Targeted Prostate Cancer Screening in Men With BRCA1/2 Mutations

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.

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Key information

Conditions

Prostate Cancer Disease Attributes Disease Susceptibility Genetic Predisposition to Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hereditary Prostate Cancer Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate cancer, familial Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Targeted Prostate Cancer Screening

Other

Participants undergo targeted prostate cancer screening according to the IMPACT study protocol (e.g., PSA testing and further diagnostic assessment if indicated).

Telephone Follow-Up Interview

Other

Telephone interview to assess whether participants developed prostate cancer in 2025 and to collect updated personal and family medical history.

Primary outcomes

Prostate Cancer Diagnosis (Telephone Follow-up Interview)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Official study title

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

Acronym: IMPACT

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2025
First posted: Feb 18, 2026
Registry last updated: Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed