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

NCT06987045 | Not Yet Recruiting DMC

• 1 other identifier: 336982
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prostate CA

Keywords

Prostate Cancer; Transwomen; Non-binary; prostate

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is blood PSA concentration.

  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 Outcomes (1)

• Prostate Cancer

  6months following end of enrolment

Study Arms (4)

40-49 year olds

50-59 year olds

60-79 year olds

70+ year olds

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary University of London: lead

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: March 31, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share