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

Institute of Oncology Ljubljana

Status: Completed

Conditions: Hereditary Prostate Cancer; Prostate Cancer

Treatments: Other: Telephone Follow-Up Interview; Other: Targeted Prostate Cancer Screening

Study type: Interventional

Funder types: Other

Identifiers

NCT07416812

0120-202/2021/4 (Other Identifier)

132/02/08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: Male

Ages: 18+ years old

Volunteers: 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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 2 patient groups

BRCA1/BRCA2 Mutation Carriers

Experimental group

Description:

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.

Treatment:

Other: Targeted Prostate Cancer Screening

Control Group (Non-Carriers)

Active Comparator group

Description:

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.

Treatment:

Other: Telephone Follow-Up Interview