Clinical trial NCT06987045: Trans and Non-binary Prostate-Specific Antigen Reference Interval Determination Study
Official title: Trans and Non-binary Prostate-Specific Antigen Reference Interval Determination Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate CA
Keywords: Prostate Cancer
Transwomen
Non-binary
prostate
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: The primary endpoint is blood PSA concentration.
timeFrame: 6months following end of enrolment
Secondary outcomes:
measure: Prostate Cancer
timeFrame: 6months following end of enrolment
Other outcomes:
Locations:
Study officials:
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