Prostate Cancer (Diagnosis)NCT07448545
Turkish Version of the UCLA Prostate Cancer Index
An observational study of Prostate Cancer (Diagnosis) and Quality of Life, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial summary
This study will evaluate the cross-cultural adaptation, validity, and reliability of the Turkish version of the UCLA Prostate Cancer Index in men diagnosed with prostate cancer. The original instrument will be translated and culturally adapted following standardized procedures. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer (Diagnosis), Quality of Life, Reliability
- What is being tested?
- Questionnaires
- How many people
- 115 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2022to 28 Jan 2026
- How long will I take part?
- 115 Days
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of men aged 45 years and older who have been diagnosed with prostate cancer and are attending routine follow-up visits at a urology outpatient clinic in Türkiye.
Who may be able to join
- Male patients
- Diagnosis of prostate cancer
Who cannot join
- Severe psychiatric or mental disorders that may impair the ability to complete the questionnaires properly
- Presence of congenital deformities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Lokman Hekim University, Ankara, Ankara
Ankara, 6510
About this study
Official title: Cross-Cultural Adaptation, Reliability and Validity of the UCLA Prostate Cancer Index in Turkish Patients
This study will evaluate the cross-cultural adaptation, validity, and reliability of the Turkish version of the UCLA Prostate Cancer Index in men diagnosed with prostate cancer. The original instrument will be translated and culturally adapted following standardized procedures. The psychometric properties of the Turkish version will be examined in patients attending routine follow-up visits at a urology clinic.
Internal consistency will be assessed using Cronbach's alpha coefficients, and test-retest reliability will be evaluated using intraclass correlation coefficients (ICC) in a subset of participants. Measurement error will be determined by calculating the standard error of measurement (SEM) and the smallest real difference at the 95% confidence level (SRD95). Construct validity will be examined through exploratory factor analysis, and convergent validity will be assessed by testing predefined hypotheses regarding correlations between the UCLA Prostate Cancer Index and established quality-of-life instruments (SF-36 and EORTC QLQ-PR25).
The findings are expected to provide a reliable and valid prostate cancer-specific quality-of-life assessment tool for use in Turkish-speaking populations.
- Conditions
- Prostate Cancer (Diagnosis), Quality of Life, Reliability, Validity, UCLA Prostate Cancer Index
- Being tested
- Questionnaires
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Participants will complete the Turkish version of the UCLA Prostate Cancer Index along with the SF-36 and EORTC QLQ-PR25 questionnaires. No intervention will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer Patients | This cohort will consist of men aged 45 years and older who have been diagnosed with prostate cancer and are attending routine follow-up visits at a urology outpatient clinic Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCLA Prostate Cancer Index
The University of California, Los Angeles (UCLA) Prostate Cancer Index was developed in English in 1998 by Litwin et al. and has been psychometrically validated in prostate cancer populations. It evaluates urinary, sexual, and bowel function and the associated symptom-related bother in men treated for prostate cancer
Measured: 1 hour
EORTC QLQ-PR25
The EORTC QLQ-PR25 is a prostate cancer-specific module consisting of 25 items and comprising six symptom subdomains: urinary symptoms, incontinence aid, bowel symptoms, hormonal treatment-related symptoms, sexual activity, and sexual functioning
Measured: 1 hour
SF-36
It is a widely used 36-item questionnaire that evaluates health-related QoL across eight domains, including physical functioning, role limitations due to physical and emotional problems, mental health, vitality, social functioning, bodily pain, and general health
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start20 Jan 2022
- Primary completion28 Jan 2026
- Study completion28 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Diagnosis)Studies 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
- 115 participants (actual)
- Target duration
- 115 Days
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Demet Öztürk, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448545
- Sponsor's protocol ID
- 2021/14-42
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Cultural Adaptation, Reliability and Validity of the UCLA Prostate Cancer Index in Turkish Patients
- ClinicalTrials.gov ID
- NCT07448545
- Acronym / sponsor ID
- 2021/14-42
- Conditions
- Prostate Cancer (Diagnosis), Quality of Life, Reliability, Validity, UCLA Prostate Cancer Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 4 Mar 2026 (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.
This study will evaluate the cross-cultural adaptation, validity, and reliability of the Turkish version of the UCLA Prostate Cancer Index in men diagnosed with prostate cancer. The original instrument will be translated and culturally adapted following standardized procedures. The psychometric properties of the Turkish version will be examined in patients attending routine follow-up visits at a urology clinic.
Internal consistency will be assessed using Cronbach's alpha coefficients, and test-retest reliability will be evaluated using intraclass correlation coefficients (ICC) in a subset of participants. Measurement error will be determined by calculating the standard error of measurement (SEM) and the smallest real difference at the 95% confidence level (SRD95). Construct validity will be examined through exploratory factor analysis, and convergent validity will be assessed by testing predefined hypotheses regarding correlations between the UCLA Prostate Cancer Index and established quality-of-life instruments (SF-36 and EORTC QLQ-PR25).
The findings are expected to provide a reliable and valid prostate cancer-specific quality-of-life assessment tool for use in Turkish-speaking populations.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 115 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer Patients | – | Other: QuestionnairesThis cohort will consist of men aged 45 years and older who have been diagnosed with prostate cancer and are attending routine follow-up visits at a urology outpatient clinic |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of men aged 45 years and older who have been diagnosed with prostate cancer and are attending routine follow-up visits at a urology outpatient clinic in Türkiye.
Key inclusion criteria (2 listed)
- Male patients
- Diagnosis of prostate cancer
Key exclusion criteria (2 listed)
- Severe psychiatric or mental disorders that may impair the ability to complete the questionnaires properly
- Presence of congenital deformities
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 |
|---|---|---|
| QuestionnairesParticipants will complete the Turkish version of the UCLA Prostate Cancer Index along with the SF-36 and EORTC QLQ-PR25 questionnaires. No intervention will be applied. | Other | Prostate Cancer Patients |
Primary outcome
UCLA Prostate Cancer Index
Time frame: 1 hour
The University of California, Los Angeles (UCLA) Prostate Cancer Index was developed in English in 1998 by Litwin et al. and has been psychometrically validated in prostate cancer populations. It evaluates urinary, sexual, and bowel function and the associated symptom-related bother in men treated for prostate cancer
EORTC QLQ-PR25
Time frame: 1 hour
The EORTC QLQ-PR25 is a prostate cancer-specific module consisting of 25 items and comprising six symptom subdomains: urinary symptoms, incontinence aid, bowel symptoms, hormonal treatment-related symptoms, sexual activity, and sexual functioning
SF-36
Time frame: 1 hour
It is a widely used 36-item questionnaire that evaluates health-related QoL across eight domains, including physical functioning, role limitations due to physical and emotional problems, mental health, vitality, social functioning, bodily pain, and general health
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 5 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (Diagnosis) and Quality of Life, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
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 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 5 Mar 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 Turkey (Türkiye). 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?
UCLA Prostate Cancer Index (time frame: 1 hour). The study lists 3 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 5 Mar 2026.