Prostate Cancer Clinical Trial
— GENPROSOfficial title:
Analysing Outcomes After Prostate Cancer Diagnosis and Treatment in Carriers of Rare Germline Mutation in Cancer Predisposition Genes
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.
Status | Recruiting |
Enrollment | 4260 |
Est. completion date | December 2035 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Institute of Cancer Research and Royal Marsden Hospital | Sutton | Surrey |
Lead Sponsor | Collaborator |
---|---|
Institute of Cancer Research, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 60 months | |
Secondary | 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 | 60 months | |
Secondary | 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 | 60 months | |
Secondary | 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 | 60 months |
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