Early Diagnosis of PROstate CANcer for Black Men

NCT07620717 | Not Yet Recruiting

• 2 other identifiers: 101373G13007
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

PROCAN-B+ is a mixed-methods, two-arm, multi-centre randomised controlled trial evaluating a co-designed, peer-led intervention to encourage informed help-seeking and engagement with prostate cancer health checks and Prostate Specific Antigen (PSA) testing among Black men aged 45 years and over with no history of prostate cancer. The study will recruit 300 participants across three UK sites: North East England including Leeds, Scotland, and London. Following eligibility screening and baseline data collection, participants will be individually randomised in a 1:1 ratio to either the intervention or wait-list control arm by an independent clinical trials unit. Participants allocated to the intervention arm will attend a two-hour co-designed community-based workshop shortly after randomisation, while participants allocated to the control arm will be invited to attend the workshop following the 6-month follow-up period. Due to the nature of the intervention, participants and researchers will not be blinded to allocation. The intervention was co-designed in partnership with Black men and includes peer-led discussions on barriers to early diagnosis of prostate cancer, health education delivered by a Black GP, activities aimed at supporting effective communication with healthcare professionals, and video testimonials from prostate cancer survivors, women, and religious leaders. Primary outcomes include self-reported discussions with GPs relating to prostate cancer risk, self-reported PSA testing, and GP-recorded PSA testing where participant consent is provided. Secondary outcomes include knowledge of prostate cancer, attitudes towards prostate cancer health checks and PSA testing, and help-seeking behaviours. Data will be collected at baseline, 3-month, and 6-month follow-up. A qualitative process evaluation involving participants, peer facilitators, and professionals will explore experiences and acceptability of the intervention and inform future implementation and scale-up.

Conditions

Prostate Cancer (Diagnosis)

Keywords

Prostate Cancer; Early diagnosis; Black men; Participatory research

Outcome Measures

Primary Outcomes (3)

• Self-reported GP attendance to discuss prostate cancer health

  Participants will be asked whether they discussed their risk of prostate cancer with their GPs and whether they requested a PSA test

  Baseline, 3 months, 6 months

• Self-reported PSA test

  Participants will be asked if they had undergone a PSA test prior to the study and whether they underwent PSA testing following the intervention.

  Baseline, 3 months, 6 months

• GP recorded PSA tests

  If participants consent, they will be asked to provide details of their GP practice to verify whether they underwent or requested PSA testing following the intervention. Letters will be sent to each GP practice to confirm whether participants had requested or undergone PSA testing.

  6 months

Secondary Outcomes (3)

• Knowledge of prostate cancer

  Baseline, 3 months, 6 months

• Attitudes to prostate cancer

  Baseline, 3 months, 6 months

• Help-seeking behaviours

  Baseline, 3 months, 6 months

Other Outcomes (1)

• Perspectives on the intervention's content and delivery

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in this arm will attend a two-hour community workshop designed to encourage informed help-seeking and engagement with prostate cancer health checks and PSA testing.

Other: The intervention is a two-hour workshop that includes multiple components to encourage Black men to request prostate cancer diagnosis tests.

Control

OTHER

Participants in this arm will be placed on a waiting list and will be invited to attend the workshop after the 6-month follow-up period.

Other: Waitlist

Interventions

The intervention is a two-hour workshop that includes multiple components to encourage Black men to request prostate cancer diagnosis tests. OTHER

The intervention was co-designed in partnership with 13 Black men to address barriers and facilitators to early diagnosis of prostate cancer among Black men. The workshop includes multiple components, including peer-led discussions on barriers to early diagnosis, health education delivered by a Black GP, activities aimed at supporting effective communication with GPs and reception staff, and video testimonials from prostate cancer survivors, women, and religious leaders.

Intervention

Waitlist OTHER

Participants in the control group will be placed on a waitlist to receive the intervention after six months

Control

Eligibility Criteria

• Age: 45 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Black men aged 45 years or over, living in North East England, North Yorkshire, London or Scotland

You may not qualify if:

• Men from other ethnicities
• Black men aged less than 45 years
• Black men with previous prostate cancer diagnosis

Sponsors & Collaborators

• University of Sunderland: lead
• University of Glasgow: collaborator

Related Publications (1)

• Christie-de Jong F, Eberhardt J, Oyeniyi OS, Ratcliffe E, Kabuye J, Kalemba M, Nnyanzi LA, Murphy MK, Robb KA. A mixed-methods evaluation of a peer-led, co-produced, asset-based intervention for early diagnosis of prostate cancer for Black men: the PROCAN-B study. BMJ Open. 2025 Nov 9;15(11):e105803. doi: 10.1136/bmjopen-2025-105803.

  PMID: 41213686 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Interventions

Waiting Lists

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

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Floor Christie-de Jong

  University of Sunderland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Floor Christie-de Jong

CONTACT

0044 191 5153445; Floor.Christie-DeJong@sunderland.ac.uk

Rawand Jarrar

CONTACT

rawand.jarrar@sunderland.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Public Health for Medicine

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: We will aim to publish the study protocol in the first year of the study. Findings will be published following study completion.
• Access Criteria: Following study completion and publication of the main study findings, anonymised and de-identified data will be available from the principal investigator upon reasonable request and in accordance with ethical and data protection requirements.