Clinical trial NCT05097274: The GENPET Study - An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation.
Official title: An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation (GENPET)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
BRCA Mutation
Mismatch Repair Gene Mutation
ATM Gene Mutation
HOXB13 Germline Mutation
CHEK2 Gene Mutation
PALB2 Gene Mutation
Keywords: FCH-PET-CT
PSMA-PET-CT
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
name: National Institute for Health Research, United Kingdom
First posted: 2021-10-28
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient that meets the eligibility criteria and a patient at the Royal Marsden Hospital.

Brief 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 criteria: 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)

Primary outcomes:
measure: 1. Sensitivity of FCH-PET-CT scan
timeFrame: Within 12 months of the last FCH-PET-CT scan
Secondary outcomes:
measure: 2. Outline the Specificity of the FCH-PET-CT scan
timeFrame: Within 12 months of the last FCH-PET-CT scan
measure: Metastasis Incidence
timeFrame: Within 12 months of the last FCH-PET-CT scan
measure: Impact of FCH-PET-CT findings
timeFrame: Within 12 months of the last FCH-PET-CT scan
Other outcomes:
measure: Incidental second primary tumours
timeFrame: Within 12 months of the last FCH-PET-CT scan
measure: Prognostic significance of FCH-PET-CT findings
timeFrame: Within 12 months of the last FCH-PET-CT scan
Locations:
city: London
country: United Kingdom
facility: Cancer Genetics Unit, Royal Marsden Hospital
state: Sutton, Surrey
Study officials:
affiliation: Institute of Cancer Research and Royal Marsden Hospital
name: Rosalind A Eeles, FRCP FRCR
role: PRINCIPAL_INVESTIGATOR
References: