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| Name | Class |
|---|---|
| Cancer Research UK | OTHER |
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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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 mutations in any of the following germline DNA repair genes BRCA1, BRCA2, MSH2, MSH6, MLH1, PMS2, CHEK2, PALB2, ATM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DNA repair gene mutation carriers |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI pelvis or CT imaging under clinical management for Pr Ca | Other | Individuals to undergo a clinical MRI or CT scan of Pelvis and the study reviews the images. |
|
| 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 |
| 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 |
| Metastasis Incidence |
| Measure | Description | Time Frame |
|---|---|---|
| Incidental second primary tumours | To investigate the rate of incidentally detected second primary tumours in BRCA mutation carriers with prostate cancer | Within 12 months of the last FCH-PET-CT scan |
| Prognostic significance of FCH-PET-CT findings |
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:
Exclusion Criteria:
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Any patient that meets the eligibility criteria and a patient at the Royal Marsden Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosalind A Eeles, FRCP FRCR | Contact | +44 208 722 4483 | rosalind.eeles@icr.ac.uk | |
| Elizabeth K Bancroft, PhD | Contact | +44 208 722 4483 | elizabeth.bancroft@rmh.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Rosalind A Eeles, FRCP FRCR | Institute of Cancer Research and Royal Marsden Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Genetics Unit, Royal Marsden Hospital | Recruiting | London | Sutton, Surrey | SM2 5PT | United Kingdom |
Anonymised data may be applied for via the Study Team
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|
| Whole body bone scan imaging | Other | bone scan of the whole body (under clinical diagnosis). |
|
|
| PET-CT imaging | Other | Pt will undergo a PET-CT for their clinical treatment and we will review the images of this 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 |
| Impact of FCH-PET-CT findings | 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 |
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)
| Within 12 months of the last FCH-PET-CT scan |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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