ATM Gene Mutation, BRCA Mutation, CHEK2 Gene Mutation, HOXB13 Germline Mutation, Mismatch Repair Gene Mutation, PALB2 Gene Mutation, Prostate Cancer
Conditions
Keywords
FCH-PET-CT, PSMA-PET-CT
Brief 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.
Interventions
OTHERPET-CT imaging
Pt will undergo a PET-CT for their clinical treatment and we will review the images of this scan.
OTHERMRI 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.
OTHERWhole body bone scan imaging
bone scan of the whole body (under clinical diagnosis).
Sponsors
Cancer Research UK
National Institute for Health Research, United Kingdom
Institute of Cancer Research, United Kingdom
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Sensitivity of FCH-PET-CT scan | Within 12 months of the last FCH-PET-CT scan | To determine if the sensitivity of FCH-PET-CT is superior to combined conventional imaging (MRI (T2 and T1 weighted)/CT and bone scan) in detecting nodal and distant (outside the pelvis) metastases in BRCA1/2 germline mutation carriers with prostate cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2. Outline the Specificity of the FCH-PET-CT scan | Within 12 months of the last FCH-PET-CT scan | determining the positive predictive value (PPV) and negative predictive value (NPV) in detecting metastatic disease in BRCA mutation carriers with prostate cancer |
| Metastasis Incidence | Within 12 months of the last FCH-PET-CT scan | 3.Incidence and sites of additional metastases identified on FCH-PET-CT compared with combined MRI/bone scan. |
| Impact of FCH-PET-CT findings | Within 12 months of the last FCH-PET-CT scan | To measure the impact of FCH-PET-CT findings in changing patient management and in clinical decision making |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidental second primary tumours | Within 12 months of the last FCH-PET-CT scan | To investigate the rate of incidentally detected second primary tumours in BRCA mutation carriers with prostate cancer |
| Prognostic significance of FCH-PET-CT findings | Within 12 months of the last FCH-PET-CT scan | To investigate the prognostic significance of FCH-PET-CT findings (e.g. employing standard SUV parameters and heterogeneity of PET texture of the primary prostate tumour) |
Countries
United Kingdom
Contacts
Primary ContactRosalind A Eeles, FRCP FRCR
Backup ContactElizabeth K Bancroft, PhD
Outcome results
None listed