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.
52 trials monitored
See 2 trials at risk
2,471 trials monitored
See 156 trials at risk
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.
| 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 |