Clinical trial · Observational
Analysing Outcomes After Prostate Cancer Diagnosis and Treatment in Carriers of Rare Germline Mutations
Analysing Outcomes After Prostate Cancer Diagnosis and Treatment in Carriers of Rare Germline Mutation in Cancer Predisposition Genes
- 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)
GENPROS aims to analyse the outcomes of patients with rare gene mutations in the cancer predisposition genes, BRCA1, BRCA2, HOXB13, and Lynch Syndrome, after a diagnosis of and treatment for prostate cancer (PCa). The study includes a cohort of gene mutation carriers with PCa matched with a control group of men with PCa who are known not to carry a mutation in the same gene. Clinical data regarding treatment and patient outcome will be collected retrospectively and prospectively. Archived tumour samples will also be collected for tumour profiling. A blood or saliva sample will be taken, if the participant consents to this part of the study, for genetic profiling to investigate any association of other inherited factors with PCa outcomes. Information obtained from this study will be of critical importance to support clinical trials investigating the most appropriate management of PCa in this group of patients at increased risk of prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation of treatment outcomes via Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Mutation carriers with Prostate cancer
- description
- Men with prostate cancer and a known pathogenic germline mutation in: 1. the BRCA1 or BRCA2 gene 2. the HOXB13 gene 3. The MSH2 gene 4. All other Lynch Syndrome genes (MLH1, MSH6, PMS2, EPCAM) 5. The ATM gene 6. Other PCa predisposition genes
- interventionNames
- Other: Observation of treatment outcomes via Questionnaire
- label
- Mutation non carriers
- description
- Men with prostate cancer who have tested negative for a mutation in one of the following genes: 1. the BRCA1 or BRCA2 gene 2. the HOXB13 gene 3. The MSH2 gene 4. All other Lynch Syndrome genes (MLH1, MSH6, PMS2, EPCAM) 5. The ATM gene 6. Other PCa predisposition genes
- interventionNames
- Other: Observation of treatment outcomes via Questionnaire
Primary outcomes (1)
- measure
- Cause Specific Survival (CSS) will be measured in men with prostate cancer who carry a rare germline mutation and compared to CSS in non-carriers
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men diagnosed with PCa are eligible if: * known carriers of germline mutations associated with PCa risk OR * known non-carriers of mutations in the genes above Exclusion Criteria: * patients under 18 years of age * patients who are unable to give informed consent * patients who cannot be traced (\<6 months follow-up) or whose clinical data are not available * patients whose genetic status is unknown
References
Publications (0)
Data not yet available