NCT07197723 Study of How People Make Decisions About Prostate Cancer Risk
| NCT ID | NCT07197723 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | BRCA1/2 |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-09-25 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-09-25 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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)
Contact & Investigator
Jada Hamilton, PhD, MPH
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT07197723 clinical trial?
This trial is open to male participants only, aged 45 Years or older, up to 70 Years, studying BRCA1/2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07197723 currently recruiting?
Yes, NCT07197723 is actively recruiting participants. Contact the research team at hamiltoj@mskcc.org for enrollment information.
Where is the NCT07197723 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07197723 clinical trial?
NCT07197723 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Jada Hamilton, PhD, MPH at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 150 participants.