Prostate CancerIMPACTNCT07416812
Targeted Prostate Cancer Screening in Men With BRCA1/2 Mutations
A study testing Targeted Prostate Cancer Screening and Telephone Follow-Up Interview in people with Prostate Cancer and Hereditary Prostate Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Hereditary Prostate Cancer
- What is being tested?
- Targeted Prostate Cancer Screening and Telephone Follow-Up Interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSlovenia
- Study dates
- 29 Mar 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer, Hereditary Prostate Cancer
- Being tested
- Targeted Prostate Cancer Screening, Telephone Follow-Up Interview
- Keywords
- targeted screening, genetic predisposition
- Medical subject headings
- Prostatic Neoplasms, Prostate cancer, familial, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Prostate Cancer ScreeningOther
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 InterviewOther
Telephone interview to assess whether participants developed prostate cancer in 2025 and to collect updated personal and family medical history.
| Study group | Role | What they receive |
|---|---|---|
| BRCA1/BRCA2 Mutation Carriers | Experimental | 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. Receives: Other: Targeted Prostate Cancer Screening |
| Control Group (Non-Carriers) | Active comparator | 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. Receives: Other: Telephone Follow-Up Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate Cancer Diagnosis (Telephone Follow-up Interview)
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.
Measured: Once during follow-up (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start29 Mar 2021
- Primary completion30 Nov 2021
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416812
- Sponsor's protocol ID
- 132/02/08
- Other IDs
- 0120-202/2021/4
- Acronym
- IMPACT
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Identification of Men With a Genteic Predisposition to Prostate Cancer: Targeted Screening in Men at Higer Genetic Risk and Controls Study
- ClinicalTrials.gov ID
- NCT07416812
- Acronym / sponsor ID
- IMPACT / 132/02/08
- Conditions
- Prostate Cancer, Hereditary Prostate Cancer
- Keywords
- targeted screening, genetic predisposition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRCA1/BRCA2 Mutation Carriers | Experimental | Other: Targeted Prostate Cancer ScreeningMen 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 InterviewMen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted Prostate Cancer ScreeningParticipants undergo targeted prostate cancer screening according to the IMPACT study protocol (e.g., PSA testing and further diagnostic assessment if indicated). | Other | BRCA1/BRCA2 Mutation Carriers |
| Telephone Follow-Up InterviewTelephone interview to assess whether participants developed prostate cancer in 2025 and to collect updated personal and family medical history. | Other | Control Group (Non-Carriers) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Prostate Cancer Screening and Telephone Follow-Up Interview in people with Prostate Cancer and Hereditary Prostate Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate Cancer Diagnosis (Telephone Follow-up Interview) (time frame: Once during follow-up (up to 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.