Prostate CarcinomaNCT06900348
Prostate Specific Antigen Levels of Individuals Living in Rural Areas
An observational study of Prostate Carcinoma, run by Suleyman Demirel University.
Trial summary
It was planned in cross-sectional design in order to determine the specific prostate antigen level and some characteristics and the relationship evaluations and prostate specific antigen formation in individuals living in rural areas. Read more about this study
- Who is it for?
- Ages 55 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- PSA-Activated PSA-PAH1
- Type of treatment
- Injection or infusion
- How many people
- 308 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2025to 30 Aug 2025
- Phase
- Observational
- 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 55 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male 55 years or older
Who may be able to join
- Male
- 55 years or older
Who cannot join
- -Prostate treatment
About this study
Official title: Prostate Specific Antigen Levels and Its Relationship With Some Characteristics in Individuals Living in Rural Areas: A Cross-Sectional Study
It was planned in cross-sectional design in order to determine the specific prostate antigen level and some characteristics and the relationship evaluations and prostate specific antigen formation in individuals living in rural areas. It was planned to perform socio-demographic information formula, form including social information of health, prostate specific antigen test in the project data recording.
Read the detailed description
It was planned in a cross-sectional design to evaluate the prostate specific antigen level and its relationship with some characteristics in elderly individuals living in rural areas and to determine the prostate specific antigen level. The research area of the project consists of 8 villages. In the collection of project data, it was planned to conduct a socio-demographic feature information form, a form including social determinants of health, and a prostate specific antigen test. This planned project is the first research to be conducted in our country in terms of determining risky groups, ensuring randomness in participants, and sampling method for universe representation. In addition, screening the rural area, which is disadvantaged in terms of socio-economic and demographic aspects, and preferring elderly individuals constitute the steps taken to ensure health equality of the disadvantaged group in terms of health service transportation opportunities.
- Conditions
- Prostate Carcinoma
- Being tested
- PSA-Activated PSA-PAH1
- Keywords
- Prostate Carcinoma, Screening
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSA-Activated PSA-PAH1Diagnostic test
Intravenous blood sample
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA levels
For ages 60-69: 0 - 4.5 ng/ml, For ages 70 and above: 0 - 6.5 ng/ml
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start25 Mar 2025 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies 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
- Cross-sectional
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feyza Bardak, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900348
- Sponsor's protocol ID
- TSTK-2024-9546
- Other IDs
- Suleyman Demirel Universty
- Status last verified
- Mar 2025
- First submitted
- 22 Mar 2025
- Last updated
- 30 Mar 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Specific Antigen Levels and Its Relationship With Some Characteristics in Individuals Living in Rural Areas: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06900348
- Acronym / sponsor ID
- TSTK-2024-9546
- Conditions
- Prostate Carcinoma
- Keywords
- Prostate Carcinoma, Screening
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 25 Mar 2025 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 28 Mar 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.
It was planned in cross-sectional design in order to determine the specific prostate antigen level and some characteristics and the relationship evaluations and prostate specific antigen formation in individuals living in rural areas. It was planned to perform socio-demographic information formula, form including social information of health, prostate specific antigen test in the project data recording.
Detailed description
It was planned in a cross-sectional design to evaluate the prostate specific antigen level and its relationship with some characteristics in elderly individuals living in rural areas and to determine the prostate specific antigen level. The research area of the project consists of 8 villages. In the collection of project data, it was planned to conduct a socio-demographic feature information form, a form including social determinants of health, and a prostate specific antigen test. This planned project is the first research to be conducted in our country in terms of determining risky groups, ensuring randomness in participants, and sampling method for universe representation. In addition, screening the rural area, which is disadvantaged in terms of socio-economic and demographic aspects, and preferring elderly individuals constitute the steps taken to ensure health equality of the disadvantaged group in terms of health service transportation opportunities.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 55 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male 55 years or older
Key inclusion criteria (2 listed)
- Male
- 55 years or older
Key exclusion criteria (1 listed)
- -Prostate treatment
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 |
|---|---|---|
| PSA-Activated PSA-PAH1Intravenous blood sample | Diagnostic test | – |
Primary outcome
PSA levels
Time frame: 6 months
For ages 60-69: 0 - 4.5 ng/ml, For ages 70 and above: 0 - 6.5 ng/ml
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 30 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Carcinoma, run by Suleyman Demirel University.
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 2 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: opening soon, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
PSA levels (time frame: 6 months). 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 30 Mar 2025.