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Not Yet Recruiting NCT05681416

Prostate Cancer Prevention Clinic for Men With Risk of Familial Prostate Cancer

Conditions: Prostate Cancer, Familial Prostate Cancer

Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 300
Sponsor: Heinrich-Heine University, Duesseldorf

Summary

Secondary prevention of prostate cancer (PCa) is not standardized and high-risk groups at the time of diagnosis are not well defined. Hereditary susceptibility which is reported in about 10% of men is one important risk factor for PCa development but the absolute risk and clinical importance is fairly unknown. The population risk for developing PCa is estimated to be 11%. If men carry a mutation in BRCA2 or HOXB13, the lifetime risk is 2 to 10-fold increased. "ProFam-Risk" is a prospective cohort analysis not only to validate the known genetic risk scores but also to establish recommendations for follow of high risk populations based on a combination of clinical parameters, imaging (magnetic resonance imaging of the prostate), and genetic profile. Aim of this individualized recommendation is on the one hand to early detect PCa before developing of advanced disease and on the other hand to counsel men at low risk in order to prevent overdiagnosis and overtreatment. Overall, "ProFam-Risk" aims to create a best possible counseling and clinical care for men with familial risk to develop PCa. In this pilot study, about 100 men per year will be included for a total period of 3 years. In addition to the registration of clinical, imaging, and genetic information, liquids and tissue (if available) will be sampled for analysis in the above mentioned research questions.

Eligibility Criteria

Inclusion criteria:Healthy men with familial risk ( ≥ 2 first-degree relatives with PCA diagnosed at any age oder ≥ 1 first-degree relative with PCA diagnosed at the age <60)healthy men with genetic risk (BRCA1/2 Germline mutation)Men with PCA and genetic oder familial risk (familial risk = ≥ 2 first-degree relatives with PCA diagnosed at any age oder ≥ 1 first-degree relative with PCA diagnosed at the age <60; genetic risk= BRCA1/2 Germline mutation)Exclusion criteria:<18 yearsno consent

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05681416). StuddyBuddy aggregates publicly available trial information.