About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
known carriers of germline mutations associated with PCa risk OR
known non-carriers of mutations in the genes above
Disqualifiers
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
Trial population
The study includes a cohort of rare gene mutation carriers with PCa and a control group formed of PCa patients known not to carry mutations in the same genes for comparison.
Trial design
Case-control
Prospective
Treatments tested in this trial
Observation of treatment outcomes via Questionnaire
Other interventionCollection of treatment data from participants
Treatment groups
Trial outcomes
Primary outcomes
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
Survival will be calculated from the date of PCa diagnosis until date of death from any cause or censored at the last follow-up
Secondary outcomes
Biochemical progression free survival (bPFS) will be measured and compared between mutation carriers and non-carriers.
Survival will be calculated from the date of PCa diagnosis until date of death from any cause or censored at the last follow-up
Metastasis free survival (MFS) after radical treatment will be measured and compared between mutation carriers and non-carriers.
Survival will be calculated from the date of PCa diagnosis until date of death from any cause or censored at the last follow-up
Overall survival will be measured and compared between mutation carriers and non-carriers.
Survival will be calculated from the date of PCa diagnosis until date of death from any cause or censored at the last follow-up
Sponsors and contacts
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