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

April 24, 2024 updated by: Institute of Cancer Research, United Kingdom

An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a BRCA 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 germline BRCA mutations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Sutton, Surrey
      • London, Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • Cancer Genetics Unit, Royal Marsden Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 either BRCA1 or BRCA2
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BRCA 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
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.
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
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
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.
Time Frame: Within 12 months of the last FCH-PET-CT scan
Within 12 months of the last FCH-PET-CT scan
4.To measure the impact of FCH-PET-CT findings in changing patient management and in clinical decision making
Time Frame: Within 12 months of the last FCH-PET-CT scan
Within 12 months of the last FCH-PET-CT scan

Other Outcome Measures

Outcome Measure
Time Frame
To investigate the rate of incidentally detected second primary tumours in BRCA mutation carriers with prostate cancer
Time Frame: Within 12 months of the last FCH-PET-CT scan
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)
Time Frame: Within 12 months of the last FCH-PET-CT scan
Within 12 months of the last FCH-PET-CT scan
To assess agreement between imaging readers in assessing FCH-PET-CT scans.
Time Frame: Within 12 months of the last FCH-PET-CT scan
Within 12 months of the last FCH-PET-CT scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2015

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

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 (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on MRI pelvis or CT imaging under clinical management for Pr Ca

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe