Recruiting

NCT Number: NCT06987045

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

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.

Recruiting

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Key information

Conditions

Prostate CA Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ambrose King Centre, Barts Health NHS Trust

London, United Kingdom

Location status: Recruiting

Location contact

James Hand

CONTACT

[email protected]

Kyle Ring

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

The primary endpoint is blood PSA concentration.

Time frame: 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 outcomes

Prostate Cancer

Time frame: 6months following end of enrolment

The numbers of participants diagnosed with prostate cancer during the study.

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Acronym: TransPRIDE

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: May 23, 2025
Registry last updated: Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting