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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    71
  • sponsor
    Institute of Cancer Research, United Kingdom
Updated on 25 April 2022

Summary

The aim of the study is to determine if FCH-PET-CT imaging 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.

Details
Condition Prostate Cancer, BRCA1 Mutation, BRCA2 Mutation
Treatment MRI pelvis or CT imaging, Whole body bone scan imaging, FCH-PET-CT imaging
Clinical Study IdentifierNCT05097274
SponsorInstitute of Cancer Research, United Kingdom
Last Modified on25 April 2022

Eligibility

Yes No Not Sure

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)
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