCR · contact · rosalind.eeles@icr.ac.uk · +44 208 722 4483
ContactElizabeth K Bancroft, PhD · contact · elizabeth.bancroft@rmh.nhs.uk · +44 208 722 4483
InvestigatorRosalind A Eeles, FRCP FRCR · principal_investigator, Institute of Cancer Research and Royal Marsden Hospital
All locations (1)
Cancer Genetics Unit, Royal Marsden HospitalRecruiting
London, Sutton, Surrey, United Kingdom