Analysing Outcomes After Prostate Cancer Diagnosis and Treatment in Carriers of Rare Germline Mutations

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorInstitute of Cancer Research, United Kingdom

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Observation of treatment outcomes via Questionnaire

    Other intervention

    Collection of treatment data from participants

Treatment groups

4,260 Participants
are divided into 2 treatment groups
Group A: Mutation carriers with Prostate cancer1 intervention
Group B: Mutation non carriers1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
60 months

Secondary outcomes

1

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

Time frame
60 months
2

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

Time frame
60 months
3

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

Time frame
60 months

Other outcomes

Sponsors and contacts

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