PROstate Cancer Risk Calculator for ACTionable Clinical Decision-making in Nigeria (PROACT)

July 24, 2026 updated by: Musliu Adetola Tolani, Ahmadu Bello University

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:

  1. How accurately do existing prostate cancer risk calculators identify Nigerian men with clinically significant prostate cancer?
  2. 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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

  1. 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.
  2. 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 Type

Interventional

Enrollment (Estimated)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Musliu Adetola TOLANI, MBBS PGCertPH ChM FWACS FMCS
  • Phone Number: +2348035646382
  • Email: adetolatolani@yahoo.com

Study Locations

  • Nigeria
    • Kaduna State
      • Zaria, Kaduna State, Nigeria
        • Ahmadu Bello University Teaching Hospital
        • Contact:
        • Principal Investigator:
          • Musliu Adetola TOLANI, MBBS PGCertPH ChM FWACS FMCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Training - Eligible primary care providers (for the training surveys) will be healthcare practitioners at community-level hospitals.
  2. Supported Risk Assessment

(i) 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.

(ii) Eligible patient participants (for the collection of observation data) will be the target population of adult males 40 - 79 years accessing provider services.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Training and Supported risk assessment
Other: (a) Training and (b) Supported risk assessment
  1. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of risk calculator use
Time Frame: 6 months
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.
6 months
Change in knowledge score following training
Time Frame: 3 days
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.
3 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants predicted to have clinically significant prostate cancer
Time Frame: 6 months
The proportion of participants classified by the risk calculator as having a predicted risk of clinically significant prostate cancer. The outcome will be reported as the number and percentage of participants predicted to have clinically significant prostate cancer among all assessed participants.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmadu Bello University

Collaborators

Fogarty International Center of the National Institute of Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2029

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

July 19, 2026

First Submitted That Met QC Criteria

July 24, 2026

First Posted (Actual)

July 29, 2026

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 24, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABUCUHSR/2025/022
  • 1K43TW013133-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

The scientific data will be made available no later than the time of publication of the study finding of the associated study aim, or at the end of the project. The validation dataset in this study will be archived indefinitely. Other data will be maintained on the secure platform for at least three years.

IPD Sharing Access Criteria

Data will also be shared upon request after compliance with the guidelines of Ahmadu Bello University Teaching Hospital Health Research Ethics Committee

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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