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

Study acronym: ProFam-Risk
StatusNot Yet Recruiting
PhaseNot applicable
Started2023-02-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 12, 2023 (before its estimated February 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT05681416
Lead Sponsor Heinrich-Heine University, Duesseldorf
Collaborators: German Cancer Aid
Conditions Prostate Cancer, Familial Prostate Cancer
Enrollment 300 participants
Start Date 2023-02-01
Primary Completion 2026-02-01 (estimated)
Study Completion 2027-02-01 (estimated)
Updated on ClinicalTrials.gov 2023-01-12