Hereditary Prostate Cancer, Prostate Cancer
Conditions
Keywords
targeted screening, genetic predisposition
Brief summary
This interventional study is a follow-up component of the IMPACT project, which aims to identify men at increased hereditary risk of prostate cancer. The study focuses on men carrying BRCA1 and BRCA2 germline mutations and a control group of non-carriers. Participants are contacted by telephone to determine whether they developed prostate cancer during 2025 and to collect updated personal and family medical history information. The goal of the study is to support targeted prostate cancer screening programs in men at higher genetic risk.
Detailed description
Prostate cancer is one of the most common malignancies in men. Individuals carrying germline mutations in BRCA1 and BRCA2 genes are at increased risk of developing prostate cancer and may benefit from targeted screening strategies. The IMPACT study was designed to evaluate early detection approaches in men with hereditary predisposition to prostate cancer. This study represents a follow-up assessment within the IMPACT framework. Men with BRCA1 or BRCA2 mutations and a control group of non-carriers are contacted by telephone to collect updated information on prostate cancer diagnosis and other relevant changes in personal and family medical history during the year 2025. The collected information will contribute to evaluation of prostate cancer incidence in genetically predisposed individuals and may support the development and optimization of targeted prostate cancer screening programs for high-risk populations.
Interventions
OTHERTargeted Prostate Cancer Screening
Participants undergo targeted prostate cancer screening according to the IMPACT study protocol (e.g., PSA testing and further diagnostic assessment if indicated).
OTHERTelephone Follow-Up Interview
Telephone interview to assess whether participants developed prostate cancer in 2025 and to collect updated personal and family medical history.
Sponsors
Institute of Oncology Ljubljana
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Masking description
2
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male participants aged 18 years or older * BRCA1 or BRCA2 mutation carriers or non-carrier controls enrolled in the IMPACT study * Eligible for targeted prostate cancer screening and follow-up * Ability to participate in telephone follow-up interview * Written informed consent provided
Exclusion criteria
* History of prostate cancer prior to enrollment * Inability to provide informed consent or complete follow-up procedures * Any condition that, in the investigator's opinion, would interfere with study participation or data quality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prostate Cancer Diagnosis (Telephone Follow-up Interview) | Once during follow-up (up to 12 months) | Prostate cancer diagnosis will be assessed by telephone follow-up interview and review of available medical history. Participants will be asked whether they have been diagnosed with prostate cancer since the last study contact. Updated personal and family medical history will also be collected. |
Countries
Slovenia
Outcome results
None listed