Targeted Prostate Cancer Screening in Men With BRCA1/2 Mutations

NCT07416812 — Not applicable, Completed, 25 participants, Institute of Oncology Ljubljana

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

Registry	NCT07416812, acronym IMPACT
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, single group, masking: none, screening
Enrollment	25 (Actual)
Sponsor	Institute of Oncology Ljubljana (Other)
Conditions	Prostate Cancer, Hereditary Prostate Cancer
Interventions	Targeted Prostate Cancer Screening, Telephone Follow-Up Interview (Other)
Dates	start 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 in Slovenia

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
BRCA1/BRCA2 Mutation Carriers	Experimental	Other: Targeted Prostate Cancer Screening	Men carrying a BRCA1 or BRCA2 germline mutation enrolled in the IMPACT targeted prostate cancer screening study and followed up with telephone interview for updated medical and family history, including prostate cancer diagnosis.
Control Group (Non-Carriers)	Active comparator	Other: Telephone Follow-Up Interview	Men without BRCA1/BRCA2 mutations enrolled as controls in the IMPACT targeted prostate cancer screening study and followed up with telephone interview for updated medical and family history, including prostate cancer diagnosis.

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.

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: Male, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Institute of Oncology Ljubljana	Ljubljana	Slovenia