Prostate CancerNCT07048613
Comparative Study of MRI and TU in Identifying Clinically Significant Prostate Cancer Among Ethnic Groups
An observational study of Prostate Cancer, run by Superior University at 1 site in Pakistan.
Trial summary
This study is designed to compare the diagnostic accuracy of Magnetic Resonance Imaging (MRI) and Transrectal Ultrasound (TRUS) in detecting clinically significant prostate cancer, using histopathology (biopsy results) as the gold standard. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MRI (mpMRI)
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Mar 2025to 25 Feb 2026
- 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 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The primary condition under investigation in this study is clinically significant prostate cancer, a malignant disease affecting the prostate gland in men. The study focuses on the diagnostic evaluation and detection of this condition using two commonly employed imaging techniques: Magnetic Resonance Imaging (MRI) and Transrectal Ultrasound (TRUS).
Who may be able to join
- Male patients who are 40 years of age or older
- Individuals who exhibit increased PSA values (e.g., PSA >4 ng/mL) or abnormal results on a digital rectal examination (DRE), which are clinical indicators of prostate cancer) 16
Who cannot join
- Individuals who have previously had treatment for prostate cancer, such as hormone therapy, chemotherapy, radiation, or surgery
- Severe comorbidities that make safe imaging or biopsy impossible, such as severe heart failure or end-stage renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Magnetic Resonance Imaging and Transrectal Ultrasound in Identifying Clinically Significant Prostate Cancer Among Diverse Ethnic Groups Using Histopathology as the Gold Standard
This study is designed to compare the diagnostic accuracy of Magnetic Resonance Imaging (MRI) and Transrectal Ultrasound (TRUS) in detecting clinically significant prostate cancer, using histopathology (biopsy results) as the gold standard. Prostate cancer is a leading cause of cancer-related morbidity among men globally, and its detection often varies across ethnic groups due to genetic, environmental, and healthcare access factors. This research aims to evaluate how MRI and TRUS perform across diverse ethnic populations to determine the most reliable imaging modality for early diagnosis.
Read the detailed description
The study will follow an observational, cross-sectional design. Patients suspected of having prostate cancer will undergo both MRI and TRUS imaging before a prostate biopsy. Imaging findings will be recorded and compared to the histopathological outcomes from biopsy samples. Sensitivity, specificity, positive predictive value, and negative predictive value will be calculated for each modality. Additionally, subgroup analysis will be performed to evaluate performance variations across different ethnic groups.
- Conditions
- Prostate Cancer
- Being tested
- MRI (mpMRI)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI (mpMRI)Diagnostic test
: Combines T2-weighted imaging, Diffusion-weighted imaging (DWI), and Dynamic contrast-enhanced MRI (DCE-MRI) to provide detailed anatomical images and assess tissue characteristics.
| Study group | Role | What they receive |
|---|---|---|
| MRI (mpMRI) | Not described Receives: Diagnostic Test: MRI (mpMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC QLQ-C30
The EORTC QLQ-C30 is a 30-item questionnaire used to assess the quality of life (QoL) of cancer patients. It consists of five functional scales, three symptom scales, a global health status/QoL scale, and six single-item symptom scales. Scoring involves calculating the average of items within each scale, then linearly transforming the scores to a 0-100 range, with higher scores generally indicating better functioning or higher symptom burden
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start17 Mar 2025
- Primary completion1 Jul 2025 (estimated)
- Study completion25 Feb 2026 (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 Superior UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048613
- Sponsor's protocol ID
- MSAHSW/Batch-Fall23/901
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Magnetic Resonance Imaging and Transrectal Ultrasound in Identifying Clinically Significant Prostate Cancer Among Diverse Ethnic Groups Using Histopathology as the Gold Standard
- ClinicalTrials.gov ID
- NCT07048613
- Acronym / sponsor ID
- MSAHSW/Batch-Fall23/901
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 25 Feb 2026 (estimated)
- First posted
- 2 Jul 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.
This study is designed to compare the diagnostic accuracy of Magnetic Resonance Imaging (MRI) and Transrectal Ultrasound (TRUS) in detecting clinically significant prostate cancer, using histopathology (biopsy results) as the gold standard. Prostate cancer is a leading cause of cancer-related morbidity among men globally, and its detection often varies across ethnic groups due to genetic, environmental, and healthcare access factors. This research aims to evaluate how MRI and TRUS perform across diverse ethnic populations to determine the most reliable imaging modality for early diagnosis.
Detailed description
The study will follow an observational, cross-sectional design. Patients suspected of having prostate cancer will undergo both MRI and TRUS imaging before a prostate biopsy. Imaging findings will be recorded and compared to the histopathological outcomes from biopsy samples. Sensitivity, specificity, positive predictive value, and negative predictive value will be calculated for each modality. Additionally, subgroup analysis will be performed to evaluate performance variations across different ethnic groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI (mpMRI) | – | Diagnostic Test: MRI (mpMRI) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The primary condition under investigation in this study is clinically significant prostate cancer, a malignant disease affecting the prostate gland in men. The study focuses on the diagnostic evaluation and detection of this condition using two commonly employed imaging techniques: Magnetic Resonance Imaging (MRI) and Transrectal Ultrasound (TRUS).
Key inclusion criteria (2 listed)
- Male patients who are 40 years of age or older
- Individuals who exhibit increased PSA values (e.g., PSA >4 ng/mL) or abnormal results on a digital rectal examination (DRE), which are clinical indicators of prostate cancer) 16
Key exclusion criteria (2 listed)
- Individuals who have previously had treatment for prostate cancer, such as hormone therapy, chemotherapy, radiation, or surgery
- Severe comorbidities that make safe imaging or biopsy impossible, such as severe heart failure or end-stage renal disease
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 |
|---|---|---|
| MRI (mpMRI): Combines T2-weighted imaging, Diffusion-weighted imaging (DWI), and Dynamic contrast-enhanced MRI (DCE-MRI) to provide detailed anatomical images and assess tissue characteristics. | Diagnostic test | MRI (mpMRI) |
Primary outcome
EORTC QLQ-C30
Time frame: 12 Months
The EORTC QLQ-C30 is a 30-item questionnaire used to assess the quality of life (QoL) of cancer patients. It consists of five functional scales, three symptom scales, a global health status/QoL scale, and six single-item symptom scales. Scoring involves calculating the average of items within each scale, then linearly transforming the scores to a 0-100 range, with higher scores generally indicating better functioning or higher symptom burden
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 2 Jul 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. 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, run by Superior University at 1 site in Pakistan.
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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2025. 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 Pakistan. 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?
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?
EORTC QLQ-C30 (time frame: 12 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 2 Jul 2025.