The GENPET Study - An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI pelvis or CT imaging under clinical management for Pr Ca, Whole body bone scan imaging, PET-CT imaging.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, BRCA Mutation, Mismatch Repair Gene Mutation, ATM Gene Mutation. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation (GENPET)
Overview
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.
Interventions
- Other MRI pelvis or CT imaging under clinical management for Pr Ca
Individuals to undergo a clinical MRI or CT scan of Pelvis and the study reviews the images. - Other Whole body bone scan imaging
bone scan of the whole body (under clinical diagnosis). - Other PET-CT imaging
Pt will undergo a PET-CT for their clinical treatment and we will review the images of this scan.
Primary outcome measures
- 1. Sensitivity of FCH-PET-CT scan [Time frame: Within 12 months of the last FCH-PET-CT scan]
Secondary outcome measures (3)
- 2. Outline the Specificity of the FCH-PET-CT scan [Time frame: Within 12 months of the last FCH-PET-CT scan]
- Metastasis Incidence [Time frame: Within 12 months of the last FCH-PET-CT scan]
- Impact of FCH-PET-CT findings [Time frame: Within 12 months of the last FCH-PET-CT scan]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United Kingdom · 1 center
- Cancer Genetics Unit, Royal Marsden Hospital — London
Identifiers
NCT: NCT05097274 · CCR4131