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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorInstitute of Cancer Research, United Kingdom

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • MRI pelvis or CT imaging under clinical management for Pr Ca
  • Whole body bone scan imaging
  • PET-CT imaging

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Institute of Cancer Research, United Kingdom

Lead sponsor

Cancer Research UK

Collaborator

National Institute for Health Research, United Kingdom

Collaborator