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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; PALB2 Gene Mutation; ATM Gene Mutation; CHEK2 Gene Mutation; Mismatch Repair Gene Mutation; BRCA Mutation; HOXB13 Germline Mutation
• Intervention / Treatment: Other: MRI pelvis or CT imaging under clinical management for Pr Ca; Other: Whole body bone scan imaging; Other: PET-CT imaging

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Elizabeth K Bancroft, PhD; Phone Number: +44 208 722 4483; Email: elizabeth.bancroft@rmh.nhs.uk
• Study Contact Backup: Name: Rosalind A Eeles, FRCP FRCR; Phone Number: +44 208 722 4483; Email: rosalind.eeles@icr.ac.uk

Study Locations

• United Kingdom
  • Sutton, Surrey
    • London, Sutton, Surrey, United Kingdom, SM2 5PT
      • Recruiting
      • Cancer Genetics Unit, Royal Marsden Hospital
      • Contact: Elizabeth K Bancroft, PhD; Phone Number: 44 207 808 2136; Email: elizabeth.bancroft@icr.ac.uk
      • Contact: Rosalind Eeles, MA; PhD; FRCP; FRCR; FMedSci; Phone Number: 44 208 661 3642; Email: rosalind.eeles@icr.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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; Other: Whole body bone scan imaging; bone scan of the whole body (under clinical diagnosis).; Other Names: Bone scintigraphy; Other: PET-CT imaging; Pt will undergo a PET-CT for their clinical treatment and we will review the images of this scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
2. Outline the Specificity of the 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	Within 12 months of the last FCH-PET-CT scan
Metastasis Incidence	3.Incidence and sites of additional metastases identified on FCH-PET-CT compared with combined MRI/bone scan.	Within 12 months of the last FCH-PET-CT scan
Impact of FCH-PET-CT findings	To measure the impact of FCH-PET-CT findings in changing patient management and in clinical decision making	Within 12 months of the last FCH-PET-CT scan

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidental second primary tumours	To investigate the rate of incidentally detected second primary tumours in BRCA mutation carriers with prostate cancer	Within 12 months of the last FCH-PET-CT scan
Prognostic significance of FCH-PET-CT findings	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)	Within 12 months of the last FCH-PET-CT scan

Collaborators and Investigators

• Sponsor: Institute of Cancer Research, United Kingdom
• Collaborators: Cancer Research UK; National Institute for Health Research, United Kingdom
• Investigators: Principal Investigator: Rosalind A Eeles, FRCP FRCR, Institute of Cancer Research and Royal Marsden Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2015
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Estimated): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: FCH-PET-CT; PSMA-PET-CT
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Investigative Techniques; Chemistry Techniques, Analytical; Spectrum Analysis; Magnetic Resonance Spectroscopy
• Other Study ID Numbers: CCR4131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Anonymised data may be applied for via the Study Team

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No