Trans and Non-binary Prostate-Specific Antigen Reference Interval Determination Study

Not yet recruiting

• Conditions: Prostate CA

• Registration Number: NCT06987045
• Lead Sponsor: Queen Mary University of London

Brief Summary

The prostate specific antigen (PSA) blood test can help diagnose prostate problems, including cancer.

The prostate is an organ in the pelvis. It is found in cisgender men, transgender (trans) women and some non-binary people.

Anyone with a prostate can get prostate cancer. The prostate remains after genital (lower) surgery. The hormones and surgeries that trans women and non-binary people might have can lower the PSA. We do not have good data on the normal PSA levels are for this group

TransPRIDE is a research study that will help us find the normal levels of PSA in trans women and non-binary people with prostates.

Researchers will ask 500 trans women and non-binary people with prostates to take part. They will need to be aged 40 or over. They will need to be on hormones or have had lower surgery. They will be called after 6 months to recheck their health. If a person has a high PSA, they may be sent for more tests.

Knowing the normal PSA level for trans women and non-binary people will help doctors to find and treat their prostate cancer more quickly.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Study Start: 2025-08-01
• Primary Completion: 2026-10-15
• Study Completion: 2027-10-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• • Aged >40

  • Transgender or non-binary (identify with a gender other than the one assigned at birth)

  • With a prostate

  • Fulfills at least one of the following 3 criteria with regards to gender-affirming medical care:

    • Taking oestradiol for at least the last 3 months
    • Taking anti-androgens for at least the last 3 months
    • Ever had bilateral orchidectomy

  • Eligible for National Health Service (NHS) treatment

Exclusion Criteria

• • History of prostate cancer (Prostate cancer) at any time

  • History of prostate surgery at any time
  • History of prostate radiotherapy at any time
  • History of benign prostatic hypertrophy (enlarged prostate) at any time
  • Vaginoplasty within 12 months
  • Orchidectomy or vulvoplasty within three months
  • Sexually Transmitted Infection (STI) within 6 weeks of blood sample
  • Active urinary infection or within 6 weeks of blood sample
  • Prostatitis within 6 weeks of blood sample
  • Urological intervention (e.g. prostate biopsy) within 6 weeks of blood sample
  • Unwilling to give consent
  • Lacking capacity to give consent
  • In the secure estate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is blood PSA concentration.	6months following end of enrolment	The 95th percentile will be used to define the upper reference value of PSA values in healthy individuals; this will be estimated separately for each age group (i.e. 40-49, 50-59, 60-79, 70+).

Secondary Outcome Measures

Name	Time	Method
Prostate Cancer	6months following end of enrolment	The numbers of participants diagnosed with prostate cancer during the study.