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NCT06987045Recruiting

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

Source: ClinicalTrials.gov · Last updated 4 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
500 (estimated)
First submitted
15 May 2025
Start date
4 Apr 2026
Primary completion date
31 Mar 2028
Lead sponsor
Queen Mary University of London
NCT number
NCT06987045

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From 4 Apr 2026 to the primary completion date, 31 Mar 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • • 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

Who the study is looking for

  • • 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

Age in the registry: 40 years to 100 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ambrose King Centre, Barts Health NHS Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.