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

NCT ID: NCT05097274

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-15

Study Completion Date

2032-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

MRI pelvis or CT imaging under clinical management for Pr Ca

Intervention Type OTHER

Individuals to undergo a clinical MRI or CT scan of Pelvis and the study reviews the images.

Whole body bone scan imaging

Intervention Type OTHER

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

PET-CT imaging

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Whole body bone scan imaging

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

Intervention Type OTHER

PET-CT imaging

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

Intervention Type OTHER

Other Intervention Names

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Magnetic resonance imaging or computerized axial tomography Bone scintigraphy

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cancer Research UK

OTHER

Sponsor Role collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rosalind A Eeles, FRCP FRCR

Role: PRINCIPAL_INVESTIGATOR

Institute of Cancer Research and Royal Marsden Hospital

Locations

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Cancer Genetics Unit, Royal Marsden Hospital

London, Sutton, Surrey, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Rosalind A Eeles, FRCP FRCR

Role: CONTACT

+44 208 722 4483

Elizabeth K Bancroft, PhD

Role: CONTACT

+44 208 722 4483

Facility Contacts

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Rosalind Eeles, MA; PhD; FRCP; FRCR; FMedSci

Role: primary

44 208 661 3642

Elizabeth K Bancroft, PhD

Role: backup

44 207 808 2136

Other Identifiers

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CCR4131

Identifier Type: -

Identifier Source: org_study_id