NCT07416812

Targeted Prostate Cancer Screening in Men With BRCA1/2 Mutations

The Identification of Men With a Genteic Predisposition to Prostate Cancer: Targeted Screening in Men at Higer Genetic Risk and Controls Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Institute of Oncology Ljubljana · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prostate Cancer
• Hereditary Prostate Cancer

Interventions

Type	Name	Description
OTHER	Targeted 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).
OTHER	Telephone Follow-Up Interview	Telephone interview to assess whether participants developed prostate cancer in 2025 and to collect updated personal and family medical history.

Timeline

• Start date: 2021-03-29
• Primary completion: 2021-11-30
• Completion: 2025-12-31
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: Slovenia