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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Racially and ethnically diverse Adult Men with no personal Prostate Cancer history/diagnosis.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prostate Cancer Risk Group
Participants will be asked to provide saliva samples and complete a questionnaire about their Prostate Cancer Genetic Risk beliefs.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%).

Up to 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jong Park, PhD, Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2022

Primary Completion (Actual)

April 20, 2024

Study Completion (Actual)

June 7, 2024

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

January 9, 2025

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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