The GENPET Study - An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation.
Recruiting now
Conditions studied: Prostate Cancer, BRCA Mutation, Mismatch Repair Gene Mutation, ATM Gene Mutation, HOXB13 Germline Mutation, CHEK2 Gene Mutation, PALB2 Gene Mutation
In brief
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.
Key facts
- Study ID
- NCT05097274
- Run by
- Institute of Cancer Research, United Kingdom
- People needed
- 50
- Starts
- 2015-10-15
- Expected to finish
- 2032-12-31
- Last updated by the study team
- 2025-12-16
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Cancer Genetics Unit, Royal Marsden Hospital — London, Sutton, Surrey, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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