Clinical trial · Observational
Study of How People Make Decisions About Prostate Cancer Risk
Effect of Polygenic Risk Modifiers on Decisions of BRCA1/2 Mutation Carriers at Risk for Prostate Cancer
NCT07197723CI-TRIAL-00117485recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to learn how people with BRCA1/2 mutations respond to genetic risk modifier testing. The researchers will learn more about how people make choices about their health care, including about methods to screen for prostate cancer. Researchers are also doing this study to learn about how the genetic risk modifier test affects people's thoughts and feelings.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA1/2 | — | UNRESOLVED | — |
| Geneitic Testing | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessments | Other | — | UNRESOLVED |
| cheek (buccal) swab | Genetic | — | UNRESOLVED |
| optional collection of blood | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Men with BRCA1/2 mutations who are at risk for prostate cancer
- description
- Will be offered genetic risk modifier testing (note that this testing is of clinical grade but is not yet standard of care and is therefore only available through the context of this research study), and will complete baseline and then 1-week, 6-month, and 12-month post-receipt of modifier results follow-up quantitative assessments of their psychological and behavioral outcomes. Participants will also be asked to complete the standard CGS Family History Questionnaire, once their baseline assessment is completed. This information will be used to inform genetic counsellors/study doctors during the patients' genetic risk modifier testing results disclosure appointment.
- interventionNames
- Genetic: cheek (buccal) swab
- Other: Assessments
- Other: optional collection of blood
Primary outcomes (1)
- measure
- Intention to undergo prostate cancer screening options
- timeFrame
- 6 months
- description
- Change in intention for each screening option measured with the Choice predisposition scale. Choice Predisposition scale ranges from 1 (leaning towards yes) to 15 (leaning towards no) regarding a specific option.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Documentation of Disease o Patients must not have prostate cancer (for individuals not presently receiving care at the study site, this information will be based on self-report.) * Age between 45 - 70; * Assigned male sex at birth for individuals not presently receiving care at the study site, this information will be based on self-report.) * Completed full sequence or targeted genetic testing with a result confirmed in a clinically approved laboratory showing a BRCA1/2 likely pathogenic or pathogenic variant identified, or clinician note documents a BRCA1/2 likely pathogenic or pathogenic variant * English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.(for individuals not presently receiving care at the study site, this information will be based on self-report.) Exclusion Criteria: * Major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation. * Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff. * Under active treatment for a malignancy. (Patients are eligible if they have a prior history of malignancy other than prostate cancer, as long as they are not currently undergoing active treatment for the malignancy) (for individuals not presently receiving care at the study site, this information will be based on self-report.) * Enrolled in NCI study 19-C-0040 (Natural History of Men at High-Risk for Prostate Cancer) based on self-report * Patients with a known pathogenic and/or likely pathogenic germline variant in any hereditary prostate cancer risk gene, excluding BRCA1 and/or BRCA2, including but not limited to: HOXB13, ATM, CHEK2, NBN, PALB2, MLH1, MSH2, MSH6, PMS2,RAD51C, RAD51D and TP53. * Any patient who has had a prostate biopsy within 36 months, according to clinician note (for individuals not presently receiving care at the study site, this information will be based on self-report)
References
Publications (0)
Data not yet available
No reference posted for this study.