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

June 3, 2026 updated by: Queen Mary University of London

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Trans and non-binary people with a prostate (TNBPP) who are taking Gender-Affirming Hormone Therapy (GAHT) and/or have had bilateral orchidectomy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
40-49 year olds
50-59 year olds
60-79 year olds
70+ year olds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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+).
6months following end of enrolment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostate Cancer
Time Frame: 6months following end of enrolment
The numbers of participants diagnosed with prostate cancer during the study.
6months following end of enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

May 15, 2025

First Submitted That Met QC Criteria

May 15, 2025

First Posted (Actual)

May 23, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 336982

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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