NCT07416812

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

February 6, 2026

Last Update Submit

February 13, 2026

Conditions

Prostate CancerHereditary Prostate Cancer

Keywords

targeted screeninggenetic predisposition

Outcome Measures

Primary Outcomes (1)

  • 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.

    Once during follow-up (up to 12 months)

Study Arms (2)

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.

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.

Other: Telephone Follow-Up Interview

Interventions

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).

BRCA1/BRCA2 Mutation Carriers
Telephone Follow-Up InterviewOTHER

Telephone interview to assess whether participants developed prostate cancer in 2025 and to collect updated personal and family medical history.

Control Group (Non-Carriers)

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Prostatic NeoplasmsProstate cancer, familialGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
2
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 18, 2026

Study Start

March 29, 2021

Primary Completion

November 30, 2021

Study Completion

December 31, 2025

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)