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

NCT07733440 | Not Yet Recruiting

• 2 other identifiers: ABUCUHSR/2025/0221K43TW013133-01
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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. 1.How accurately do existing prostate cancer risk calculators identify Nigerian men with clinically significant prostate cancer?
2. 2.Will a new risk calculator designed for Nigerian men more accurately identify those with clinically significant prostate cancer?

Conditions

Prostate Cancer; Risk Assessment; Clinical Decision Support Systems; Predictive Value of Tests; Models; Algorithms; Evidence-Based Practice; Implementation Research; Community Health Services; Primary Health Care; Biomarker; Prostate Specific Antigen; Global Health; Africa; Nigeria

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (2)

• Acceptability of risk calculator use

  6 months

• Change in knowledge score following training

  3 days

Other Outcomes (1)

• Proportion of participants predicted to have clinically significant prostate cancer

  6 months

Study Arms (1)

Training and Supported risk assessment

OTHER

Other: (a) Training and (b) Supported risk assessment

Interventions

(a) Training and (b) Supported risk assessment OTHER

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.

Training and Supported risk assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Training - Eligible primary care providers (for the training surveys) will be healthcare practitioners at community-level hospitals.
• 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.

Sponsors & Collaborators

• Ahmadu Bello University: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Ahmadu Bello University Teaching Hospital

Zaria, Kaduna State, Nigeria

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Musliu Adetola TOLANI, MBBS PGCertPH ChM FWACS FMCS

CONTACT

+2348035646382; adetolatolani@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: 1. Pre-post design for the training intervention (25 participants) 2. Pilot trial for the risk calculator implementation (64 participants)

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): March 1, 2029
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE
• 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.
• Access Criteria: Data will also be shared upon request after compliance with the guidelines of Ahmadu Bello University Teaching Hospital Health Research Ethics Committee

Locations

NG (1)