Clinical trial · Observational
The GENPET Study - An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation.
An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation (GENPET)
NCT05097274CI-TRIAL-00099042GENPETrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ATM Gene Mutation | — | UNRESOLVED | — |
| BRCA Mutation | — | UNRESOLVED | — |
| CHEK2 Gene Mutation | — | UNRESOLVED | — |
| HOXB13 Germline Mutation | — | UNRESOLVED | — |
| Mismatch Repair Gene Mutation | — | UNRESOLVED | — |
| PALB2 Gene Mutation | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI pelvis or CT imaging under clinical management for Pr Ca | Other | — | UNRESOLVED |
| PET-CT imaging | Other | — | UNRESOLVED |
| Whole body bone scan imaging | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- DNA repair gene mutation carriers
- description
- * 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
- interventionNames
- Other: MRI pelvis or CT imaging under clinical management for Pr Ca
- Other: Whole body bone scan imaging
- Other: PET-CT imaging
Primary outcomes (1)
- measure
- 1. Sensitivity of FCH-PET-CT scan
- timeFrame
- Within 12 months of the last FCH-PET-CT scan
- description
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.