NCT05097274 The GENPET Study - An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation.
| NCT ID | NCT05097274 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Cancer Research, United Kingdom |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2015-10-15 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2015-10-15 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 the following germline DNA repair genes BRCA1, BRCA2, MSH2, MSH6, MLH1, PMS2, CHEK2, PALB2, ATM.
Eligibility 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)
Contact & Investigator
Rosalind A Eeles, FRCP FRCR
PRINCIPAL INVESTIGATOR
Institute of Cancer Research and Royal Marsden Hospital
Frequently Asked Questions
Who can join the NCT05097274 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05097274 currently recruiting?
Yes, NCT05097274 is actively recruiting participants. Contact the research team at rosalind.eeles@icr.ac.uk for enrollment information.
Where is the NCT05097274 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT05097274 clinical trial?
NCT05097274 is sponsored by Institute of Cancer Research, United Kingdom. The principal investigator is Rosalind A Eeles, FRCP FRCR at Institute of Cancer Research and Royal Marsden Hospital. The trial plans to enroll 50 participants.
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