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OpenTrials
Completed

NCT Number: NCT06764992

Exploring Men s Prostate Cancer Genetic Risk Perceptions

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

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.

Saliva Sample

Other

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.

Primary outcomes

  1. Prostate Cancer Genetic Risk and Susceptibility Beliefs

    Time frame: 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 outcomes

  1. Polygenic Risk Score (PRS) of Saliva Samples

    Time frame: 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%).

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2025
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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