Trans and Non-binary Prostate-Specific Antigen Reference Interval Determination Study (NCT06987045) | Clinical Trial Compass
RecruitingNot Applicable
Trans and Non-binary Prostate-Specific Antigen Reference Interval Determination Study
United Kingdom500 participantsStarted 2026-04-04
Plain-language 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.
Who can participate
Age range
40 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.