Normal PSA levels for trans women and non-binary people with prostates
Official title: Trans and Non-binary Prostate-Specific Antigen Reference Interval Determination Study
Run by Queen Mary University of London · NCT06987045 · Data updated 2026-11-12
This study tests normal PSA reference levels in trans women and non-binary people who have prostates and are 40 or older.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 40 Years to 100 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Queen Mary University of London Academic / other |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | April 4, 2026 |
| Main results expected | March 31, 2028 |
| Study ends | March 31, 2028 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT06987045 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 40 or older, assigned male at birth, who identify as transgender or non-binary, have a prostate, and are on hormone therapy or have had lower surgery.
✕Probably not a fit
People who do not fit the eligibility criteria or who have a history of prostate cancer or recent prostate procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to establish typical PSA reference intervals for transgender women and non-binary individuals with prostates who are undergoing gender-affirming hormone therapy or surgery. About 500 participants will provide blood samples and be followed up after six months to see if PSA values remain within expected ranges. Researchers will exclude individuals with a history of prostate cancer, recent prostate procedures, or active infections that could affect PSA results. The goal is to improve interpretation of PSA tests in this population and support cancer screening decisions.
Why it matters
Potential benefit: If successful, the study could provide more accurate PSA reference ranges for trans women and non-binary people with prostates, improving cancer screening accuracy.
How similar studies have gone: Previous prostate PSA research has largely focused on cisgender populations; this study is novel in specifically including trans women and non-binary individuals with prostates.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Ambrose King Centre, Barts Health NHS Trust
London, United Kingdom Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.