Prostate CancerPROACTNCT07733440
PROstate Cancer Risk Calculator for ACTionable Clinical Decision-making in Nigeria
A study testing (a) Training and (b) Supported risk assessment in people with Prostate Cancer and Risk Assessment, run by Ahmadu Bello University at 1 site in Nigeria.
Trial summary
This study is a pilot trial that builds on findings from the validation of prostate cancer risk calculators in Nigerian men. The goal of the overall study is to improve the early detection of prostate cancer in a high-risk population. The main questions the validation study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Risk Assessment, Clinical Decision Support Systems
- What is being tested?
- (a) Training and (b) Supported risk assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteNigeria
- Study dates
- Mar 2029to Aug 2029
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Training - Eligible primary care providers (for the training surveys) will be healthcare practitioners at community-level hospitals.
- Supported Risk Assessment
- Eligible key informants will be eligible primary care providers who were trained and implemented the supported risk assessment and the targeted population of patient participants who received the supported risk assessment.
- Eligible patient participants (for the collection of observation data) will be the target population of adult males 40 - 79 years accessing provider services.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nigeria1 site
Ahmadu Bello University Teaching Hospital
Zaria, Kaduna State
Musliu Adetola TOLANI, MBBS PGCertPH ChM FWACS FMCS, +2348035646382, adetolatolani@yahoo.com
Musliu Adetola TOLANI, MBBS PGCertPH ChM FWACS FMCS
About this study
Official title: Clinical Risk Calculator Validation and Implementation to Optimize Prostate Cancer Early Detection in Nigeria
This study is a pilot trial that builds on findings from the validation of prostate cancer risk calculators in Nigerian men. The goal of the overall study is to improve the early detection of prostate cancer in a high-risk population.
The main questions the validation study aims to answer are:
Read more
- How accurately do existing prostate cancer risk calculators identify Nigerian men with clinically significant prostate cancer?
- Will a new risk calculator designed for Nigerian men more accurately identify those with clinically significant prostate cancer?
The main questions the intervention study aims to answer is:
Will the primary care provider-facing risk calculator be feasible and acceptable for primary care providers to implement?
The intervention trial will be piloted among participants in community-level hospitals in order to primarily assess implementation outcomes
Read the detailed description
The validation study will use prospective data from 500 participants with suspicion of prostate cancer to compare the effectiveness of prostate cancer risk calculator(s).
The intervention study is the only specific aim that meets the definition of a Clinical Trial. This clinicaltrial.gov information is based on the intervention study.
- For training, healthcare practitioners from community-level hospitals will be invited to participate. Before the training, a pre-test questionnaire will be given to conveniently sampled attending participants. After the training, the same questionnaire will be given to the same participants. The pre- and post-training knowledge scores will be compared to see if there is a change in knowledge.
- Supported risk assessment with the risk calculator will be piloted for at least six months. Primary care providers at community-level hospitals will use the online risk calculator to assess prostate cancer risk in patient participants 40-79 years old who are accessing their services. After the risk assessment, we will evaluate feasibility and acceptability using a mixed methods approach.
- Conditions
- Prostate Cancer, Risk Assessment, Clinical Decision Support Systems, Predictive Value of Tests, Models, Algorithms
- Being tested
- (a) Training and (b) Supported risk assessment
- Keywords
- Prostate cancer, early detection, prostate cancer screening, early diagnosis, prostate specific antigen, risk calculator, risk prediction model, diagnostic accuracy, validation, prostate biopsy, primary care, implementation science, Africa, precision prevention, clinically significant prostate cancer, clinical prediction model, community oncology, Nigeria
- 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.
(a) Training and (b) Supported risk assessmentOther
- The training intervention will be facilitated by experienced clinical mentors through didactics and demonstrations and conducted as half-day sessions over 3 days
- This intervention includes risk calculator use and clinical mentorship for at least six months.
| Study group | Role | What they receive |
|---|---|---|
| Training and Supported risk assessment | Other | Not described Receives: Other: (a) Training and (b) Supported risk assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task completion rate
The percentage of risk calculator tasks successfully completed by providers during the risk assessment of patient participants. A task will be be considered successfully completed if all required steps are performed. Task completion will be documented using a standardized activity checklist and summarized using descriptive statistics.
Measured: 6 months
Perceived feasibility of risk calculator use
Feasibility will be assessed through participants' perceptions of the suitability of the risk calculator for its intended clinical purpose and its fit within routine clinical workflow. Data will be collected through qualitative feedback interviews and analyzed using thematic analysis.
Measured: 6 months
Secondary outcomes (2)
Acceptability of risk calculator use
Acceptability will be assessed through participants' perceptions of the content relevance and perceived complexity of the risk calculator for clinical decision-making. Data will be collected through qualitative feedback interviews and analyzed using thematic analysis.
