Imaging study using FCH-PET-CT in men with prostate cancer and DNA repair gene mutations
An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation (GENPET)
This study is testing if a new type of imaging called FCH-PET-CT can better find cancer spread in men with prostate cancer who have certain gene mutations compared to regular imaging methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Institute of Cancer Research, United Kingdom Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (London, Sutton, Surrey) |
| Trial ID | NCT05097274 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of FCH-PET-CT imaging compared to traditional imaging methods like bone scans and MRI/CT in detecting metastasis in men diagnosed with prostate cancer who have specific germline DNA repair gene mutations. The study focuses on patients with mutations in genes such as BRCA1, BRCA2, and ATM, among others. Participants will undergo imaging procedures as part of their clinical management to assess the incidence of metastasis outside the pelvis. The goal is to determine if FCH-PET-CT provides superior detection capabilities for these patients.
Who should consider this trial
Good fit: Ideal candidates include men over 18 with prostate cancer and confirmed pathogenic mutations in specific DNA repair genes.
Not a fit: Patients with known metastatic prostate cancer or those who have received recent oncological treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection of metastasis in prostate cancer patients with specific genetic mutations, potentially guiding more effective treatment strategies.
How similar studies have performed: Other studies have shown promising results with advanced imaging techniques in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 this trial is running
London, Sutton, Surrey
- Cancer Genetics Unit, Royal Marsden Hospital — London, Sutton, Surrey, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Rosalind A Eeles, FRCP FRCR — Institute of Cancer Research and Royal Marsden Hospital
- Study coordinator: Rosalind A Eeles, FRCP FRCR
- Email: rosalind.eeles@icr.ac.uk
- Phone: +44 208 722 4483
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.