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

RECRUITINGSponsored by Institute of Cancer Research, United Kingdom
Actively Recruiting
SponsorInstitute of Cancer Research, United Kingdom
Started2015-10-15
Est. completion2027-12-31
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted

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.

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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)

Conditions8

ATM Gene MutationBRCA MutationCHEK2 Gene MutationCancerHOXB13 Germline MutationMismatch Repair Gene MutationPALB2 Gene MutationProstate Cancer

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