The GENPET Study - An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation.
An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation (GENPET)
Institute of Cancer Research, United Kingdom
50 participants
Oct 15, 2015
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria6
- 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 Criteria7
- 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)
Interventions
Individuals to undergo a clinical MRI or CT scan of Pelvis and the study reviews the images.
bone scan of the whole body (under clinical diagnosis).
Pt will undergo a PET-CT for their clinical treatment and we will review the images of this scan.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05097274