Prostate CancerNCT06764992
Exploring Men s Prostate Cancer Genetic Risk Perceptions
An observational study of Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Questionnaire and Saliva Sample
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2022to 7 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Racially and ethnically diverse Adult Men with no personal Prostate Cancer history/diagnosis.
Who may be able to join
- 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.
Who cannot join
- Previous personal Prostate Cancer history/diagnosis
- Under 40 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Prostate Cancer
- Being tested
- Questionnaire, Saliva Sample
- Keywords
- Genetic Risk Perception and Beliefs, Biospecimen Donation for Genetic Risk Testing
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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 SampleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer Risk Group | Participants will be asked to provide saliva samples and complete a questionnaire about their Prostate Cancer Genetic Risk beliefs. Receives: Other: Questionnaire; Other: Saliva Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 Months
Secondary outcomes (1)
Polygenic Risk Score (PRS) of Saliva Samples
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%).
Measured: Up to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start25 Aug 2022
- Primary completion20 Apr 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong Park, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764992
- Sponsor's protocol ID
- MCC-21876
- Status last verified
- Feb 2026
- First submitted
- 7 Jan 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boxtha C, El-Kolalli S, Denis J, O'Neil A, Vadaparampil ST, Abdulla R, Park H, Park JY, Gwede CK. Feasibility of Recruitment, Perceived Genetic Risk and Susceptibility Beliefs, and Saliva Sample Collection in a Community-Based Prostate Cancer Genetic Risk Pilot Study. Am J Mens Health. 2026 Jan-Feb;20(1):15579883251410526. doi: 10.1177/15579883251410526. Epub 2026 Jan 8.
PubMed 41506624
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Men s Prostate Cancer Genetic Risk Perceptions and Willingness to Give a Biospecimen for Genetic Risk Testing
- ClinicalTrials.gov ID
- NCT06764992
- Acronym / sponsor ID
- MCC-21876
- Conditions
- Prostate Cancer
- Keywords
- Genetic Risk Perception and Beliefs, Biospecimen Donation for Genetic Risk Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer Risk Group | – | Other: Questionnaire, Other: Saliva SampleParticipants will be asked to provide saliva samples and complete a questionnaire about their Prostate Cancer Genetic Risk beliefs. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Racially and ethnically diverse Adult Men with no personal Prostate Cancer history/diagnosis.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Previous personal Prostate Cancer history/diagnosis
- Under 40 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireParticipants 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. | Other | Prostate Cancer Risk Group |
| Saliva SampleParticipants 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. | Other | Prostate Cancer Risk Group |
Primary outcome
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.
1 secondary outcome
Polygenic Risk Score (PRS) of Saliva Samples
Time frame: Up to 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Derived from this study: PubMed 41506624Boxtha C, El-Kolalli S, Denis J, O'Neil A, Vadaparampil ST, Abdulla R, Park H, Park JY, Gwede CK. Feasibility of Recruitment, Perceived Genetic Risk and Susceptibility Beliefs, and Saliva Sample Collection in a Community-Based Prostate Cancer Genetic Risk Pilot Study. Am J Mens Health. 2026 Jan-Feb;20(1):15579883251410526. doi: 10.1177/15579883251410526. Epub 2026 Jan 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Park, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate Cancer Genetic Risk and Susceptibility Beliefs (time frame: Up to 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06764992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.