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.
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
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
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
Any patient that meets the eligibility criteria and a patient at the Royal Marsden Hospital.
Case-only
Prospective
MRI pelvis or CT imaging under clinical management for Pr Ca
Other interventionIndividuals to undergo a clinical MRI or CT scan of Pelvis and the study reviews the images.
Whole body bone scan imaging
Other interventionbone scan of the whole body (under clinical diagnosis).
PET-CT imaging
Other interventionPt will undergo a PET-CT for their clinical treatment and we will review the images of this scan.
1. Sensitivity of 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.
2. Outline the Specificity of the 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
3.Incidence and sites of additional metastases identified on FCH-PET-CT compared with combined MRI/bone scan.
Impact of FCH-PET-CT findings
To measure the impact of FCH-PET-CT findings in changing patient management and in clinical decision making
Incidental second primary tumours
To investigate the rate of incidentally detected second primary tumours in BRCA mutation carriers with prostate cancer
Prognostic significance of FCH-PET-CT findings
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)
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Institute of Cancer Research, United Kingdom
Lead sponsor
Cancer Research UK
Collaborator
National Institute for Health Research, United Kingdom
Collaborator
