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Exploring Men s Prostate Cancer Genetic Risk Perceptions

Exploring Men s Prostate Cancer Genetic Risk Perceptions and Willingness to Give a Biospecimen for Genetic Risk Testing

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06764992
Enrollment
100
Registered
2025-01-09
Start date
2022-08-25
Completion date
2024-06-07
Last updated
2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Genetic Risk Perception and Beliefs, Biospecimen Donation for Genetic Risk Testing

Brief summary

The exploring men's prostate cancer genetic risk perceptions and willingness to give a biospecimen for genetic risk testing study aims to assess prostate cancer genetic risk and susceptibility beliefs among unaffected men of diverse races/ethnicities who are considering undergoing prostate cancer screening and their willingness of men to provide a biospecimen (saliva sample) and test the samples for prostate cancer aggressiveness and determine risk category based on SNP genetic profile.

Interventions

OTHERQuestionnaire

Participants will be asked to complete a questionnaire on demographics, risk beliefs and perception and prostate cancer screening behaviors, intentions and awareness of informed decision making.

OTHERSaliva Sample

Participants will be asked to provide a saliva sample for genetic risk testing to generate a SNP risk profile using a saliva sample collection kit with collection, storage and mailing instructions. We will assess the proportion of consented men who will provide a saliva sample.

Sponsors

H. Lee Moffitt Cancer Center and Research Institute
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Racially/ethnically diverse men with emphasis on Men of African Ancestry. * Age 40 and older . * No personal prostate cancer history/diagnosis. * With or without family history of prostate cancer.

Exclusion criteria

* Previous personal Prostate Cancer history/diagnosis * Under 40 years of age

Design outcomes

Primary

MeasureTime frameDescription
Prostate Cancer Genetic Risk and Susceptibility BeliefsUp to 6 MonthsProstate Cancer Genetic Risk and Susceptibility beliefs will be summarized based on single items on the Prostate Cancer Risk Perception Questionnaire.

Secondary

MeasureTime frameDescription
Polygenic Risk Score (PRS) of Saliva SamplesUp to 6 MonthsPolygenic Risk Score (PRS) of Saliva Samples will be based on genetic profiles from Single Nucleotide Polymorphisms (SNPs). Identified as prostate cancer susceptibility loci, genetic risk of developing prostate cancer will be categorized into 5 groups: Very Low Risk (\< 10%), Low Risk (10-25%) Moderate Risk (25-75%), High Risk (75-90%) or Very High Risk (\>90%).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJong Park, PhD

Moffitt Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026