Exploring Men s Prostate Cancer Genetic Risk Perceptions

NCT06764992 | Completed

• 1 other identifier: MCC-21876
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Prostate Cancer Genetic Risk and Susceptibility Beliefs

  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 Outcomes (1)

• Polygenic Risk Score (PRS) of Saliva Samples

  Up to 6 Months

Study Arms (1)

Prostate Cancer Risk Group

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

Other: Questionnaire; Other: Saliva Sample

Interventions

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.

Prostate Cancer Risk Group

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.

Prostate Cancer Risk Group

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: This Study is evaluating Prostate Cancer risk
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials Website

Biospecimen

Retention: SAMPLES WITH DNA

Participants will be asked to provide a saliva sample. Each enrolled participant will be provided the Oragene saliva collection kit (opt in) with collection, storage and mailing instructions per established protocols DNA extraction and genotyping assay will be done in Dr. Park's (PI) laboratory and Moffitt Cancer Center's Molecular Genomic Core facility, respectively

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jong Park, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 9, 2025
• Study Start: August 25, 2022
• Primary Completion: April 20, 2024
• Study Completion: June 7, 2024
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (1)