Exploring Men s Prostate Cancer Genetic Risk Perceptions

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT06764992
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-25
• Primary Completion: 2024-04-20
• Study Completion: 2024-06-07
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-08
• Study First Posted: 2025-01-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prostate Cancer Genetic Risk and Susceptibility Beliefs	Up to 6 Months	Prostate Cancer Genetic Risk and Susceptibility beliefs will be summarized based on single items on the Prostate Cancer Risk Perception Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Polygenic Risk Score (PRS) of Saliva Samples	Up to 6 Months	Polygenic 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%).

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States