Status:
NOT_YET_RECRUITING
Trans and Non-binary Prostate-Specific Antigen Reference Interval Determination Study
Lead Sponsor:
Queen Mary University of London
Conditions:
Prostate CA
Eligibility:
All Genders
40-100 years
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 a...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 15 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06987045
Start Date
August 1 2025
End Date
October 15 2027
Last Update
May 23 2025
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