Targeted Prostate Cancer Screening in Men With BRCA1/2 Mutations (IMPACT)

February 13, 2026 updated by: Institute of Oncology Ljubljana

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Institute of Oncology Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BRCA1/BRCA2 Mutation Carriers
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.
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).
Active Comparator: Control Group (Non-Carriers)
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Once during follow-up (up to 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Oncology Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2021

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 132/02/08
  • 0120-202/2021/4 (Other Identifier: Ministry of Health of the Republic of Slovenia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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