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

NCT05097274 | Recruiting

• 1 other identifier: CCR4131
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; BRCA Mutation; ATM Gene Mutation; HOXB13 Germline Mutation; CHEK2 Gene Mutation; PALB2 Gene Mutation; Mismatch Repair Gene Mutation

Keywords

FCH-PET-CT; PSMA-PET-CT

Outcome Measures

Primary Outcomes (1)

• 1. Sensitivity of 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.

  Within 12 months of the last FCH-PET-CT scan

Secondary Outcomes (3)

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

  Within 12 months of the last FCH-PET-CT scan

• Metastasis Incidence

  Within 12 months of the last FCH-PET-CT scan

• Impact of FCH-PET-CT findings

  Within 12 months of the last FCH-PET-CT scan

Other Outcomes (2)

• Incidental second primary tumours

  Within 12 months of the last FCH-PET-CT scan

• Prognostic significance of FCH-PET-CT findings

  Within 12 months of the last FCH-PET-CT scan

Study Arms (1)

DNA repair gene mutation carriers

* Newly diagnosed with prostate cancer (any Gleason score, any stage, any PSA) * 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

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

Interventions

Whole body bone scan imaging OTHER

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

Also known as: Bone scintigraphy

DNA repair gene mutation carriers

PET-CT imaging OTHER

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

DNA repair gene mutation carriers

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.

Also known as: Magnetic resonance imaging or computerized axial tomography

DNA repair gene mutation carriers

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient that meets the eligibility criteria and a patient at the Royal Marsden Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cancer Research UK: collaborator
• National Institute for Health Research, United Kingdom: collaborator
• Institute of Cancer Research, United Kingdom: lead

Study Sites (1)

Cancer Genetics Unit, Royal Marsden Hospital

London, Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Rosalind A Eeles, FRCP FRCR

  Institute of Cancer Research and Royal Marsden Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosalind A Eeles, FRCP FRCR

CONTACT

+44 208 722 4483; rosalind.eeles@icr.ac.uk

Elizabeth K Bancroft, PhD

CONTACT

+44 208 722 4483; elizabeth.bancroft@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 28, 2021
• Study Start: October 15, 2015
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

GB (1)