The GENPET Study - An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a BRCA Gene Mutation.

Study Overview
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Brief Summary
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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 germline BRCA mutations.

Official Title
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An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a BRCA Gene Mutation (GENPET)

Conditions
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Prostate Cancer, BRCA1 Mutation, BRCA2 Mutation

Intervention / Treatment
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* Other: MRI pelvis or CT imaging under clinical management for Pr Ca
* Other: Whole body bone scan imaging
* Other: PET-CT imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed pathogenic germline mutation in either BRCA1 or BRCA2 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BRCA mutation carriers<br>Newly diagnosed with prostate cancer (any Gleason score, any stage, any PSA) 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 | Other: MRI pelvis or CT imaging under clinical management for Pr Ca<br>* Individuals to undergo a clinical MRI or CT scan of Pelvis and the study reviews the images.<br>* Other names: Magnetic resonance imaging or computerized axial tomography;Other: Whole body bone scan imaging<br>* bone scan of the whole body (under clinical diagnosis).<br>* Other names: Bone scintigraphy;Other: PET-CT imaging<br>* Pt will undergo a PET-CT for their clinical treatment and we will review the images of this scan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 12 months of the last FCH-PET-CT scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. |  | Within 12 months of the last FCH-PET-CT scan | 
| 4.To measure the impact of FCH-PET-CT findings in changing patient management and in clinical decision making |  | Within 12 months of the last FCH-PET-CT scan | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FCH-PET-CT