Prostate CancerGENPETNCT05097274
The GENPET Study - An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation.
An observational study of Prostate Cancer and BRCA Mutation, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, BRCA Mutation, Mismatch Repair Gene Mutation
- What is being tested?
- MRI pelvis or CT imaging under clinical management for Pr Ca, Whole body bone scan imaging and PET-CT imaging
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2015to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Any patient that meets the eligibility criteria and a patient at the Royal Marsden Hospital.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Cancer Genetics Unit, Royal Marsden Hospital
London, Sutton, Surrey, SM2 5PT
Rosalind Eeles, MA; PhD; FRCP; FRCR; FMedSci, 44 208 661 3642, rosalind.eeles@icr.ac.uk
Elizabeth K Bancroft, PhD, 44 207 808 2136, elizabeth.bancroft@icr.ac.uk
About this study
Official title: 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.
- Conditions
- Prostate Cancer, BRCA Mutation, Mismatch Repair Gene Mutation, ATM Gene Mutation, HOXB13 Germline Mutation, CHEK2 Gene Mutation
- Being tested
- MRI pelvis or CT imaging under clinical management for Pr Ca, Whole body bone scan imaging, PET-CT imaging
- Keywords
- FCH-PET-CT, PSMA-PET-CT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI pelvis or CT imaging under clinical management for Pr CaOther
Also called Magnetic resonance imaging or computerized axial tomography
Individuals to undergo a clinical MRI or CT scan of Pelvis and the study reviews the images.
Whole body bone scan imagingOther
Also called Bone scintigraphy
bone scan of the whole body (under clinical diagnosis).
PET-CT imagingOther
Pt will undergo a PET-CT for their clinical treatment and we will review the images of this scan.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: MRI pelvis or CT imaging under clinical management for Pr Ca; Other: Whole body bone scan imaging; Other: PET-CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 months of the last FCH-PET-CT scan
Secondary outcomes (3)
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
Measured: 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.
Measured: 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
Measured: Within 12 months of the last FCH-PET-CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start15 Oct 2015
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Rosalind A Eeles, FRCP FRCR, Principal investigator, Institute of Cancer Research and Royal Marsden Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097274
- Sponsor's protocol ID
- CCR4131
- Acronym
- GENPET
- Status last verified
- Dec 2025
- First submitted
- 15 Oct 2021
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised data may be applied for via the Study Team
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation (GENPET)
- ClinicalTrials.gov ID
- NCT05097274
- Acronym / sponsor ID
- GENPET / CCR4131
- Conditions
- Prostate Cancer, BRCA Mutation, Mismatch Repair Gene Mutation, ATM Gene Mutation, HOXB13 Germline Mutation, CHEK2 Gene Mutation
- Keywords
- FCH-PET-CT, PSMA-PET-CT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Cancer Research UK, National Institute for Health Research, United Kingdom
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DNA repair gene mutation carriers | – | Other: MRI pelvis or CT imaging under clinical management for Pr Ca, Other: Whole body bone scan imaging, Other: PET-CT imaging* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient that meets the eligibility criteria and a patient at the Royal Marsden Hospital.
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI pelvis or CT imaging under clinical management for Pr CaAlso: Magnetic resonance imaging or computerized axial tomographyIndividuals to undergo a clinical MRI or CT scan of Pelvis and the study reviews the images. | Other | DNA repair gene mutation carriers |
| Whole body bone scan imagingAlso: Bone scintigraphybone scan of the whole body (under clinical diagnosis). | Other | DNA repair gene mutation carriers |
| PET-CT imagingPt will undergo a PET-CT for their clinical treatment and we will review the images of this scan. | Other | DNA repair gene mutation carriers |
Primary outcome
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.
3 secondary outcomes
2. Outline the Specificity of the FCH-PET-CT scan
Time frame: Within 12 months of the last FCH-PET-CT scan
Metastasis Incidence
Time frame: Within 12 months of the last FCH-PET-CT scan
Impact of FCH-PET-CT findings
Time frame: Within 12 months of the last FCH-PET-CT scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: Undecided. Anonymised data may be applied for via the Study Team
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rosalind A Eeles, FRCP FRCR principal investigator
Institute of Cancer Research and Royal Marsden Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and BRCA Mutation, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosalind A Eeles, FRCP FRCR (+44 208 722 4483, rosalind.eeles@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Sensitivity of FCH-PET-CT scan (time frame: Within 12 months of the last FCH-PET-CT scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.