Prostate CancerNCT04550845
Understanding of Genetics by Men at Risk for Prostate Cancer
A study testing Focus group analyses in people with Prostate Cancer, run by Mayo Clinic at 3 sites in United States.
Trial summary
With this greater certainty regarding prognosis, men with localized prostate cancer are now equipped with make better treatment planning decisions. This study is designed to investigate the understanding of prognostic genetic technology in African American and rural White men at risk for localized prostate cancer. Read more about this study
- Who is it for?
- Ages 40 to 95 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Focus group analyses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2023to 27 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 95 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African-American or White men
- Living in a rural or urban areas
- Age 40 to 95 years old
- Able and willing to provide informed consent
- English-speaking
- Willing to participate in the study.
- This study will use the United States Department of Agriculture Office of Rural Development's definition of rural, which is as a city or town that has a population less than 50,000 inhabitants to define rural.
- This study will use the United States Census Bureau's definition of urban, which is a city or town that has a population greater than 50,000 inhabitants to define urban.
Who cannot join
- Women will be excluded from participating in this study. However, women will be recruited to serve on an advisory panel to review the video-based educational tool for the comprehension of genomic terminology for prognostic genetic testing in patients with localized prostate cancer.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Folakemi Odedina, PhD
- Recruiting
Mayo Clinic
Phoenix, Arizona, 85054
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Ewan K. Cobran, PhD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Christi A. Patten, PhD
About this study
With this greater certainty regarding prognosis, men with localized prostate cancer are now equipped with make better treatment planning decisions. This study is designed to investigate the understanding of prognostic genetic technology in African American and rural White men at risk for localized prostate cancer.
Read the detailed description
Novel genomic technology, such as microarray analyses and next-generation sequencing, have improved the understanding of prostate cancer biology and prognosis. The National Comprehensive Cancer Network (NCCN), in 2016, recommended that patients and clinicians consider tissue-based genetic tests for localized prostate cancer. However, while much enthusiasm currently exits for the rapidly increasing field of genomic medicine, the use of multi-gene mRNA expression panels raises the potential for further divergence in prostate cancer treatment outcomes by race and low socioeconomic status. We know that health disparities persist in low income groups despite the existence of evidence-based guidelines and that adoption of state-of-the-art methods often lag behind in these groups.
The goals of this study are to explore how men at risk for localized prostate cancer comprehend prognostic genetic technology, and examine how an educational video about genetics impacts patient-caregiver communication of prognostic genetic technology. The study rationale is that without direct attention to genomic comprehension, the enthusiasm that exists in the rapidly increasing field of prostate cancer genomic medicine may not translate into health benefits for men with localized prostate cancer. The central hypotheses are men with lower levels of education will demonstrate a severe lack of genomic comprehension of tissue-based genetic tests for localized prostate cancer; and tailored prostate cancer education will significantly improve communication in a low literacy population.
The study approach is innovative because it applies a mixed-methods community-engagement research framework to explore how African American and rural White men at risk for localized prostate cancer, comprehend and interpret data generated from genetic technology. The proposed research is significant because of its potential to improve public health by improving the understanding of prognostic genetics in minority, low income, and rural populations, and engage and educate these diverse communities about genomics.
- Conditions
- Prostate Cancer
- Being tested
- Focus group analyses
- Keywords
- Prostate Cancer, Genetic Literacy, Heath Communication, Focus Group Discussions, Prognostic Genomics Technology
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus group analysesBehavioural
Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14 for analysis.
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video. | Experimental | Focus group discussions about the PCGLA educational video post-study. Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14. A data dictionary will be created for each technical term to establish acceptable and unacceptable responses. Trained coders will evaluate comprehension of the technical terms independently and then resolve disagreement by consensus. Receives: Behavioral: Focus group analyses |
| Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video plus Communication Coaching. | Experimental | Focus group discussions about the PCGLA educational plus nurse-navigated, tailored, prostate cancer education and communication coaching post-study.
Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14. A data dictionary will be created for each technical term to establish acceptable and unacceptable responses. Trained coders will evaluate comprehension of the technical terms independently and then resolve disagreement by consensus. post-study. Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14. A data dictionary will be created for each technical term to establish acceptable and unacceptable responses. Trained coders will evaluate comprehension of the technical terms independently and then resolve disagreement by consensus. Receives: Behavioral: Focus group analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate Genetic Literacy
The Rapid Estimate of Adult Literacy in Genetic - Short Form: An 8-item measure to asses adult literacy in genetics will be used.
Measured: Baseline
Estimate Genetic Literacy
The Rapid Estimate of Adult Literacy in Genetic - Short Form: An 8-item measure to asses adult literacy in genetics will be used.
Measured: Pre-intervention
Estimate Genetic Literacy
The Rapid Estimate of Adult Literacy in Genetic - Short Form: An 8-item measure to asses adult literacy in genetics will be used.
Measured: Immediately after the intervention
Prostate Cancer Genetic Understanding
The Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video, which was developed for this research, will be used as the study educational intervention. Prostate Cancer Genetic understanding will be assess with an 18-item knowledge prostate cancer genetic survey. The items are True or False.
Measured: Baseline
Focus Group Discussion
A semi-structured focus group discussion about the Prostate Cancer Genetic Literacy Application (PCGLA) educational video.
Measured: Baseline
Focus Group Discussion
A semi-structured focus group discussion about the Prostate Cancer Genetic Literacy Application (PCGLA) educational video.
Measured: Immediately after the intervention
Secondary outcomes (4)
Prostate Cancer Knowledge Scale
The Prostate Cancer Knowledge Scales a 12-item self-report measure developed to assess men's knowledge of prostate cancer risk factors, symptoms, prevention, screening, and treatment. Response options were multiple choice or true/false with each question also including an I don't know response option. Scoring was based on the percentage of questions answered correctly and ranged from 0 to 100.
Measured: Baseline
Prostate Cancer Knowledge Scale
The Prostate Cancer Knowledge Scales a 12-item self-report measure developed to assess men's knowledge of prostate cancer risk factors, symptoms, prevention, screening, and treatment. Response options were multiple choice or true/false with each question also including an I don't know response option. Scoring was based on the percentage of questions answered correctly and ranged from 0 to 100.
Measured: Pre-intervention
Prostate Cancer Knowledge Scale
The Prostate Cancer Knowledge Scales a 12-item self-report measure developed to assess men's knowledge of prostate cancer risk factors, symptoms, prevention, screening, and treatment. Response options were multiple choice or true/false with each question also including an I don't know response option. Scoring was based on the percentage of questions answered correctly and ranged from 0 to 100.
Measured: Immediately after the intervention
Demographic Characteristics
Patients will be asked ended-questions to assess (1) race, (2) age, (3) marital status, (4) employment status, (5) current and/or past prostate cancer diagnoses, (6) occupation, (7) level of education, and 8) income.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 May 2023
- Primary completion27 Sep 2027 (estimated)
- Study completion27 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ewan Cobran, Ph.D., Mayo Clinic
- Investigators
- Ewan K Cobran, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550845
- Sponsor's protocol ID
- 22-011303
- Other IDs
- K01CA230193, NCI-2023-05978
- Status last verified
- Oct 2025
- First submitted
- 9 Sep 2020
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding of Genetics by Men at Risk for Prostate Cancer
- ClinicalTrials.gov ID
- NCT04550845
- Acronym / sponsor ID
- 22-011303
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Genetic Literacy, Heath Communication, Focus Group Discussions, Prognostic Genomics Technology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 27 Sep 2027 (estimated)
- Study completion
- 27 Sep 2027 (estimated)
- First posted
- 16 Sep 2020 (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.
With this greater certainty regarding prognosis, men with localized prostate cancer are now equipped with make better treatment planning decisions. This study is designed to investigate the understanding of prognostic genetic technology in African American and rural White men at risk for localized prostate cancer.
Detailed description
Novel genomic technology, such as microarray analyses and next-generation sequencing, have improved the understanding of prostate cancer biology and prognosis. The National Comprehensive Cancer Network (NCCN), in 2016, recommended that patients and clinicians consider tissue-based genetic tests for localized prostate cancer. However, while much enthusiasm currently exits for the rapidly increasing field of genomic medicine, the use of multi-gene mRNA expression panels raises the potential for further divergence in prostate cancer treatment outcomes by race and low socioeconomic status. We know that health disparities persist in low income groups despite the existence of evidence-based guidelines and that adoption of state-of-the-art methods often lag behind in these groups.