Measured: 6 months
Change in knowledge score following training
Knowledge will be assessed using a structured questionnaire administered before and after training. Each questionnaire item will be scored as 1 for a correct response and 0 for an incorrect response. The total knowledge score will be calculated as the sum of correct responses. The change in knowledge score from pre-training to post-training assessment will be analyzed using inferential statistics.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study startMar 2029 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (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.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 1. Pre-post design for the training intervention (25 participants) 2. Pilot trial for the risk calculator implementation (64 participants)
- Masking
- None (open label)
- Enrolment
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmadu Bello University
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Musliu Adetola Tolani, Ahmadu Bello University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733440
- Sponsor's protocol ID
- ABUCUHSR/2025/022
- Other IDs
- 1K43TW013133-01
- Acronym
- PROACT
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The scientific data and metadata will be assigned a digital object identifier number. This citable link will be referenced in associated publications and discoverable during repository search.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Risk Calculator Validation and Implementation to Optimize Prostate Cancer Early Detection in Nigeria
- ClinicalTrials.gov ID
- NCT07733440
- Acronym / sponsor ID
- PROACT / ABUCUHSR/2025/022
- Conditions
- Prostate Cancer, Risk Assessment, Clinical Decision Support Systems, Predictive Value of Tests, Models, Algorithms
- Keywords
- Prostate cancer, early detection, prostate cancer screening, early diagnosis, prostate specific antigen, risk calculator, risk prediction model, diagnostic accuracy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- Ahmadu Bello UniversityUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- Mar 2029 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 29 Jul 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 is a pilot trial that builds on findings from the validation of prostate cancer risk calculators in Nigerian men. The goal of the overall study is to improve the early detection of prostate cancer in a high-risk population.
The main questions the validation study aims to answer are:
- How accurately do existing prostate cancer risk calculators identify Nigerian men with clinically significant prostate cancer?
- Will a new risk calculator designed for Nigerian men more accurately identify those with clinically significant prostate cancer?
The main questions the intervention study aims to answer is:
Will the primary care provider-facing risk calculator be feasible and acceptable for primary care providers to implement?
The intervention trial will be piloted among participants in community-level hospitals in order to primarily assess implementation outcomes
Detailed description
The validation study will use prospective data from 500 participants with suspicion of prostate cancer to compare the effectiveness of prostate cancer risk calculator(s).
The intervention study is the only specific aim that meets the definition of a Clinical Trial. This clinicaltrial.gov information is based on the intervention study.
- For training, healthcare practitioners from community-level hospitals will be invited to participate. Before the training, a pre-test questionnaire will be given to conveniently sampled attending participants. After the training, the same questionnaire will be given to the same participants. The pre- and post-training knowledge scores will be compared to see if there is a change in knowledge.
- Supported risk assessment with the risk calculator will be piloted for at least six months. Primary care providers at community-level hospitals will use the online risk calculator to assess prostate cancer risk in patient participants 40-79 years old who are accessing their services. After the risk assessment, we will evaluate feasibility and acceptability using a mixed methods approach.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 1. Pre-post design for the training intervention (25 participants) 2. Pilot trial for the risk calculator implementation (64 participants)
| Arm | Type | Receives |
|---|---|---|
| Training and Supported risk assessment | Other | Other: (a) Training and (b) Supported risk assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Training - Eligible primary care providers (for the training surveys) will be healthcare practitioners at community-level hospitals.
- Supported Risk Assessment
- Eligible key informants will be eligible primary care providers who were trained and implemented the supported risk assessment and the targeted population of patient participants who received the supported risk assessment.
- Eligible patient participants (for the collection of observation data) will be the target population of adult males 40 - 79 years accessing provider services.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| (a) Training and (b) Supported risk assessment1. The training intervention will be facilitated by experienced clinical mentors through didactics and demonstrations and conducted as half-day sessions over 3 days 2. This intervention includes risk calculator use and clinical mentorship for at least six months. | Other | Training and Supported risk assessment |
Primary outcome
Task completion rate
Time frame: 6 months
The percentage of risk calculator tasks successfully completed by providers during the risk assessment of patient participants. A task will be be considered successfully completed if all required steps are performed. Task completion will be documented using a standardized activity checklist and summarized using descriptive statistics.
Perceived feasibility of risk calculator use
Time frame: 6 months
Feasibility will be assessed through participants' perceptions of the suitability of the risk calculator for its intended clinical purpose and its fit within routine clinical workflow. Data will be collected through qualitative feedback interviews and analyzed using thematic analysis.
2 secondary outcomes
Acceptability of risk calculator use
Time frame: 6 months
Change in knowledge score following training
Time frame: 3 days
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 29 Jul 2026.
- Individual participant dataSharing planned: Yes. The scientific data and metadata will be assigned a digital object identifier number. This citable link will be referenced in associated publications and discoverable during repository search.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (a) Training and (b) Supported risk assessment in people with Prostate Cancer and Risk Assessment, run by Ahmadu Bello University at 1 site in Nigeria.
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 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 29 Jul 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 Nigeria. 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 Musliu Adetola TOLANI, MBBS PGCertPH ChM FWACS FMCS (+2348035646382, adetolatolani@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Task completion rate (time frame: 6 months). The study lists 2 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 29 Jul 2026.