CompletedNot Applicable

Targeted Prostate Cancer Screening in Men With BRCA1/2 Mutations

Slovenia25 participantsStarted 2021-03-29

Plain-language 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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prostate Cancer Diagnosis (Telephone Follow-up Interview)

Timeframe: Once during follow-up (up to 12 months)

Trial details

NCT IDNCT07416812

SponsorInstitute of Oncology Ljubljana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-30

View on ClinicalTrials.gov More Prostate Cancer trials