The goals of this study are to explore how men at risk for localized prostate cancer comprehend prognostic genetic technology, and examine how an educational video about genetics impacts patient-caregiver communication of prognostic genetic technology. The study rationale is that without direct attention to genomic comprehension, the enthusiasm that exists in the rapidly increasing field of prostate cancer genomic medicine may not translate into health benefits for men with localized prostate cancer. The central hypotheses are men with lower levels of education will demonstrate a severe lack of genomic comprehension of tissue-based genetic tests for localized prostate cancer; and tailored prostate cancer education will significantly improve communication in a low literacy population.
The study approach is innovative because it applies a mixed-methods community-engagement research framework to explore how African American and rural White men at risk for localized prostate cancer, comprehend and interpret data generated from genetic technology. The proposed research is significant because of its potential to improve public health by improving the understanding of prognostic genetics in minority, low income, and rural populations, and engage and educate these diverse communities about genomics.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video. | Experimental | Behavioral: Focus group analysesFocus group discussions about the PCGLA educational video post-study. Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14. A data dictionary will be created for each technical term to establish acceptable and unacceptable responses. Trained coders will evaluate comprehension of the technical terms independently and then resolve disagreement by consensus. |
| Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video plus Communication Coaching. | Experimental | Behavioral: Focus group analysesFocus group discussions about the PCGLA educational plus nurse-navigated, tailored, prostate cancer education and communication coaching post-study. Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14. A data dictionary will be created for each technical term to establish acceptable and unacceptable responses. Trained coders will evaluate comprehension of the technical terms independently and then resolve disagreement by consensus. post-study. Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14. A data dictionary will be created for each technical term to establish acceptable and unacceptable responses. Trained coders will evaluate comprehension of the technical terms independently and then resolve disagreement by consensus. |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- African-American or White men
- Living in a rural or urban areas
- Age 40 to 95 years old
- Able and willing to provide informed consent
- English-speaking
Key exclusion criteria (1 listed)
- Women will be excluded from participating in this study. However, women will be recruited to serve on an advisory panel to review the video-based educational tool for the comprehension of genomic terminology for prognostic genetic testing in patients with localized prostate cancer.
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 |
|---|---|---|
| Focus group analysesFocus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14 for analysis. | Behavioural | Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video plus Communication Coaching., Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video. |
Primary outcome
Estimate Genetic Literacy
Time frame: Baseline
The Rapid Estimate of Adult Literacy in Genetic - Short Form: An 8-item measure to asses adult literacy in genetics will be used.
Estimate Genetic Literacy
Time frame: Pre-intervention
The Rapid Estimate of Adult Literacy in Genetic - Short Form: An 8-item measure to asses adult literacy in genetics will be used.
Estimate Genetic Literacy
Time frame: Immediately after the intervention
The Rapid Estimate of Adult Literacy in Genetic - Short Form: An 8-item measure to asses adult literacy in genetics will be used.
Prostate Cancer Genetic Understanding
Time frame: Baseline
The Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video, which was developed for this research, will be used as the study educational intervention. Prostate Cancer Genetic understanding will be assess with an 18-item knowledge prostate cancer genetic survey. The items are True or False.
Focus Group Discussion
Time frame: Baseline
A semi-structured focus group discussion about the Prostate Cancer Genetic Literacy Application (PCGLA) educational video.
Focus Group Discussion
Time frame: Immediately after the intervention
A semi-structured focus group discussion about the Prostate Cancer Genetic Literacy Application (PCGLA) educational video.
4 secondary outcomes
Prostate Cancer Knowledge Scale
Time frame: Baseline
Prostate Cancer Knowledge Scale
Time frame: Pre-intervention
Prostate Cancer Knowledge Scale
Time frame: Immediately after the intervention
Demographic Characteristics
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ewan K Cobran, PhD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focus group analyses in people with Prostate Cancer, run by Mayo Clinic at 3 sites 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 8 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ewan K Cobran, PhD (480-301-6392, cobran.ewan@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate Genetic Literacy (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2025.