Study of How People Make Decisions About Prostate Cancer Risk

ConditionsBRCA1/2 Geneitic Testing

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexMale

Age45-70

SponsorMemorial Sloan Kettering Cancer Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Documentation of Disease

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

Disqualifiers

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

Trial population

Potential participants (i.e., male MSK patients with a documented BRCA1/2 PV) will be identified by study staff who will screen relevant clinic schedules (e.g., for the MSK CATCH high-risk screening clinic, for post-test visits in the MSK CGS) and approached by their clinician (primary genetic counselor, and/or clinician in the high-risk screening clinic or other MSK clinician) with support from study staff. Or non-MSK patients (e.g., community members) who are referred to the study by study clinicians.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

cheek (buccal) swab
Genetic
swab sample in person or at home with a mailed test kit and will fill out a survey
Assessments
Other intervention
about 1 week, 6 months, and 12 months after getting the updated cancer risk assessment to complete additional surveys.
optional collection of blood
Other intervention
for research testing

Treatment groups

150 Participants

are divided into 1 treatment group

Group A: Men with BRCA1/2 mutations who are at risk for prostate cancer3 interventions

Trial outcomes

Primary outcomes

Intention to undergo prostate cancer screening options

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.

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

CureBRCA Foundation

Collaborator

Source ClinicalTrials.gov

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