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NCT Number: NCT05097274

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

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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Key information

Conditions

Prostate Cancer ATM Gene Mutation BRCA Mutation CHEK2 Gene Mutation Genital Diseases Genital Diseases, Male Genital Neoplasms, Male HOXB13 Germline Mutation Male Urogenital Diseases Mismatch Repair Gene Mutation Neoplasms Neoplasms by Site PALB2 Gene Mutation Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Magnetic resonance imaging or computerized axial tomography

Whole body bone scan imaging

Other

bone scan of the whole body (under clinical diagnosis).

Other names: Bone scintigraphy

PET-CT imaging

Other

Pt will undergo a PET-CT for their clinical treatment and we will review the images of this scan.

Primary outcomes

  1. 1. Sensitivity of FCH-PET-CT scan

    Time frame: Within 12 months of the last 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.

Secondary outcomes

  1. 2. Outline the Specificity of the FCH-PET-CT scan

    Time frame: Within 12 months of the last 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

  2. Metastasis Incidence

    Time frame: Within 12 months of the last FCH-PET-CT scan

    3.Incidence and sites of additional metastases identified on FCH-PET-CT compared with combined MRI/bone scan.

  3. Impact of FCH-PET-CT findings

    Time frame: Within 12 months of the last FCH-PET-CT scan

    To measure the impact of FCH-PET-CT findings in changing patient management and in clinical decision making

Other outcomes

  1. Incidental second primary tumours

    Time frame: Within 12 months of the last FCH-PET-CT scan

    To investigate the rate of incidentally detected second primary tumours in BRCA mutation carriers with prostate cancer

  2. Prognostic significance of FCH-PET-CT findings

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth K Bancroft, PhD

CONTACT

[email protected]

+44 208 722 4483

Rosalind A Eeles, FRCP FRCR

CONTACT

[email protected]

+44 208 722 4483

Sponsors and collaborators

Lead sponsor

Institute of Cancer Research, United Kingdom

Other

Collaborators

  • Cancer Research UK
  • National Institute for Health Research, United Kingdom

Registry information

Official study title

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

Acronym: GENPET

Important dates

Study start
2015
Primary completion
2027
Study completion
2032
First posted
Oct 28, 2021
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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