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

Sponsor: Institute of Cancer Research, United Kingdom

NCT ID: NCT05097274

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
MRI pelvis or CT imaging under clinical management for Pr Ca (other), Whole body bone scan imaging (other), PET-CT imaging (other)
How long the study runs
Study runs about 206 months (dates as stated)
About the drug or intervention
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. · Whole body bone scan imaging — other: bone scan of the whole body (under clinical diagnosis). · PET-CT imaging — other: Pt will undergo a PET-CT for their clinical treatment and we will review the images of this scan.
Patient visit burden
Not specified by the sponsor

In plain English

This study is looking at a type of scan called FCH PET-CT in men with prostate cancer who also have an inherited change (mutation) in a DNA repair gene, such as BRCA1, BRCA2, ATM or CHEK2. The study wants to see how well this scan shows prostate cancer. It is run by the Institute of Cancer Research in the United Kingdom.

Who can take part

  • Men over 18 with prostate cancer
  • A confirmed inherited (germline) mutation in one of these genes: BRCA1, BRCA2, MSH2, MSH6, MLH1, PMS2, CHEK2, PALB2 or ATM
  • Needing a staging scan, either at new diagnosis, after previous surgery or radiotherapy (more than 6 months ago) with rising PSA and no current hormone treatment or chemotherapy, or on active surveillance with a PSA doubling time of 6 months or less

Who may not be able to

  • Another cancer in the last 5 years (apart from certain skin cancers)
  • Prostate cancer that has already spread
  • Any cancer treatment in the last 6 months
  • Taking part in another drug trial
  • Taking steroids
  • A history of inflammatory or infective diseases, such as sarcoidosis, tuberculosis or inflammatory bowel disease
  • Anything that makes an MRI unsafe, such as a pacemaker, aneurysm clips or severe claustrophobia

What taking part involves

  • • Having an FCH PET-CT scan
  • • Not stated — ask the trial team about any other tests or procedures

Time commitment: Not stated — ask the trial team how many visits are needed, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
Male
Number of participants
50
Started
2015-10-15
Last checked
2025-12

Plain English Summary

What is this study?

  • • Testing a new treatment for prostate cancer
  • • Clinical study - 50 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with prostate cancer
  • • Male only

Where?

  • • London - Cancer Genetics Unit, Royal Marsden Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Prostate CancerBRCA MutationMismatch Repair Gene MutationATM Gene MutationHOXB13 Germline MutationCHEK2 Gene MutationPALB2 Gene Mutation

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Male only

Biomarkers mentioned

BRCA1BRCA2PSA

What the study is looking for

  • ✓Confirmed pathogenic germline mutation in any of the following genes BRCA1, BRCA2, MSH2, MSH6, MLH1, PMS2, CHEK2,...
  • ✓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)...

Who cannot take part

  • ✗Diagnosis of other cancer (excluding basal cell cancer/squamous cell cancer of the skin) within five years of...
  • ✗Known that has spread 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
See the full criteria
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)

Where Is This Study? (1 UK site)

Cancer Genetics Unit, Royal Marsden Hospital

London SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Rosalind Eeles, MA; PhD; FRCP; FRCR; FMedSci44 208 661 3642rosalind.eeles@icr.ac.uk

How to Get in Touch

Rosalind A Eeles, FRCP FRCR

Sponsor contact

CONTACT

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

Elizabeth K Bancroft, PhD

Sponsor contact

CONTACT

+44 208 722 4483 elizabeth.bancroft@rmh.nhs.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-12